Article Date: 9/1/2011

Clinical Trial Update

Clinical Trial Update

DRY AMD

Study: Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
Sponsor: GlaxoSmithKline
Purpose: To determine the safety and efficacy of GSK933776 in the treatment of geographic atrophy secondary to age-related macular degeneration
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Doubleblind, Treatment
Number of Patients: 162
Inclusion Criteria: Evidence of AMD confirmed by the presence of at least 1 druse ≥ 125 μm diameter; well-demarcated GA due to AMD of total area 1.9-17 mm2 measured in the study eye; best-corrected visual acuity score of ≥ 55 letters (approximately 20/80 Snellen VA equivalent or better) in the study eye
Exclusion Criteria: Additional eye disease in the study eye that could compromise assessment of best-corrected visual acuity or imaging of the posterior pole; history of CNV in either eye; any previous treatment for AMD approved or investigational, with the exception of dietary supplements
Information: GSKClinicalSupportHD@gsk.com

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 of 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 AMD; 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
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

WET AMD

Study: 12 Week Patient Study in Neovascular Age-related Macular Degeneration
Sponsor: GlaxoSmithKline
Purpose: To investigate the safety and efficacy of a single dose regimen of pazopanib eye drop for neovascular AMD
Design: Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: 27
Inclusion Criteria: For each subject enrolled in the study, only one eye (study eye) will be treated, and eligibility criteria apply to the study eye. All of the following characteristics are required and must be confirmed by the central reading center: CNV caused by AMD that extends under the geometric center of the foveal avascular zone; center subfield thickness (inclusive of subretinal fluid) > 320 microns on OCT
Exclusion Criteria: Additional eye disease in the study eye that could compromise bestcorrected visual acuity (eg glaucoma with documented visual field loss, clinically significant diabetic retinopathy, ischemic optic neuropathy, infection or retinitis pigments); CNV in the study eye due to other causes unrelated to age-related macular degeneration; presence of retinal angiomatous proliferation (RAP) in the study eye, as determined by the investigator (confirmation by indocyanine green angiography is not required)
Information: GSKClinicalSupportHD@gsk.com

Study: Evaluation of AL-78898A in Exudative Age-Related Macular Degeneration
Sponsor: Alcon Research
Purpose: To assess whether AL-78898A, 5.25 mg is able to delay the need for reinjection in patients with exudative AMD
Design: Interventional, Randomized, Parallel Assignment, Double-blind, Treatment
Number of Patients: 110
Inclusion Criteria: Presence of active juxta- or subfoveal choroidal neovascularization secondary to AMD; central subfield macular thickness of >315 μm as assessed by SD-OCT; diagnosis of AMD within the previous 12 months with no fewer than 3 and no more than 12 Lucentis® or Avastin® treatments
Exclusion Criteria: History or current evidence of macular or retinal disease in the study eye other than exudative AMD; any evidence of fibrosis or scarring within the CNV lesion in the study eye; any evidence of vitreous hemorrhage in the study eye
Information: (888) 451-3937

Study: COMPASS: Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab
Sponsor: University of California, San Diego/Genentech
Purpose: To determine if patients treated early after diagnosis of wet age-related macular degeneration can return/maintain to their baseline pre-disease BCVA
Design: Intervention, Safety/Efficacy, Singlegroup Assignment, Open Label, Treatment
Number of Patients: 40
Inclusion Criteria: Naïve wet-AMD within 4 months of disease onset (for GALLEY patients) and within 3 months of disease onset for all others; patients that have lost > 5 letters from baseline best vision; BCVA 20/25-20/320
Exclusion Criteria: Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated; participation in another simultaneous medical investigation or trial which includes an intervention (Patients could be participating in a non-interventional study such as the GALLEY study); juxtafoveal and extrafoveal wet-AMD
Information: CJL015@ucsd.edu

Study: ESBA1008 Safety, Tolerability and Effects in Wet Age-related Macular Degeneration (AMD) Patients
Sponsor: Alcon Research
Purpose: To evaluate the safety, tolerability and effects of an investigational drug ESBA1008 for the treatment of exudative age-related macular degeneration
Design: Interventional, Randomized, Parallel Assignment, Double-blind, Treatment
Number of Patients: 90
Inclusion Criteria: Primary subfoveal choroidal neovascularization (CNV) secondary to AMD, including predominantly classic, minimally classic or occult lesions in study eye; a new diagnosis of exudative AMD or evidence of recent disease progression within the last 3 months in study eye
Exclusion Criteria: Study eye must not have been treated for wet AMD previously; study eye must not have any other ocular disease, condition, infection or recent surgery that would interfere with vision or examination of the back of the eye; study eye must not have uncontrolled glaucoma and/or must not be missing a lens
Information: (888) 451-3937

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 conerod 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 degeneration (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 (ie, 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 (ie, CNV previously diagnosed and treated with anti-vascular 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 of 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 sub-foveal focal laser photocoagulation involving the foveal center, History of vitrectomy, sub-macular 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 histo-plasmosis, 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 Treat ment 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
Information: (919) 456-5103

Study: Safety and Tolerability Study of AAV2-sFLT01 in Patients With Neovascular Age-Related Macular Degeneration (AMD)
Sponsor: Genzyme
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
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

DIABETIC MACULAR EDEMA

Study: VISTA DME: Study of Intravitreal Administration of VEGF Trap-Eye (BAY86-5321) in Patients With Diabetic Macular Edema
Sponsor: Regeneron/Bayer
Purpose: To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involvement
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 402
Inclusion Criteria: Adults ≥18 years with type 1 or 2 diabetes mellitus; decrease in vision determined to be primarily the result of DME in the study eye; BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
Exclusion Criteria: Laser photocoagulation (panretinal or macular) in the study eye within 90 days of day 1; previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1; previous treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc.) within 90 days of day 1; active proliferative diabetic retinopathy (PDR) in the study eye; uncontrolled diabetes mellitus; only 1 functional eye even if that eye is otherwise eligible for the study
Information: clinicaltrials@regeneron.com

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 photocoagula tion 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 photocoagulation 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 vitrec tomy 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 glaucoma requiring topical medications, infectious conjunctivitis, keratitis, or endophthalmitis of either eye; prior vitrectomy or intraocular lens placement, within 90 days of Day 0

Study: Near-Infrared Light Therapy for Diabetic Macular Edema: A Pilot Study
Sponsor: Medical College of Wisconsin
Purpose: To determine the effects of short term (3 month) near-infrared light (NIR) therapy on anatomic and functional abnormalities of diabetic macular edema as assessed by visual acuity, optical coherence tomography, multifocal electroretinography (mERG) and fundus bimicroscopy and to assess safety of short term near-infrared light therapy in eyes with diabetic macular edema
Design: Interventional, Non-randomized, Safety/Efficacy, Single-grroup Assignment, Open Label, Treatment
Number of Patients: 20
Inclusion Criteria: Diagnosis of diabetes mellitus (type 1 or type 2); any one of the following will be considered to be sufficient evidence that diabetes is present: current regular use of insulin for the treatment of diabetes; current regular use of oral anti-hyperglycemia agents for the treatment of diabetes; documented diabetes by ADA and/or WHO criteria (see Procedures Manual for definitions); at least one eye meets the study eye criteria; fellow eye meets criteria
Exclusion Criteria: Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant; subjects in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled; participation in an investigational trial within 30 days of NIR participation that involved treatment with any drug that has not received regulatory approval at the time of study entry
Information: hwhelan@mcw.edu

Study: Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)
Sponsor: Genentech/Michael J. Jumper
Purpose: To evaluate the safety and efficacy of intravitreally administered ranibizumab 0.5mg in subjects with Proliferative Diabetic Retinopathy experiencing post- Panretinal Photocoagulation (PRP) macular edema
Design: Interventional, Non-randomized, Safety/Efficacy, Parallel Assignment, Open Label Treatment
Number of Patients: 15
Information: jrose@westcoastretina.com
Inclusion Criteria: Pre-PRP protocol refraction, fluorescein angiography, and optical coherence tomography AND 7-14 day post-PRP OCT; previously untreated PDR patients with high risk characteristics who develop edema within 7-14 days post PRP therapy. This edema, determined by a masked investigator, will be characterized as either increased foveal thickness (>10% increase from pre-PRP foveal thickness), and/or increased macular volume on OCT (>10% increase from pre-PRP macular volume)
Exclusion Criteria: Pre-PRP clinically significant diabetic macular edema (CSME) that would make the patient eligible for macular laser prior to PRP; neovascularization of the iris or neovascular glaucoma; increased central foveal thickness for any other reason; concurrent macular diseases that could confound the results of this study; prior vitrectomy in the study eye; prior treatment with intravitreal injection including pegaptanib sodium, ranibizumab, bevacizumab or triamcinolone acetonide
Information: jrose@westcoastretina.com

STUDIES WITH RESULTS

Study: OT-551 Antioxidant Eye Drops to Treat Geographic Atrophy in Age-Related Macular Degeneration
Sponsor: Othera Pharmaceuticals/NEI
Information: http://clinicaltrials.gov/ct2/show/results/NCT00306488

Study: AMDB1: Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degen eration
Sponsor: National Eye Institute
Information: http://www.clinicaltrials.gov/ct2/show/ResultsNCT00436553

Study: SDME: Sirolums to Treat Diabetic Macular Edema
Sponsor: National Eye Institute
Information: http://www.clinicaltrials.gov/ct2/show/NCT00711490

NO LONGER ENROLLING

Study: Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Diabetic Macular Edema
Sponsor: Mount Sinai School of Medicine
Information: rojeoktay.kacmaz@mssm.edu



Retinal Physician, Issue: September 2011