Article Date: 11/1/2010

Clinical Trial Update

Clinical Trial Update

DRY AMD

Study: Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy
Sponsor: Pfizer
Purpose: To determine the safety and tolerability of multiple doses of RN6G in subjects with advanced dry, age-related macular degeneration including geographic atrophy.
Design: Randomized, Single-group Assignment, Double-blind, Treatment
Number of Patients: 32
Inclusion Criteria: Diagnosis of dry AMD including uni- or multi-focal geographic atrophy without foveal involvement; BCVA of 20/50 or better in the study eye.
Exclusion Criteria: Evidence of ocular disease other than advanced AMD or GA in the study eye; history or diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions in the study eye; presence of disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous, immune, or gastrointestinal system.
Information: (800) 718-1021

Study: COMPLETE: Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD)
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 Re lated Macular Degeneration
Sponsor: Graham Merry, MD
Information: (865) 483-6399

Study: Sirolimus to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration
Sponsor: National Eye Institute
Information: (800) 411-1222

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: 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

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: 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: Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration
Sponsor: Allergan
Purpose: To evaluate the safety and efficacy of dexamethasone (Ozurdex) as adjunctive therapy to ranibizumab (Lucentis) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to AMD
Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 280
Inclusion Criteria: Received at least 2 and no more than 3 monthly Lucentis or Avastin injections; last Lucentis or Avastin was injected approximately 4 weeks prior to screening; visual acuity between 20/320 and 20/40
Exclusion Criteria: Active ocular infection; contraindication to pupil dilation in either eye; surgery including cataract surgery and/or laser of any type within 3 months
Information: clinicaltrials@allergan.com

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 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 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)
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: The Efficacy of Oral Everolimus in Patients With Neovascular AMD
Sponsor: Novartis
Purpose: To assess the safety and efficacy of Everolimus (RAD001) alone or in combination with Lucentis in patients with neovascular AMD.
Design: Randomized, Parallel Assignment, Double-blind, Treatment.
Number of Patients: 35
Inclusion Criteria: Patients with neovascular AMD; best-corrected visual acuity of 20/40 or worse in study eye; patients with predominantly classic, minimally classic, or occult choroidal neovascularization in the macula of one eye (the study eye) who have had an inadequate response to VEGF inhibitors in the study eye. Inadequate response is defined as a gain of less than one line of visual acuity and persistent macular edema (central subfield thickness ≥300 microns, measured by OCT) despite a minimum of 3 treatments with Lucentis or Avastin.
Exclusion Criteria: Any concurrent ocular condition in the study eye that may result in substantial change in vision during the study; Uncontrolled medical conditions such as cancer, angina, diabetes, viral or fungal infections, impaired lung function, history of stroke; Patients who have macular edema in the study eye that, in the judgment of the investigator, is unlikely to respond to treatment. Examples of features that may guide the investigator's judgment about unresponsiveness are large regions of geographic atrophy, retinal angiomatous proliferation, or large regions of subretinal fibrosis. The presence of one of these features excludes a patient only if the investigator judges the study eye to have irreversible macular edema.
Information: +41-61-324-1111

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 re-treatment; 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: WALTZ: Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination
Sponsor: Alcon Research
Purpose: To evaluate the safety, tolerability, and effects of an investigational drug called AL-39324 for the treatment of wet AMD.
Design: Randomized, Active Control, Safety/ Efficacy, Parallel Assignment, Double-blind, Treatment.
Number of Patients: 42
Inclusion Criteria: Must have a primary diagnosis of CNV secondary to AMD lesion must be no larger than 30 mm2; must have edema measuring at least 340 μm; must have a visual score between 73 and 34 letters; must be able to have clear picture taken of the back of the eye.
Exclusion Criteria: The study eye must not have been treated for wet AMD previously; the 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; the study eye must not have uncontrolled glaucoma; the study eye must not be missing a lens; must not be taking any medication that is toxic to the lens.
Information: (888) 451-3937

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 subretinal 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 interven tion 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 AMD
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 sub-foveal CNV secondary to AMD.
Design: Randomized, Active Control, Safety/ Efficacy Study, Parallel Assignment, Double-blind, Treatment.
Number of Patients: 444
Inclusion Criteria: Subfoveal choroidal neovascularization 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, MI 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 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 AMD
Sponsor: Genzyme
Purpose: To examine the safety and tolerability of an experimental gene transfer agent, AAV2-sFLT01, in patients with neovascular 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: A Study of Intravitreal Injections of 2.0 mg Ranibizumab in Subjects With Chronic Fluid On OCT Post Multiple Injections With Ranibizumab (Super-dose Anti-VEgf SAVE Trial)
Sponsor: Greater Houston Retina Center
Information: Karri.Shuetzle@houstonretina.com

Study: MONET: Phase II Open-label Multicenter Study For Age Related Macular Degeneration Comparing An Investigational Drug PF-04523655 Versus Lucentis In The Treatment Of Subjects With CNV
Sponsor: Pfizer/Quark Pharmaceuticals, Inc.
Information: (800) 718-1021

Study: Study of Intravitreal Microplasmin in Relieving Vitreo-Macular Adhesion in Neovascular AMD
Sponsor: University of California–Los Angeles/ThomboGenics
Information: ostrick@jsei.ucla.edu

Study: A Phase 1 Dose Escalation Study of PF-04523655 (REDD14NP) In Subjects With CNV Secondary to Wet AMD
Sponsor: Pfizer/Quark Pharmaceuticals, Inc.
Information: (800) 718-1021

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 Study of Ranibizumab Administered Monthly or on an As-Needed Basis in Patients With Subfoveal Neovascular AMD
Sponsor: Genentech
Purpose: To study the efficacy and safety of ranibizumab injection administered intravitreally to patients with CNV secondary to AMD.
Design: Treatment, Randomized, Double-blind (Subject, Investigator), Active Control, Parallel Assignment.
Number of Patients: 1100
Inclusion Criteria: CNV lesions with classic CNV component, occult CNV, or with some classic CNV component are permissible.
Exclusion Criteria: History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye; prior treatment with Visudyne, external-beam radiation therapy, or transpupillary therapy in the study eye.
Information: lane.hayley@gene.com

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: Detection of Neutralizing Antibodies in Patients Treated With Bevacizumab or Ranibizumab
Sponsor: National Eye Institute
Information: prpl@mail.cc.nih.gov

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

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

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 photocoagulation or tufts of NVE <1 disc area with no vitreous hemorrhage.
Information: jdenton2@jhmi.edu

Study: Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema
Sponsor: Novartis Pharmaceuticals
Purpose: To assess the efficacy of oral aliskiren (Tekturna) as a therapy for DME.
Design: Treatment, Randomized, Double-blind (Subject, Caregiver, Investigator), Parallel Assignment.
Number of Patients: 110
Exclusion Criteria: Recent intraocular surgery in the study eye (eg, cataract surgery in the last six months); recent photocoagulation in the study eye; recent treatment with Avastin, Lucentis or intravitreal corticosteroids in the study eye.
Information: (862) 778-8300

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: 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.
Information: (800) 451-3937

Study: Pilot Study for the Evaluation of Intravitreal Infliximab in Treatment of DME
Sponsor: Mount Sinai School of Medicine
Information: roje-oktay.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

Study: Sirolimus to Treat DME
Sponsor: National Eye Institute
Information: (800) 411-1222

Study: DEGAS: Prospective, Randomized, Multi-Center, Comparator Study Evaluating Efficacy and Safety of PF-04523655 vs Laser in Subjects with DME
Sponsor: Pfizer
Information: (800) 718-1021

RETINAL VEIN OCCLUSION

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.
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: Impact of Lucentis on Psychological Morbidity in Patients With RVO
Sponsor: Retina Associates of Cleveland, Inc./ Genentech
Purpose: To study the impact of intravitreally administered ranibizumab treatment on vision-related functioning and emotional well-being in subjects with central or branch RVO.
Design: Treatment, Nonrandomized, Open-label, Parallel Assignment, Efficacy Study.
Number of Patients: 45
Inclusion Criteria: Evidence of CRVO, defined as documented retinal hemorrhage into all four quadrants with dilated veins, or BRVO, as documented on clinical exam.
Exclusion Criteria: Acute illness or cognitive or other impairment that, in the opinion of the investigator, would interfere with study requirements; concurrent ocular conditions likely to significantly compromise vision and contribute the macular compromise.
Information: retina@retina-assoc.com

Study: RELATE: Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions
Sponsor: Johns Hopkins University/Genentech
Purpose: Evaluate the safety and tolerability of intraocular injections of 0.5 or 2.0 mg of ranibizumab in patients with macular edema due to RVO.
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.
Exclusion Criteria: Scatter laser photocoagulation or macular photocoagulation within 3 mo. 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 four months of study.
Information: ghafiz@jhmi.edu

Study: FAVOR: Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina
Sponsor: Alimera Sciences
Info: 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.
Information: (919) 684-4458

Study: Effectiveness and Safety of Niacin and a Topical Steroid to Treat RVO
Sponsor: Palo Alto Medical Foundation
Information: gaynonM@pamf.org

Study: Evaluation of Macugen Treatment of Macular Edema Due to Branch RVO
Sponsor: Palmetto Retina Center, LLC; Pfizer; OSI Pharmaceuticals
Information: jackwells@palmettoretina.com

Study: Fluocinolone Acetonide Implant for RVO
Sponsor: Duke University; Bausch + Lomb
Information: (919) 684-4458

Study: Intravitreal Ranibizumab Treatment of CRVO With Macular Edema
Sponsor: Vitreous-Retina Macula Consultants of New York/Genentech
Information: (212) 452-6965



Retinal Physician, Issue: November 2010