Article Date: 6/1/2011

CLINICAL TRIAL UPDATE

Clinical Trial Update

DRY AMD

Study: Safety and Tolerability of Sub-retinal Transplantation of hESC Derived RPE (MA09-hRPE) Cells in Patients With Advanced Dry Age-Related Macular Degeneration
Sponsor: Advanced Cell Technology
Purpose: To evaluate the effect of subretinal injection of human embryonic stem cell derived retinal pigment epithelium cells in patients with dry age-related macular degeneration (AMD) and to perform exploratory evaluation of potential efficacy endpoints to be used in future studies retinal pigment epithelium (RPE) cellular therapy
Design: Interventional, Safety, Single-group Assignment, Open Label
Number of Patients: 12
Inclusion Criteria: Clinical findings consistent with advanced dry AMD with evidence of one or more areas of >250microns of geographic atrophy (as defined in the Age-Related eye Disease Study [AREDS] study) involving the central fovea; GA defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, and FA; no evidence of current or prior choroidal neovascularization
Exclusion Criteria: Presence of active or inactive CNV; presence or history of retinal dystrophy, retinitis pigmentosa, chorioretinitis, central serious choroidopathy, diabetic retinopathy or other retinal vascular or degenerative disease other than ARMD; history of optic neuropathy
Information: schwartz@jsei.ucla.edu

Study: A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy
Sponsor: Genentech
Purpose: To evaluate the safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections administered monthly or every other month in patients with geographic atrophy
Design: Randomized, Parallel Assignment, Single-blind, Treatment
Number of Patients: 120
Inclusion Criteria: Well-demarcated area of GA secondary to age-related macular degeneration (AMD) in the absence of choroidal neovascularization (CNV)
Exclusion Criteria: history of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye; previous subfoveal focal laser photocoagulation in the study eye; laser photocoagulation in the study eye; prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
Information: sullivan.amy@gene.com

Study: A Study of the Safety and Efficacy of CNTO2476 in Patients With Age-related Macular Degeneration
Sponsor: Centocor, Inc.
Purpose: To assess the effects (good and bad) of a therapy called CNTO 2476 for patients with age-related macular degeneration
Design: Interventional, Randomized, Safety/Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: Not given
Inclusion Criteria: Patient is a suitable candidate for ophthalmologic surgery, is willing and able to comply with the surgical procedure, scheduled visits, treatment plan, laboratory tests and other study procedures; confirmed diagnosis of bilateral geographic atrophy (GA) of the macula bilaterally caused by age-related macular degeneration
Exclusion Criteria: Evidence of other significant ophthalmologic disease; ocular hypertension; previous cell therapy other than blood components
Information: info1@veritasmedicine.com

Study: COMPLETE: Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration
Sponsor: University of Miami/Alexion Pharmaceuticals
Purpose: To evaluate the safety and efficacy of eculizumab for the treatment of dry AMD as evaluated by the change in drusen volume and area of geographic atrophy.
Design: Treatment, Randomized, Double-blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 60
Inclusion Criteria: In the study eye(s), the presence of non-exudative AMD documented by fundus photography, autofluorescence, fluorescein angiography, and spectral domain OCT; visual acuity of 20/63
Exclusion Criteria: Visual acuity worse than 20/63; any history of choroidal neovascularization in the study eye; unresolved meningococcal disease; confounding ocular conditions such as amblyopia; aphakia; myopia requiring >6 D of correction
Information: (305) 326-6148

Study: TORPA: Toronto and Oak Ridge Photobiomodulation Study for Dry Age-Related Macular Degeneration
Sponsor: Graham Merry, MD
Purpose: To evaluate clinical outcomes of Photobiomodulation treatment on patients with dry AMD
Design: Treatment, Open Label, Uncontrolled, Single-group Assignment, Safety/Efficacy Study
Number of Patients: 20
Inclusion Criteria: Best-corrected visual acuity between 20/40 and 20/200
Exclusion Criteria: Visually significant cataracts; presence of a visually significant posterior capsule if prior cataract has been performed
Information: (865) 483-6399

Study: A Multi-Center Study of Reading Rehabilitation in Macular Disease
Sponsor: Department of Veterans Affairs
Information: pdgrant@uic.edu

Study: Fluocinolone Acentonide Intravitreal Inserts in Geographic Atrophy
Sponsor: Alimera Sciences
Information: lschulz@med.wayne.edu

Study: Safety Study in Retinal Transplantation for Dry Age-Related Macular Degeneration
Sponsor: Ocular Transplantation; National Neurovision Research Institute
Information: nradtke@rvrc.com

Study: Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy
Sponsor: Acucela, Inc.
Information: www.acucela.com

Study: Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-Related Macular Degeneration
Sponsor: The New York Eye and Ear Infirmary
Information: ktai@nyee.edu

WET AMD

Study: Study of Dark Adaptation in Age-Related Macular Degeneration Sponsor: National Eye Institute
Purpose: To evaluate the effectiveness of using a dark adaptation protocol to identify and monitor early to middle dry age-related macular degeneration
Design: Observational, Prospective
Number of Patients: 200
Inclusion Criteria: Group 0: Participant without AMD defined as no large drusen or advanced AMD in either eye; Group 1: Participant has at least one large drusen (greater than or equal to 125 microns) in the study eye and no large drusen or advanced AMD in the fellow eye; Group 2: Participant has bilateral large drusen (greater than or equal to 125 microns) with or without retinal pigment epithelial hypo/hyperpigmentary changes; Group 3: Participant has at least one large drusen (greater than or equal to 125 microns) in the study eye and advanced AMD in the fellow eye
Exclusion Criteria: Participant has advanced AMD (as defined in Appendix 1) in the study eye at the baseline visit; participant has other active ocular or macular diseases (eg, diabetic macular edema, retinal vein occlusion, Stargardt's disease or cone-rod dystrophy) or other known ocular disorders that have caused a visual field deficit (eg, glaucoma with known visual field defect) in the study eye
Information: prpl@mail.cc.nih.gov

Study: CFH&AMD: Complement Factor H Haplotypes and Smoking in Age-related Macular Degeneration
Sponsor: Department of Veterans Affairs
Purpose: To the hypothesis that smoking increases age-related macular degeneration (AMD) by increasing complement activation; and that this is positively correlated with known disease variations in the complement factor H (CFH) gene
Design: Observational, Cohort, Prospective
Number of Patients: 300
Inclusion Criteria: Inclusion criteria for subjects will be a clear diagnosis of age-related macular degeneration (AMD)
Exclusion Criteria: We will exclude individuals with ocular diseases that might simulate age-related macular dengeration (AMD) or preclude its diagnosis
Information: rohrer@musc.edu

Study: Tools to Optimize Patient Presentation After Onset of Exudative Age-Related Macular Degeneration
Sponsor: Johns Hopkins University
Purpose: To demonstrate that use of the test booklet leads to more rapid identification of newly developing vision problems, earlier diagnosis and treatment of incipient wet AMD that should result in fewer people losing their vision and less severe losses of vision
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Open Label, Diagnostic
Number of Patients: 1000
Inclusion Criteria: Subjects with a confirmed diagnosis of AREDS grade 3 or 4 AMD in at least one eye will be recruited for components 1 and 2 of the study
Exclusion Criteria: Subjects with vision loss due to ocular pathology other than AMD or cataracts will be excluded
Information: gdagnelie@jhmi.edu

Study: iSONEP to Treat Persistent Pigment Epithelial Detachment (PED) in Subjects With Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV)
Sponsor: Lpath/Pfizer
Purpose: To evaluate the safety and potential efficacy of iSONEP following one, two or three injections of iSONEP, as needed, for the treatment of Pigment Epithelial Detachment (PED) secondary to PED Secondary to Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV)
Design: Randomized, Safety/Efficacy, Interventional, Single-group Assignment, Open Label, Treatment
Number of Patients: 32
Inclusion Criteria: Serous and/or fibrovascular PED secondary to exudative AMD or secondary to PCV (confirmed by SDOCT, FA and ICG) that has not demonstrated at least a 25% decrease in the height of the PED (from the onset of anti-VEGF therapy) following a minimum of 3 doses of an anti-VEGF agent (i.e., Lucentis or Avastin); PED that has a height greater than 100 µm; presence of CNV secondary to (i) AMD (based on FA) or (ii) PCV (based on ICG)
Exclusion Criteria: Subjects previously treated with, or are currently receiving treatment with another investigational agent or device for neovascular AMD in the study eye; Subjects who have received < 3 and > 7 anti-VEGF treatments in the study eye; Subjects with retinal angiomatous proliferation (RAP lesion)
Information: jada@crmd.net

Study: Safety and Preliminary Efficacy Study of WST11 (Stakel®)-Mediated VTP Therapy in Subjects With CNV Associated With AMD
Sponsor: Steba Biotech S.A.
Purpose: To evaluate the safety (first objective) and efficacy (second objective) of an experimental drug product, Stakel, in the treatment of neovascular AMD. The drug product is activated in patients by exposure to light at a specific wavelength (“Vascular Targeted Photodynamic therapy”, “VTP”)
Design: Interventional, Safety/Efficacy, Single-group, Open Label, Treatment
Number of Patients: 18
Inclusion Criteria: Twenty eight days or more after at least one ranibizumab injection, re current leakage on FA from subfoveal CNV (i.e., CNV previously diagnosed and treated with antivascular endothelial growth factor (VEGF) therapy resulting in resolution of leakage or optical coherence tomography (OCT) thickening but currently presenting with new fluorescein leakage from CNV associated with OCT thickening) secondary to AMD; total lesion size not exceeding 5400 µm in its greatest linear dimension; BCVA letter score of 73 to 23 in the study eye (approximate Snellen equivalent, 20/40 to 20/320) at a starting distance of 4 meters
Exclusion Criteria: Permanent structural damage to the center of the fovea of the study eye, or a concurrent ocular or systemic condition that could contraindicate administration of an investigational drug, Stakel Solution, or fluorescein, affect interpretation of study results, or render the subject at a high risk of treatment complications; subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either ≥50% of the total lesion area or ≥1 disc area in size; subfoveal fibrosis or atrophy in the study eye which is at least 50% of the lesion
Information: ascott28@jhmi.edu

Study: GEM: Phase I Dose Escalation Safety Study of RetinoStat in Advanced Age-Related Macular Degeneration (AMD)
Sponsor: Oxford BioMedica
Purpose: To examine the safety of an experimental gene transfer agent, RetinoStat, designed to treat neovascular age-related macular degeneration
Design: Interventional, Safety, Single-group Assignment, Open Label, Treatment
Number of Patients: 18
Inclusion Criteria: Clinical diagnosis of AMD with active CNV that shows evidence of leakage; BCVA less than or equal to 20/200 in the study eye
Exclusion Criteria: Significant ocular abnormalities that prevent retinal assessment; treatment with steroids within three months of screening; treatment with anti-VEGF therapy to either eye within one month of screening
Information: pcampo@jhmi.edu

Study: Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration
Sponsor: Novartis
Purpose: To assess the safety, tolerability, and serum pharmacokinetics of intravitreal LFG316 in patients with advanced age-related macular degeneration
Design: Interventional, Nonrandomized, Parallel Assignment, Open Label, Treatment Number of Patients: 30
Inclusion Criteria: Male or female AMD patients 55 to 90 years old, inclusive; in either eye, diagnosis of geographic atrophy or choroidal neovascularization due to AMD
Exclusion Criteria: Retinal disease other than AMD in study eye which, in the investigator's opinion, may pose a safety risk or interfere with the study; choroidal neovascularization due to a cause other than AMD; in the study eye, media opacity that interferes with fundus imaging or is likely to require surgery during the study period
Information: jminer@retinalconsultantsaz.com

Study: Serial Retinal Thickness Changes And Scotoma Size Measured With Lucentis Therapy (FVF4193s)
Sponsor: New York Eye & Ear Infirmary/Genentech
Purpose: To accurately measure anatomic response to treatments thereby enhancing the ability to understand patterns of response and predict the necessity for continued therapy
Design: Interventional, Active Control, Safety/Efficacy, Single Group, Open Label, Treatment
Number of Patients: 20
Inclusion Criteria: Best-corrected visual acuity in the study eye between 20/40 and 20/320; subfoveal choroidal neovascularization, secondary to age-related macular degeneration; any sub-retinal hemorrhage must comprise no more than 50% of total lesion size
Exclusion Criteria: Had ocular surgery within the past 60 days in the study eye; had previous refractive eye surgery (RK, PRK, LASIK, ALK, etc.) within the past 3 months for the study eye; has intraocular pressure >25 mm Hg in the study eye
Information: ktai@nyee.edu

Study: Prospective Randomized Trial of Proton Beam Combined With Anti-VEGF Therapy for Exudative Age-related Macular Degeneration
Sponsor: University of California, Davis
Purpose: To test the hypothesis that proton beam irradiation combined with intravitreal anti-VEGF therapy is safe and potentially more effective than intravitreal anti-VEGF therapy alone in eyes with exudative AMD
Design: Randomized, Placebo Control, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 45
Inclusion Criteria: Visual acuity 20/40 to 20/400; lesion size < 12 Disc Area; submacular hemorrhage less than 75% of total lesion and not involving foveal center; submacular fibrosis less than 25% of total lesion
Exclusion Criteria: Previous treatment with Photodynamic Therapy (PDT) or thermal laser in study eye; anti-VEGF therapy within 6 weeks; intravitreal or subtenon's Kenalog within 6 months; intraocular surgery within 3 months or expected in the next 6 months
Information: (916) 734-6074

Study: HiPED: High Dose Lucentis for Persistent Pigment Epithelial Detachments in Age-related Macular Degeneration
Sponsor: Pacific Eye Associates/Genentech
Purpose: To evaluate the efficacy and safety of 2 mg ranibizumab, specifically for patients with fibrovascular PEDs that have not resolved following at least 6 consecutive injections of ranibizumab or bevacizumab over the previous 12 months
Design: Interventional, Randomized, Dose Comparison, Safety/Efficacy, Parallel Assignment, Open Label, Treatment
Number of Patients: 40
Inclusion Criteria: Active or recurrent neovascular age-related macular degeneration involving the fovea on FA; presence of persistent fibrovascular pigment epithelial detachment on OCT following a minimum 6 previous treatments in previous 12 months with ranibizumab and/or bevacizumab. Patients may have received more than 12 months of anti-VEGF therapy; ETDRS best-corrected visual acuity 20/32 - 20/400
Exclusion Criteria: Prior treatment with verteporfin, or external-beam radiation therapy, or transpupillary thermotherapy; previous subfoveal focal laser photocoagulation involving the foveal center; history of vitrectomy, submacular surgery, or other surgical intervention for AMD; previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals) in study eye; lesion characteristics: subfoveal fibrosis or atrophy in study eye, CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
Information: pearesearch@yahoo.com

Study: Phase I Study of Palomid 529, a Dual TORC1/2 Inhibitor of the PI3K/Akt/m TOR Pathway for Advanced Neovascular AMD (P52901)
Sponsor: Paloma Pharmaceuticals, Inc.
Purpose: To determine if the safety, tolerability and pharmacokinetic profile of single ascending doses when administered intravitreally or subconjunctivally
Design: Interventional, Uncontrolled, Safety/Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: 33
Inclusion Criteria: Best-corrected visual acuity in the study eye between 20/100 and 20/800 (between 53 and 4 ETDRS letters read), and better or equal to 20/200 (minimum of 34 letters read) in the fellow eye; subfoveal choroidal neovascularization (CNV) due to AMD; total area of the lesion (including blood, neovascularization and scar/atrophy) must be <12 DA; only 1 eye will be treated in the study. If both eyes are eligible, the investigator will select the eye with the most active CNV
Exclusion Criteria: Any retinovascular disease or retinal degeneration other than AMD; serous pigment epithelial detachment without the presence of neovascularization; previous posterior vitrectomy or retinal surgery; any periocular infection in the past 4 weeks
Information: anowak@eyeboston.com

Study: IBI 20089+Lucentis Combo Intravitreal Injections for Treatment of Neovascular AMD (Icon Combo)
Sponsor: Univ. of Illinois/Icon Bioscience, Inc.
Purpose: To assess the safety and tolerability of an investigational drug called IBI-20089 (6.9 mg and 13.8 mg) when used adjunctively with Lucentis 0.5 mg in subjects with subfoveal neovascular AMD
Design: Interventional, Safety/Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: 5
Inclusion Criteria: Diagnosis of active, subfoveal choroidal neovascular membranes due to age-related macular degeneration; visual acuity from 20/50 to 20/400 in the study eye
Exclusion Criteria: Subjects who have received corticosteroids via any route in the past 90 days; in the opinion of the investigator, patient at risk of elevated ocular pressure or is known to be a steroid-responder; subjects with a history of ocular hypertension of glaucoma (Primary or Secondary); history of ocular surgery (invasive or non-invasive) in the past 90 days; intravitreal treatment with an anti-VEGF agent (eg, bevacizumab, ranibizumab, or pegaptanib) within 90 days of the enrollment (Day 0) examination
Information: alcmalek@uic.edu

Study: Dose Ranging Study of Pazopanib to Treat Neovascular AMD
Sponsor: GlaxoSmithKline
Purpose: To determine the safety and efficacy of different dosage regimens of pazopanib eye drops for the treatment of neovascular age-related macular degeneration
Design: Randomized, Safety/Efficacy Study, Parallel Assignment, Double-blind, Treatment
Number of Patients: 630
Inclusion Criteria: Active subfoveal CNV lesion secondary to AMD in study eye: Total lesion area ≤12 disc areas with CNV ≥50% total lesion area; anti-VEGF intravitreal injection experienced and in need of retreatment; BCVA of 24 to 78 letters (equates to approximately 20/32 to 20/320 Snellen equivalents)
Exclusion Criteria: Prior ocular investigational drug/device for choroidal neovascularization, photodynamic therapy, radiation, subfoveal or juxtafoveal focal laser photocoagulation; prior failure to anti-VEGF intravitreal injection therapy; recent ocular investigational drug/device for non-CNV condition; prior ocular surgeries (vitrectomy, scleral buckle, or glaucoma filtering/shunt surgery). Cataract surgery permitted if ≥3 months and has posterior chamber intraocular lens; center-fovea involvement of any of the following: fibrosis, atrophy, serous retinal pigment epithelial detachment, or retinal pigment epithelial tear
Information: (877) 379-3718

Study: LAST: A Pilot Study to evaLuate the Role of High-dose rAnibizumab (2.0mg) in the Management of AMD in Patients With perSistent/recurrenT Macular Fluid Less Than 30 Days Following Treatment With Intravitreal Anti-VEGF Therapy
Sponsor: Vitreous-Retina-Macula Consultants of New York
Purpose: To compare intravitreally administered 0.5 mg ranibizumab to 2.0 mg ranibizumab in subjects who manifest persistent or recurrent macular fluid less than 30 days following treatment with intravitreal anti-VEGF therapy
Design: Interventional, Randomized, Efficacy Study, Parallel Assignment, Single-blind, Treatment
Number of Patients: 30
Inclusion Criteria: Subfoveal neovascularization secondary to AMD; BCVA in the study eye between 20/30 to 20/400 using an ETDRS chart; documentation of the presence of sub-retinal fluid and/or cystoid macular edema on SD-OCT less than 30 days following at least six months of anti-VEGF therapy; presence of fibrosis, hemorrhage, or other hypofluorescent lesions should not obscure greater than 50% of the CNV lesion
Exclusion Criteria: Prior treatment with anti-VEGF therapy in the study eye within 30 days of BSL; prior treatment with triamcinolone in the study eye within six months of BSL; prior treatment with dexamethasone in the study eye within 30 days prior to BSL; past treatment with PDT or thermal laser in the study eye; intraocular surgery (including cataract surgery) in the study eye within two months preceding BSL; history of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye; active intraocular inflammation (grade trace or above) in the study eye; current vitreous hemorrhage in the study eye
Information: pguerrero@vrmny.com

Study: A Prospective Study Comparing Ranibizumab Plus Dexamethasone Combination Therapy Versus Ranibizumab Monotherapy for Wet AMD (Lucedex)
Sponsor: Bay Area Retina Associates
Purpose: To evaluate the safety of intravitreal ranibizumab in combination with intravitreal dexamethasone in comparison to intravitreal ranibizumab alone in the treatment of wet AMD
Design: Randomized, Safety, Parallel Assignment, Single-blind, Supportive-care
Number of Patients: 40
Inclusion Criteria: All lesion subtypes will be enrolled with the following criteria: Predominantly and minimally classic: angiographic lesion greater than 50% of the total lesion area; occult: lesions must show recent activity progression with respect to vision, subretinal hemorrhage or subretinal fluid
Exclusion Criteria: Previous treatment for AMD in the study eye; previous intravitreal drug delivery in the study eye; previous vitrectomy in the study eye; fibrosis or atrophy involving the center of the fovea in the study eye; neovascular membrane from any other concurrent retinal disease such as high myopia (SER > ·8D), histoplasmosis or other ocular inflammatory disease; known history of glaucoma and on more than one topical medication; history of glaucoma filtering surgery in the study eye; history of corneal transplant in the study eye
Information: lsray01@yahoo.com

Study: A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration
Sponsor: Ophthotech Corporation
Purpose: To evaluate the safety and efficacy of E10030 intravitreous injection when administered in combination with Lucentis against a control of Lucentis alone in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD)
Design: Randomized, Active Control, Safety/Efficacy Study, Parallel Assignment, Double-blind, Treatment
Number of Patients: 444
Inclusion Criteria: Subfoveal choroidal neovascularization (CNV) due to AMD
Exclusion Criteria: Diabetes mellitus; history or evidence of severe cardiac disease (eg, NYHA Functional Class III or IV, history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization within six months, or ventricular tachyarrhythmias requiring ongoing treatment; clinically significant impaired renal or hepatic function; stroke (within 12 months of trial entry); any major surgical procedure within one month of trial entry; known serious allergies to the fluorescein dye used in angiography (mild allergy amenable to treatment is allowable), to the components of the ranibizumab (Lucentis) formulation, or to the components of the E10030 formulation
Information: (919) 456-5103

Study: Safety and Tolerability Study of AAV2-sFLT01 in Patients With Neovascular Age-Related Macular Degeneration (AMD)
Sponsor: Genzyme
Purpose: To examine the safety and tolerability of an experimental gene transfer agent, AAV2-sFLT01, in patients with neovascular age-related macular degeneration (AMD)
Design: Treatment, Nonrandomized, Open Label, Parallel Assignment, Safety Study
Number of Patients: 34
Inclusion Criteria: Choroidal neovascular membrane (CNV) secondary to AMD, as confirmed by the patient's medical history and a documented diagnosis of CNV; subfoveal disciform scarring for the first part of the study (the dose-escalation part); patients must not have subfoveal disciform scarring in the second part of the study (the maximum tolerated dose part; adequate dilation of pupils to permit thorough ocular examination and testing
Exclusion Criteria: CNV in the study eye due to any reason other than AMD. Neutralizing antibody titers to AAV2 that are 1:1600; history of conditions in the study eye during screening which might alter visual acuity or interfere with study testing; active uncontrolled glaucoma; had any intraocular surgeries in the study eye within 3 months of enrollment or are known or likely candidates for intraocular surgery (including cataract surgery) in the study eye within 1 year of treatment; acute or chronic infection in the study eye; history of inflammation in the study eye or ongoing inflammation in either eye
Information: medinfo@genzyme.com

Study: Study of Intravitreal Microplasmin in Relieving Vitreo-Macular Adhesion in Neovascular Age-related Macular Degeneration (AMD)
Sponsor: University of California-Los Angeles/ThomboGenics
Purpose: To determine whether microplasmin given by intravitreal injection is effective and safe for the treatment of wet age-related macular degeneration (AMD) in patients who have focal vitreomacular adhesion (VMA)
Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Presence of focal vitreomacular adhesion as seen by OCT; BCVA of 20/800 or better in non-study eye; presence of active choroidal neovascular membrane
Exclusion Criteria: Subjects who have previously received microplasmin; subjects with any vitreous hemorrhage or any other vitreous opacification which precludes adequate examination or investigation of study eye; patient with uncontrolled glaucoma including IOP >25 mm Hg; subjects who have had vitrectomy or retinal detachment or who are aphakic or highly myopic (>8.0 D) in the study eye
Information: ostrick@jsei.ucla.edu

Study: Retinal and Retinal Pigment Epithelium (RPE) Autoimmunity in AMD—Correlation With Lucentis Therapy (Antibody)
Sponsor: University of California–Davis/Genentech
Information: dgtelander@ucdavis.edu

Study: A Phase 1 Ascending and Parallel Group Trial to Establish the Safety, Tolerability and Pharmacokinetics Profile of Volociximab (Alpha 5 Beta 1 Integrin Antagonist) in Subjects With Neovascular Age-Related Macular Degeneration
Sponsor: Ophthotech Corp.
Information: (212) 845-8214

Study: Evaluation of Dosing Interval of Higher Doses of Ranibizumab (BGB/IST)
Sponsor: Retina Vitreous Associates, P.C.; Genentech
Information: cawh@aol.com

Study: The MAP Study: FA/Medidur for AMD Pilot
Sponsor: Johns Hopkins Univ./Alimera Sciences
Information: ghafiz1@jhmi.edu

Study: Antioxidant Systems and AMD
Sponsor: Vanderbilt University/National Institutes of Health.
Information: paul.sternberg@vanderbilt.edu

Study: High Speed Indocyanine Green Angiography Findings in Ranibizumab Treatment for Wet AMD
Sponsor: National Eye Institute
Information: prpl@mail.cc.nih.gov

Study: Reduced Fluence PDT With Visudyne in Combination With Lucentis for Age-related Macular Degeneration
Sponsor: Oklahoma State University Center for Health Sciences/Novartis
Information: (918) 747-7799

Study: Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular AMD
Sponsor: Retina Macula Institute
Information: lillian.rmi@gmail.com

Study: ERG/EOG Study in AMD Patients Treated With Ranibizumab
Sponsor: Retina Center, Minnesota/Genentech
Information: vu@retinadocs.com

Study: Study of Treatment Effects of Combination Therapy of Lucentis Plus Reduced-Fluence PDT in Patients With Wet AMD
Sponsor: Barnes Retina Institute
Information: bristudies@barnesretinainstitute.com

DIABETIC MACULAR EDEMA

Study: Evaluation of Single Nucleotide Polymorphisms (SNPs) in Patients With and Without DME
Sponsor: National Eye Institute
Purpose: To investigate genetic factors that may influence the development of DME
Design: Time Perspective, Prospective
Number of Patients: 400
Inclusion Criteria: Participant is diagnosed with DME defined by fluorescein leakage associated with either central retinal thickness greater than 260 microns on spectral domain OCT or cystic changes present on OCT
Exclusion Criteria: Participant has another retinal disease that may confound evaluation of the DME (eg, vein occlusions, uveitic macular edema, wet AMD); participant has opacities of the ocular media, limitations of pupillary dilation or other problems sufficient to preclude adequate dilated examination
Information: prpl@mail.cc.nih.gov

Study: Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor in the Treatment of DME
Sponsor: National Eye Institute
Purpose: To test the safety and effectiveness of minocycline as a treatment for DME.
Design: Nonrandomized, Uncontrolled, Safety/Efficacy Study, Single-group Assignment, Open Label, Treatment
Number of Patients: 8
Inclusion Criteria: BCVA between 78 and 39 letters (ie, between 20/32 and 20/200); definite retinal thickening due to DME based on clinical exam involving the center of the macula that is not refractory to further therapy as based on the investigator's clinical judgment; previous treatment with focal laser photocoagulation following standard-of-care/best practice guidelines, as described by the ETDRS study, greater than or equal to three months prior to enrollment unless the edema is not responsive to previous laser and/or not amenable to safe laser treatment at the discretion of the investigator. The laser treatment may be performed at the NEI clinical center or by an outside ophthalmologist at the discretion of the participant and the investigator
Exclusion Criteria: The macular edema is considered to be related to cataract extraction or clinical exam and/or OCT suggest that vitreoretinal interface disease (eg, a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema
Information: prpl@mail.cc.nih.gov

Study: READ 3: Ranibizumab for Edema of the mAcula in Diabetes: Protocol 3 With High Dose
Sponsor: Johns Hopkins University/Juvenile Diabetes Research Foundation
Purpose: To investigate the safety, tolerability, bioactivity, and dose response of two different dosages (0.5 mg and 2.0 mg) of ranibizumab (RBZ) in patients with DME
Design: Treatment, Randomized, Single-blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 92
Inclusion Criteria: Diagnosis of diabetes mellitus (type 1 or type 2); serum HbA1c ≥5.5% within 12 months of randomization. Retinal thickening secondary to diabetes (DME) involving the center of the fovea; diagnosis must be confirmed by fluorescein angiography and OCT images; foveal thickness of ≥250 µm; best-corrected visual acuity score in the study eye of 20/40 to 20/320 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters); the non-study eye must be ≥20 letters (approximate Snellen equivalent 20/400); in the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from DME and not from other obvious causes of decreased vision
Exclusion Criteria: PRP or macular photocoagulation within 3 months of study entry in the study eye; use of intraocular or periocular injection of steroids in the study eye (eg, triamcinolone) within three months of study entry; previous participation in a study and receipt of antiangiogenic drugs within two months of study entry; proliferative diabetic retinopathy in the study eye, with the exceptions of inactive, fibrotic proliferative diabetic retinopathy that has regressed following panretinal laser photo-coagulation or tufts of NVE <1 disc area with no vitreous hemorrhage
Information: jdenton2@jhmi.edu

Study: SAR 1118 in Human Subjects Undergoing Pars Plana Vitrectomy
Sponsor: Johns Hopkins Univ./SARcode Corp.
Purpose: To determine the safety, tolerability, and pharmacokinetics of SAR 1118 within the anterior and posterior chamber of the eye and plasma in subjects undergoing elective vitrectomy when treated with escalating concentrations of the study drug for approximately 1 week
Design: Treatment, Randomized, Single-blind (Subject), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Current non-smoker (last date of smoking should be at least 60 days before study enrollment); surgically eligible to undergo elective PPV including, but not limited to, epiretinal membrane
Exclusion Criteria: Vitreous hemorrhage; active retinal detachment; autoimmune disease of the anterior segment or posterior chamber including chronic keratoconjunctivitis sicca, uveitis, iritis/scleritis, blepharitis of either eye

Study: Macular Edema Incidence/Severity Reduction With Nevanac
Sponsor: Alcon
Purpose: To determine the safety and efficacy of Nevanac for the prevention of macular edema in patients with diabetic retinopathy within 90 days following cataract surgery
Design: Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Number of Patients: 260
Inclusion Criteria: NPDR (mild, moderate or severe) in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale; central subfield macular thickness ·320 µm in the study eye prior to cataract surgery as determined by SD-OCT and confirmed by the reading center; absence of CME or cystoid abnormalities in the study eye as detected by SD-OCT and confirmed by the reading center
Information: (800) 451-3937

Study: Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Diabetic Macular Edema
Sponsor: Mount Sinai School of Medicine
Purpose: To determine if intravitreal infliximab is a safe and effective treatment for macular edema secondary to diabetes
Design: Treatment, Open Label, Single-group Assignment, Efficacy Study
Number of Patients: 10
Inclusion Criteria: Participant has DME that is not amenable to treatment with laser photocoagulation or has been refractory to laser photocoagulation; participant must have a negative PPD skin test; participant must understand and sign the proto col's informed consent document; participants must have DME as defined by all of the following criteria: presence of diabetes (type I or type II) and macular edema defined as a central macular thickness of ≥250 µm on OCT; participant must have visual acuity between 20/40 and hand motions in the study eye; participant must have a steady fixation in the study eye and media clear enough for good quality imaging
Exclusion Criteria: Participant has proliferative diabetic retinopathy; participant is unable to comply with study procedures or follow-up visits; participant has multiple sclerosis or symptoms suggestive of multiple sclerosis; participant has evidence of ocular disease other than DME in either eye that may confound the outcome of the study (eg, uveitis, age-related macular degeneration, vitreomacular traction, moderate/severe myopia, etc.); participant is expected to need ocular surgery or panretinal photocoagulation in the study eye during the course of the study; participant has undergone ocular surgery or an intravitreal/periocular steroid injection in the study eye within the past 3 months; participant has had a YAG laser capsulotomy or intravitreal anti-VEGF treatment in the study eye within the past 6 weeks
Information: rojeoktay.kacmaz@mssm.edu

Study: Near-Infrared Light Therapy for Diabetic Macular Edema: A Pilot Study
Sponsor: Medical College of Wisconsin
Information: hwhelan@mcw.edu

Study: Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)
Sponsor: Genentech/Michael J. Jumper
Information: jrose@westcoastretina.com

Study: Intravitreal Infliximab for Diabetic Macular Edema and CNV
Sponsor: Retina Research Foundation
Information: (518) 533-6550

RETINAL VEIN OCCLUSION

Study: Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion
Sponsor: Maturi, Raj K., M.D., P.C.
Purpose: To see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes
Design: Interventional, Randomized, Efficacy, Parallel Assignment, Single-blind, Treatment
Number of Patients: 40
Inclusion Criteria: Branch retinal vein occlusion or central retinal vein occlusion of less than one year duration; best-corrected visual acuity of greater than 24 and less than 80; presence of macular edema defined as OCT central subfield thickness of >250
Exclusion Criteria: Intravitreal anti-VEGF treatment in study eye within six weeks of baseline; intravitreal steroid treatment in the study eye within eight weeks of baseline visit; PRP in the study eye within 4 month of baseline visit; active iris neovascularization in study eye
Information: eyeresearch2000@yahoo.com

Study: Anatomic Outcomes Following Ozurdex Injections
Sponsor: Barnes Retina Institute/Allergan
Purpose: To utilize frequent spectral-domain OCT imaging to better understand the onset of treatment effectiveness and duration of action on the anatomic thickness of the retina, in addition to distinguishing structual abnor malities of responders from non-responders
Design: Observational, Case-Only, Prospective
Number of Patients: 20
Inclusion Criteria: Patients diagnosed with BRVO/CRVO who are otherwise eligible to recieve treatment with Ozurdex
Exclusion Criteria: Patients younger than 21 years of age, unwilling or unable to grant informed consent, participation in a clinical trial within the 30 days prior to enrollment; patients receiving any other ocular therapy
Information: (314) 367-1278 ext 2287

Study: Lucentis for Macular Edema Associated With Central Retinal Vein Occlusion
Sponsor: California Retina Consultants/Genentech
Purpose: To determine whether ranibizumab (Lucentis) will be effective in reducing if not eliminating the macular edema associated with the disease, central retinal vein occlusion
Design: Interventional, Randomized, Uncontrolled, Safety/Efficacy, Crossover Assignment, Open Label, Treatment
Number of Patients: 20
Inclusion Criteria: Clinical evidence of perfused central retinal vein occlusion. A central retinal vein occlusion (CRVO) is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. Other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head
Exclusion Criteria: Significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy; evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema
Information: mdrabena@yahoo.com

Study: REVOLUTION: REtinal Vein OccLUsion Treatment With Scatter Laser Guided by UWFA in combiNAtion With Ranibizumab Study
Sponsor: Retinal Associates of Florida, PA
Purpose: To compare the gold standard of monthly ranibizumab injections with ranibizumab + peripheral scatter laser to the areas of nonperfusion on angiography
Design: Interventional, Randomized, Active Control, Safety/Efficacy, Parallel Assignment, Single-blind, Treatment
Number of Patients: 20
Inclusion Criteria: Fovea-involved macular edema of less than 12 months peripheral nonperfusion defined as at least 5 disc areas of contiguous nonperfusion on ultra-widefield fluorescein angiography absence of macular traction on clinical exam, UWFA, and OCT; study eye with best-corrected visual acuity between 20/40 (· 73 letters on ETDRS chart) and 20/320 (· 19 letters on ETDRS chart)
Exclusion Criteria: Therapy with intravitreal triamcinolone, pegaptanib, ranibizumab, or bevacizumab within the previous 3 months; previous macular or panretinal scatter laser photocoagulation; previous pars plana vitrectomy
Information: ivansuner@gmail.com

Study: Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by CRVO
Sponsor: Long Island Vitreoretinal Consultants
Purpose: To compare visual improvement and total number of intraocular injections in eyes with macular edema following CRVO after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab)
Design: Randomized, Active Control, Efficacy, Parallel Assignment, Single-blind, Treatment
Number of Patients: 30
Inclusion Criteria: ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/40 to 20/800; OCT Central foveal thickness >250 microns
Exclusion Criteria: History of glaucoma in the study eye with IOP >21mmHg on more than one topical medication. Combination drugs are considered more than one medication; History of steroid-related glaucoma (steroid response); Previous intraocular injection of steroid within 90 days; Avastin or Lucentis within 60 days
Information: (516) 466-0390

Study: RAVE 2: Study of 2.0 mg Ranibizumab in Subjects With Ischemic CRVO
Sponsor: Greater Houston Retina Research
Purpose: To conduct a phase I, open label, 12-month trial of intravitreal ranibizumab 2.0 mg in patients with ischemic CRVO who have been either previously treated with ranibizumab or treatment naïve
Design: Nonrandomized, Safety/Efficacy, Parallel Assignment, Open Label, Treatment
Number of Patients: 20
Inclusion Criteria: Ischemic CRVO within 3 months of enrollment
Exclusion Criteria: VA 20/200 or worse; RAPD 0.9 LU or worse; loss of 1-2e isopter on Goldmann Visual field
Information: (713) 524-3434

Study: Safety and Efficacy of AGN208397 in Treatment of ME Associated with RVO
Sponsor: Allergan
Purpose: To valuate the safety and efficacy of a single intravitreal injection of AGN208397 to treat macular edema associated with RVO
Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 117
Inclusion Criteria: Macular edema due to retinal vein occlusion; visual acuity in the study eye between 20/320 to 20/40
Exclusion Criteria: Cataract surgery or LASIK within 3 months prior to study Day 1 or anticipated need for cataract surgery during study period (12 months); use of injectable drugs in the study eye within 2 months prior to day 1; active eye infection in either eye; visual acuity in the non-study eye of 20/200 or worse
Information: clinicaltrials@allergan.com

Study: RELATE: Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions
Sponsor: Johns Hopkins University/Genentech
Purpose: To evaluate the safety and tolerability of intraocular injections of 0.5 or 2.0 mg of ranibizumab in patients with macular edema due to retinal vein occlusion
Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
Number of Patients: 80
Inclusion Criteria: Diagnosis of macular edema due to central or branch retinal vein occlusion; foveal thickness of equal to or greater than 250 mm, as assessed by OCT; BCVA score in the study eye of 20/40 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters). Only one eye will be treated in the study. If both eyes are eligible, the investigator will select the eye to be enrolled; in the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from vein occlusion and not from other obvious causes of decreased vision
Exclusion Criteria: Scatter laser photo-coagulation or macular photocoagulation within 3 months of study entry in the study eye; intraocular surgery in the study eye within 3 months of study entry; use of intraocular or periocular injection of steroids in the study eye (eg, triamcinolone) within 4 months of study entry; previous use of an anti-VEGF drug within 3 months of study entry; cataract surgery in the study eye within 3 months of study entry; Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 1 month of study entry; or any other intraocular surgery within 3 months preceding Day 0
Information: ghafiz@jhmi.edu

Study: FAVOR: Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina
Sponsor: Alimera Sciences
Purpose: To assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO
Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Number of Patients: 20
Inclusion Criteria: Diagnosis of macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO); central subfield thickness >300 µm; BCVA of ·24 and ·68 letters
Exclusion Critieria: Macular edema secondary to any condition other than RVO; presence of foveal atrophy, dense pigmentary changes or dense subfoveal exudates in the study eye; cystic intraretinal hemorrhage involving the fovea in the study eye that is responsible for vision loss; glaucoma or ocular hypertension (IOP >21 mm Hg or concurrent therapy at screening with IOP-lowering agents); any prior treatment with intravitreal, subtenon, or periocular steroid or anti-VEGF therapy since the diagnosis of RVO in the study eye; any change in systemic steroid therapy within 3 months of screening; history of vitrectomy in the study eye
Information: Kathleen.billman@alimerasciences.com

Study: A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion
Sponsor: Duke University/Bausch + Lomb, Inc.
Purpose: To determine whether a fluocinolone sustained drug delivery implant is effective in the treatment of central retinal vein occlusion that has caused persistent macular edema and decreased visual acuity
Design: Interventional, Nonrandomized, Single-group Assignment, Open Label, Treatment
Number of Patients: 30
Inclusion Criteria: A history of central retinal vein occlusion that had caused macular edema, based on clinical evaluation and demonstrated on fundus photography, fluorescein angiography, and optical coherence tomography (OCT); macular edema at least one disc area in size that involved the fovea
Exclusion Criteria: Patients are excluded if they have an allergy to fluocinolone acetonide or any component of the delivery system, a peripheral retinal detachment in the area of implantation, or media opacity precluding evaluation of study eye status; patients with disciform scars of the fovea or atrophic changes of the macula that in the investigator's opinion would preclude benefit from treatment are excluded from the study
Information: (919) 684-4458

Study: Effectiveness and Safety of Niacin and a Topical Steroid to Treat RVO
Sponsor: Palo Alto Medical Foundation
Purpose: To determine whether Niacin, a B vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye. The topical steroid eye drops are aimed at reducing swelling in the retina, until the collateral vessels have a chance to develop
Design: Nonrandomized, Active Control, Safety/Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: 68
Inclusion Criteria: Patient must have central retinal vein occlusion, hemi-retinal vein occlusion or branch retinal vein occlusion
Exclusion Criteria: Patients with active gout, or high levels of uric acid
Information: gaynonM@pamf.org

Study: Fluocinolone Acetonide Implant for RVO
Sponsor: Duke University; Bausch + Lomb
Purpose: To determine whether a fluocinolone acetonide sustained drug delivery implant is effective in the treatment of retinal vein occlusion that has caused persistent macular edema and decreased visual acuity
Design: Interventional, Nonrandomized, Safety/Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: 30
Inclusion Criteria: A history of retinal vein occlusion that had caused macular edema, based on clinical evaluation and demonstrated on fundus photography, fluorescein angiography, and optical coherence tomography (OCT); macular edema at least one disc area in size that involved the fovea; IOP controlled at < 21 mmHg with no more than one topical ocular antihypertensive agent
Exclusion Criteria: Patients are excluded if they have an allergy to fluocinolone acetonide or any component of the delivery system, a peripheral retinal detachment in the area of implantation, or media opacity precluding evaluation of study eye status; patients with disciform scars of the fovea or atrophic changes of the macula that in the investigator's opinion would preclude benefit from treatment are excluded from the study
Information: jaffe001@mc.duke.edu

Study: Intravitreal Ranibizumab Treatment of CRVO With Macular Edema
Sponsor: Vitreous-Retina Macula Consultants of New York/Genentech
Purpose: To examine the effects of Lucentis for active Central Retinal Vein Occlusion with Macular Edema
Design: Nonrandomized, Safety, Single-group Assignment, Open Label, Treatment
Number of Patients: 45
Inclusion Criteria: Clinical evidence of perfused central retinal vein occlusion. A central retinal vein occlusion (CRVO) is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. Other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head; central macular edema present on clinical examination and OCT testing with a central point thickness > 250 microns; visual acuity score greater than or equal to 34 letters (20/200) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol; media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography
Exclusion Criteria: Participation in another simultaneous ocular investigation or trial; patient with uncontrolled hypertension; patient has a condition that, in the opinion of the investigator would preclude participation in the study (ie, chronic alcoholism, drug abuse); patient has significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy; exam or OCT reveals evidence of vitreoretinal interface abnormality that may be contributing to the macular edema; eye that in the investigator has no chance of improvement in visual acuity following resolution of macular edema (i.e subretinal fibrosis or geographic atrophy)
Information: pguerrero@vrmny.com

Study: Evaluation of Macugen Treatment of Macular Edema Due to Branch RVO
Sponsor: Palmetto Retina Center, LLC; Pfizer; OSI Pharmaceuticals
Purpose: To evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO). We hypothesize that macular edema secondary to BRVO is mediated by VEGF 165 and that chronic suppression of VEGF 165 will successfully treat BRVO related macular edema
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Open Label, Treatment
Number of Patients: 30
Inclusion Criteria: Macular edema secondary to BRVO involving the foveal center in male or female patients at least 18 years of age; duration of BRVO macular edema less than 6 months prior to baseline visit; best-corrected ETDRS visual acuity 20/40-20/320 (Snellen equivalent) using the 4 meters testing method
Exclusion Criteria: Ocular conditions other than BRVO related macular edema such as significant cataract, diabetic retinopathy, AMD, glaucoma, uveitis, epiretinal membrane, vitreomacular traction or tumor; intraocular surgery within past 3 months
Information: jackwells@palmettoretina.com

UVEITIS

Study: VISUAL I: Efficacy and Safety of Adalimumab in Subjects With Active Uveitis
Sponsor: Abbott
Purpose: To compare the safety and efficacy of Adalimumab vs. Placebo in subjects with active uveitis
Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 250
Inclusion Criteria: Subject must have active disease at Baseline as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of maintenance therapy with oral prednisone >/= 10 mg/day (or oral corticosteroid equivalent): Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion; >/= 2+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria); >/= 2+ vitreous haze (National Eye Institute [NEI]/SUN criteria)
Exclusion Criteria: Subject with isolated anterior uveitis; subject with prior inadequate response to or intolerance to high-dose oral corticosteroids (equivalent of oral prednisone 1 mg/kg/day or 60 to 80 mg/day); subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus ( CMV ), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV)
Information: Beverly.Paperiello@abbott.com

Study: Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis
Sponsor: Lux Biosciences
Purpose: To assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior ocular segments
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 150
Inclusion Criteria: Active noninfectious uveitis involving the intermediate and/or posterior segment (ie, anterior + intermediate-, intermediate-, posterior- or panuveitis) in at least one eye as evidenced by a vitreous haze grade of at least 2+ at the baseline visit. Subjects who also have anterior segment involvement need not be excluded if otherwise qualified
Exclusion Criteria: Uveitis limited to only the anterior segment of the study eye; confirmed or suspected infectious uveitis in either eye, including but not limited to infectious uveitis due to tuberculosis, cytomegalovirus, Lyme disease, toxoplasmosis, Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, herpes zoster virus (HZV), and herpes simplex virus (HSV) or history of other ocular herpetic infection; Fuchs heterochromic iridocyclitis
Information: eddy.anglade@luxbio.com

Study: Pegaptanib Therapy in Uveitis
Sponsor: Wake Forest University
Purpose: To consider alternative forms of local (ocular) therapy for CME to triamcinolone (sub tenon and intraocular)
Design: Interventional, Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: 5
Inclusion Criteria: Demonstrable (FA and/or OCT) bilateral or unilateral CME associated with uveitis of greater than 3 months but less than 1 years duration that is documented by two independent qualified observers; best corrected VA between 20/40 and 20/200 as measured by the ETDRS chart attributable to CME in the study eye; patients may be receiving systemic therapy for the treatment of their intraocular inflammation or cystoid macular edema, or may have been treated for the cystoid macular edema in the past
Exclusion Criteria: Allergy to pegaptanib or any of its components; diabetic retinopathy, macular degeneration or any other ocular condition affecting the study eye that may cause vision loss or in the opinion of the study investigator would interfere with the evaluation of the efficacy of Macugen for the treatment of uveitis associated CME
Information: lcooke@wfubmc.edu

Study: The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease
Sponsor: National Eye Institute
Purpose: To examine the proteins of people with uveitis, or inflammation of the eyes
Design: Observational
Number of Patients: 300
Inclusion Criteria: Patients meet the criteria for entry into the MUST study and have been randomized to receive a steroid implant; those who are in other studies must participate in a study that permits the evaluation of specimens
Exclusion Criteria: Eligible participants who do not wish to donate their vitreous specimen or anterior chamber fluid, as appropriate, or blood sample or undergo a blood draw for the purposes of this research study
Information: prpl@mail.cc.nih.gov

Study: Optiquel(™) as Corticosteroid-sparing Therapy for Chronic Noninfectious Uveitis
Sponsor: National Eye Institute
Purpose: To develop new treatments for uveitis that are more effective and have fewer side effects
Design: interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 60
Inclusion Criteria: Participant has been diagnosed with non-infectious unilateral or bilateral uveitis for at least three months. Participants who were diagnosed more than a year prior to enrollment must have had a recurrence in ocular inflammation within the past year; articipant must be receiving a current treatment with prednisone between 20 to 40 mg/day (or an equipotent dose of an alternative corticosteroid). Participants who are on a regimen of no more than one anti-metabolite inhibitor at the time of randomization (e.g., azathioprine, methotrexate, mycophenolate) in addition to the prednisone may be enrolled and are allowed to continue the anti-metabolite
Exclusion Criteria: Participant has a non-iatrogenic immunodeficiency state (e.g., HIV infection or congenital immunodeficiency); participant had intra-ocular surgery or intraocular injection within three months prior to randomization; participant is expected to have an elective ocular surgery or intraocular injection during the study period
Information: prpl@mail.cc.nih.gov

Study: Safety and Efficacy of AIN457 in Noninfectious Uveitis
Sponsor: Novartis
Purpose: To test the efficacy and safety of AIN457 for patients with active uveitis that requires systemic immunosuppression
Design: Randomized, Parallel Assignment, Double-blind, Treatment
Number of Patients: 78
Inclusion Criteria: Intermediate uveitis, posterior uveitis, or panuveitis must be sufficiently severe that systemic immunosuppression is indicated
Exclusion Criteria: Active infection; weight must not be greater that 120 kg
Information: jayne.brown@emoryhealthcare. org

STUDIES WITH RESULTS

Study: AMDB1: Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration
Sponsor: National Eye Institute
Information: http://www.clinicaltrials.gov/ct2/show/Results NCT00436553

Study: Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization
Sponsor: Novartis
Information: http://www.clinicaltrials.gov/ct2/show/NCT00436553

NO LONGER ENROLLING

Study: Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy
Sponsor: Pfizer
Information: (800) 718-1021



Retinal Physician, Issue: June 2011