Article Date: 10/1/2013

Clinical Trial Update

CLINICAL TRIAL UPDATE

DRY AMD

Study: NEAMD: Non-exudative Age-related

Macular Degeneration

Sponsor: Oregon Health and Science University

Purpose: To use OCT technology to compare how the retinal anatomy and blood flow differ within three severity groupings of nonexudative age-related macular degeneration

Design: Observational, Case Control, Prospective

Number of Patients: 20

Inclusion Criteria: Presence of mild, moderate or severe NEAMD; media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs; vision better than 20/200

Exclusion Criteria: Inability to maintain stable fixation for OCT imaging. A condition that, in the opinion of the investigator, would preclude participation in the study (eg, unstable medical status including blood pressure, cardiovascular disease, and glycemic control); a concurrent ocular pathology that may contribute to vision loss (eg, CNV, glaucoma, visually significant cataract, optic neuropathy, diabetic retinopathy, history of retinal surgery) or interfere with acquisition of high-quality images; blood pressure > 180/110

Information: (503) 494-3000

Study: I-TEAM: Intervention Trial in Early Age-related Macular Degeneration

Sponsor: Newtricious R&D BV

Purpose: To assess whether there is a change in visual function and status of the retina after a year of intervention in subjects with early signs of age-related macular degeneration

Design: Randomized, Efficacy, Parallel Assignment, Double-blind, Treatment

Number of Patients: 120

Inclusion Criteria: Many small drusen, or a few intermediate-sized (63-124 micrometres in diameter) drusen, or macular pigmentary changes

Exclusion Criteria: Ocular media opacity (severe cataract); history of active small bowel disease or resection; atrophic gastritis; hyperlipidemia (LDL >120 mg/dL or triglycerides >400 mg/dL)

Information: ian.j.murray@manchester.ac.uk

Study: Study on Visual Function Impairments in Dry Age-related Macular Degeneration

Sponsor: Duke University

Purpose: To submit enrollees to the visual function testing

Design: Observational, Prospective

Number of Patients: 190

Inclusion Criteria: Has been diagnosed with dry age-related macular degeneration stages 1-3

Exclusion Criteria: Presence of retinal pathology such as central geographic atrophy, hemorrhage or retinal fluid, and other macular pathology other than AMD

Information: (919) 684-9010

Study: SEATTLE: Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride (SEATTLE)

Sponsor: Acucela, Inc.

Purpose: To determine if emixustat hydrochloride (ACU-4429) reduces the rate of progression of geographic atrophy compared to placebo in subjects with dry age-related macular degeneration

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment

Number of Patients: 440

Inclusion Criteria: Clinical diagnosis of GA associated with AMD

Exclusion Criteria: Active CNV or presence of an active ocular disease; known serious allergy to the fluorescein sodium for injection in angiography; pre-specified laboratory abnormalities at screening; treatment with any investigational study drug within 30 days of screening or device (within 60 days of screening)

Information: clinicaltrials@acucela.com

Study: A Safety Study of CNTO 2476 in Patients With AMD

Sponsor: Janssen Research & Development

Purpose: To evaluate the safety and tolerability of CNTO 2476 administered subretinally

Design: Randomized, Safety/Efficacy, Single Group Assignment, Open Label, Treatment

Number of Patients: 56

Inclusion Criteria: Bilateral GA of the macula caused by AMD

Exclusion Criteria: Exudative AMD; evidence of other significant ophthalmologic disease; ocular hypertension; previous cell therapy other than blood components

Information: JNJ.CT@sylogent.com

Study: Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

Sponsor: Alimera

Purpose: To compare the safety and efficacy of Medidur FA treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 40

Inclusion Criteria: Bilateral GA secondary to AMD of ≥0.5 and ≤7 disc areas

Exclusion Criteria: GA secondary to any condition other than AMD in either eye; history of or current CNV or need for anti-angiogenic therapy; glaucoma or ocular hypertension

Information: lschulz@med.wayne.edu

Study: Study of Human Central Nervous System Stem Cells (HuCNS-SC) in

AMD Sponsor: StemCells, Inc.

Purpose: To investigate the safety and preliminary efficacy of unilateral subretinal transplantation of HuCNS-SC cells in subjects with geographic atrophy secondary to AMD

Design: Interventional, Safety/Efficacy, Single Group Assignment, Open Label, Treatment

Number of Patients: 16

Inclusion Criteria: Diagnosis of AMD with GA; only patients with a specific degree and extent of GA will be eligible

Exclusion Criteria: Prior vitreal or retinal surgery; glaucoma; atrophic macular disease of any other cause; diabetic retinopathy or DME

Information: kglocke@retinafoundation.org

DRY AMD

Study: Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry AMD Including GA

Sponsor: Pfizer

Purpose: To determine the safety and tolerability of multiple doses of RN6G in subjects with advanced dry, AMD including GA

Design: Randomized, Pharmacokinetics, Single Group, Double-blind, Treatment

Number of Patients: 24

Inclusion Criteria: Diagnosis of dry AMD including uni- or multi-focal GA without foveal involvement; BCVA of 20/50 or better

Exclusion Criteria: Ocular disease other than advanced AMD or GA in the study eye; history or diagnosis of exudative AMD, with subretinal or CNV lesions; medications known to be toxic to the lens, retina or optic nerve

Information: (800) 718-1021

Study: Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With GA Secondary to AMD

Sponsor: GlaxoSmithKline

Purpose: To determine the safety and efficacy of GSK933776 in the treatment of GA secondary to AMD

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 162

Inclusion Criteria: Evidence of AMD confirmed by the presence of at least 1 drusen ≥125 microns; well-demarcated GA due to AMD

Exclusion Criteria: Additional eye disease that could compromise assessment of BCVA or imaging of the posterior pole; history of CNV; previous treatment for AMD, with the exception of dietary supplements

Information: GSKClinicalSupportHD@gsk.com

Study: Safety and Tolerability of Subretinal Transplantation of hESC-derived RPE (MA09-hRPE) Cells in Patients With Advanced Dry AMD

Sponsor: Advanced Cell Technology

Purpose: To evaluate the effect of subretinal injection of human embryonic stem cell-derived RPE cells in patients with dry AMD and to perform exploratory evaluation of potential efficacy endpoints to be used in future studies of RPE cellular therapy

Design: Interventional, Safety, Single Group Assignment, Open Label

Number of Patients: 12

Inclusion Criteria: Advanced dry AMD with evidence of one or more areas of > 250 microns of GA involving the central fovea

Exclusion Criteria: Presence of active or inactive CNV; presence or history of other retinal vascular or degenerative disease other than AMD; history of optic neuropathy

Information: schwartz@jsei.ucla.edu

Study: Pharmacokinetics of CLG561 in Patients With Advanced Age-Related Macular Degeneration

Sponsor: Alcon Research

Purpose: To evaluate the safety, tolerability, and serum pharmacokinetics of CLG561 in subjects with advanced age-related macular degeneration

Design: Interventional, Nonrandomized, Parallel Assignment, Open Label, Basic Science

Number of Patients: 24

Inclusion Criteria: Diagnosis of age-related macular degeneration in study eye, as specified in protocol; poor visual acuity in study eye, as specified in protocol; willing to receive meningitis and pneumonia vaccinations at least 2 weeks prior to study treatment

Exclusion Criteria: Treatments to the study eye within 28 days prior to study treatment, as specified in protocol; any disease or medication expected to cause systemic or ocular immunosuppression

Information: alcon.medinfo@alcon.com

WET AMD

Study: ESBA1008 Microvolume Study

Sponsor: Alcon

Purpose: To demonstrate a treatment effect of ESBA1008 applied as microvolume injection or infusion on retinal function and morphology in subjects with exudative age-related macular degeneration

Design: interventional, Randomized, Efficacy, Parallel Assignment, Single-blind, Treatment

Number of Patients: 26

Inclusion Criteria: Age-related macular degeneration in the study eye; visual acuity within protocol-specified range

Exclusion Criteria: Any treatment for exudative age-related macular degeneration (AMD) other than vitamin supplements; any current or history of macular or retinal disease; any concurrent intraocular condition such as cataract or diabetic retinopathy that, in the opinion of the Investigator, could either require medical or surgical intervention during the course of the study to prevent or treat visual loss

Information: alcon.medinfo@alcon.com

Study: Pilot Study of X-82 in Patients With Wet AMD

Sponsor: Xcovery Vision, LLC/Tyrogenex

Purpose: To evaluate the safety and preliminary biologic activity/efficacy of X-82 in patients with wet Age-related Macular Degeneration

Design: Interventional, Safety/Efficacy, Single Group Assignment, Open Label, Treatment

Number of Patients: 20

Inclusion Criteria: Active choroidal neovascularization (CNV) associated with AMD, as evidenced on fluorescein angiography (FA) and OCT; no previous treatment with anti-VEGF therapy or prior anti-VEGF therapy with evidence of response to treatment and the need for additional treatment; Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA 20/32 to 20/320 in the study eye(s); adequate bone marrow function

Exclusion Criteria: Previous treatment with photodynamic therapy (PDT) within 4 months of screening in the study eye; CNV due to causes other than AMD; geographic atrophy involving the foveal center in the study eye; any retinal vascular disease or retinal degeneration other than AMD in the study eye

Information: brittanybrown@trialrunners.com

Study: Prospective Randomized Trial of Proton Beam Combined With Anti-VEGF Therapy for Exudative AMD

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: VA 20/40 to 20/400; lesion size <12 DA; submacular hemorrhage <75% of total lesion and not involving foveal center; submacular fibrosis <25% of total lesion

Exclusion Criteria: Previous treatment with photodynamic therapy or thermal laser; anti-VEGF therapy within 6 weeks; intravitreal or sub-Tenon’s Kenalog within 6 months

Information: (916) 734-6074

Study: NVAMD: Neovascular Age-related Macular Degeneration

Sponsor: Oregon Health and Science University

Purpose: To assess the utility of OCT angiography in the evaluation of NVAMD

Design: Observational, Case Control, Prospective

Number of Patients: 15

Inclusion Criteria: Presence of neovascular AMD confirmed by fluorescein dye leakage on angiogram or presence of at least one of the following on OCT: subretinal fluid, intraretinal fluid, or sub-retinal pigment epithelial fluid; treatment naïve group consists of individuals who have not received any treatment for neovascular AMD in the study eye; votive treatment group consists of individuals who have received treatment with an anti-VEGF agent (Avastin, Lucentis, Macugen, or Eylea) 6 weeks prior enrollment visit

Exclusion Criteria: Inability to maintain stable fixation for OCT imaging; significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant; a condition that, in the opinion of the investigator, would preclude participation in the study (eg, unstable medical status including blood pressure, cardiovascular disease, and glycemic control); blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible; prior macular laser treatment; Subretinal hemorrhage or fibrosis >50% of choroidal neovascular lesion; visual acuity 20/200 or worse; an ocular condition is present such that, in the opinion of the investigator, may alter the retinal anatomy (eg, epiretinal membrane); an ocular condition is present (other than neovascular AMD) that, in the opinion of the investigator, might affect or alter visual acuity during the course of the study (eg, vein occlusion, uveitis or other ocular inflammatory disease, etc.)

Information: (503) 494-3000

Study: Effects of Sildenafil on Choroidal Thickness in AMD

Sponsor: Duke University

Purpose: To compare choroidal thickness changes after a single-dose sildenafil treatment in AMD patients compared with age-matched controls

Design: Interventional, Nonrandomized, Efficacy, Single Group, Open Label

Number of Patients: 80

Inclusion Criteria: Has been diagnosed with AMD

Exclusion Criteria: History of previous photodynamic therapy (PDT), intravitreal corticosteroid injection, macular focal laser photocoagulation, panretinal photocoagulation, ocular ionizing irradiation, transpupillary thermotherapy, or any vitreoretinal surgeries

Information: (919) 797-9111

Study: RE-VIEW: Study to Assess Best Corrected Visual Acuity in Patients With Neovascular AMD Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection)

Sponsor: Regeneron

Purpose: To evaluate the efficacy and safety of Intravitreal Aflibercept Injection (IAI) administered over 2 years, and to provide clinical information from the first year in the trial evaluating the adverse effects, if any, on the corneal endothelium following administration of IAI

Design: Interventional, Safety/Efficacy, Single Group, Open Label, Treatment

Number of Patients: 150

Inclusion Criteria: Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye; the CNV area must be at least 50% of total lesion size

Exclusion Criteria: Exudative AMD in the fellow eye; corneal endothelial measures as judged by an independent reading center; any prior use of intraocular anti-VEGF treatment for neovascular AMD in either eye

Information: clinicaltrials@regeneron.com

Study: ATLAS: Repeated Eye Injections of Aflibercept for Treatment of Wet AMD

Sponsor: Brian Burke, MPH/Regeneron

Purpose: To evaluate the visual outcome and number of injections required during an OCT- guided treat and extend regimen with intravitreal aflibercept for treatment of subfoveal neovascular AMD

Design: Interventional, Nonrandomized, Parallel Assignment, Open Label, Treatment

Number of Patients: 40

Inclusion Criteria: Only one eye for each patient demonstrating a pre-treatment acuity of 20/25 - 20/320 is eligible; patients cannot have concurrent progressive retinal disease

Exclusion Criteria: Prior treatment for NVAMD in the study eye; prior experimental treatment of NVAMD; prior treatment with systemic anti-VEGF agents; prior treatment with verteporfin

Information: research@midatlanticretina.com

Study: Genetic Load and Phenotype in Aggressive AMD (RPED Genetics)

Sponsor: Sequenom, Inc.

Purpose: To examine cheek cell samples to determine if there is a correlation between genotype (DNA markers) and phenotype (the type of AMD the patient has)

Design: Observational, Cohort, Prospective

Number of Patients: 100

Inclusion Criteria: Subject agrees to provide two buccal swabs in accordance with this protocol

Exclusion Criteria: Previous sample donation under this protocol; presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss which have been present prior to age 50

Information: (415) 923-3482

Study: Efficacy and Safety of Squalamine Lactate Eye Drops in Subjects With Neovascular (Wet) AMD

Sponsor: Ohr Pharmaceuticals, Inc.

Purpose: To evaluate the safety and efficacy of topical squalamine lactate eye drops in treating patients with neovascular AMD

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 120

Inclusion Criteria: A diagnosis of CNV secondary to AMD with total lesion area ≤ 12 disc areas with CNV affecting at least 50% of the total lesion area confirmed by FA

Exclusion Criteria: Neovascularization secondary to any condition other than AMD in the study eye; blood occupying greater than 50% of the AMD lesion

Information: ifaraporewala@ohrpharmaceutical.com

Study: T-REX: Treat and Extend Treatment With 0.5mg Ranibizumab vs Monthly Treatment With 0.5mg Ranibizumab

Sponsor: Charles C. Wykoff, MD, PhD/Genentech

Purpose: To maintain an exudation-free macula with the fewest number of office visits, tests and injections

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Open Label, Treatment

Number of Patients: 60

Inclusion Criteria: Any CNVM lesion secondary to AMD; BCVA in the study eye between 20/32 and 20/400; the total area of subretinal hemorrhage and fibrosis must comprise less than 50% of the total lesion

Exclusion Criteria: Subretinal hemorrhage in the study involving the center of the fovea

Information: karri.schuetzle@houstonretina.com

Study: Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in Retinovascular Imaging (PVOCT)

Sponsor: University of California, San Francisco

Purpose: To determine whether phase variance optical coherence tomography (PVOCT), a software-based OCT image processing technology, can be used to generate angiographic images of the retinochoroidal vasculature that are comparable to those produced by fluorescein angiography

Design: Observational, Cohort, Prospective

Number of Patients: 78

Exclusion Criteria: Any patients with ocular media opacities which prevent clear evaluation of the fundus by either FA or OCT

Information: smcclint@gmail.com

Study: Association of Macular Pigment Optical Density (MPOD) and Genetic Variants in Complement Factor H in Subjects With Choroidal Neovascular (CNV)

Sponsor: Sequenom, Inc.

Purpose: To determine if there is an association between genetics, MPOD and the risk of progression to wet AMD

Design: Observational, Cohort, Prospective

Number of Patients: 150

Inclusion Criteria: Subject is diagnosed with either CNV, dry AMD or is an age-matched control; self-reported as non-Hispanic Caucasian

Exclusion Criteria: Previous donation

Information: jmcavinue@morriseyegroup.com

Study: Nexus: Efficacy and Safety Study of iSONEP With and Without

Lucentis/Avastin to Treat AMD

Sponsor: Lpath, Inc./Pfizer

Purpose: To determine the safety and efficacy of 4 monthly injections of iSONEP given alone or in combination with Lucentis or Avastin in subjects with wet AMD

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind

Number of Patients: 160

Inclusion Criteria: Subjects who have received 3-10 IVT injections of Lucentis or Avastin within 12 months prior to screening; active subfoveal CNV secondary to AMD

Exclusion Criteria: Most recent IVT injection of Lucentis or Avastin <28 days and >65 days prior to screening; previous PDT or Macugen at any time point; focal thermal laser or grid laser within 3 months prior to Day 0

Information: info@lpath.com

Study: Study of the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Injection in Subjects With Exudative Macular Degeneration Previously Treated With Ranibizumab or Bevacizumab

Sponsor: Cleveland Clinic/Regeneron

Purpose: To examine the use of Aflibercept in patients with exudative macular degeneration requiring intravitreal injections

Design: Observational, Case-only, Prospective

Number of Patients: 25

Inclusion Criteria: Active primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by historical OCTs and angiograms

Exclusion Criteria: Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins

Information: singhr@ccf.org

Study: Safety and Efficacy of Intravitreal LFG316 in Wet AMD

Sponsor: Novartis

Purpose: To assess the safety and efficacy of LFG316 in patients with AMD

Design: Randomized, Parallel Assignment, Single-blind, Treatment

Number of Patients: 57

Inclusion Criteria: BCVA of 60 letters or less in the study eye; an active CNV membrane attributable to neovascular AMD

Exclusion Criteria: History of recurrent non-response to anti-VEGF therapy; retinal disease other than AMD; CNV not due to AMD

Information: (862) 778-8300

Study: Study of Bimonthly VEGF Trap-Eye Compared to As-needed Administration or Other Therapy for Exudative AMD

Sponsor: Stanford University

Purpose: To determine whether patients who have switched from ranibizumab to VEGF Trap- Eye have comparable results

Design: Observational, Cohort, Prospective

Number of Patients: 590

Inclusion Criteria: Established diagnois of exidative AMD who have been switched from ranibizumab to VEGF Trap-Eye

Exclusion Criteria: Previous or concurrent history of treatment of other retinal diseases with agents other than ranibizumab

Information: (650) 723-6995

Study: Addition of 20 mg/Day Zeaxanthin to Triple Therapy Treatment Options for AMD

Sponsor: The Retina Center of St. Louis County, P.C./ZeaVision, Inc.

Purpose: To evaluate whether 20 mg per day of oral zeaxanthin as a supplement to patients with CNV and exudative AMD undergoing combination therapy with bevacizumab, dexamethasone and PDT laser photocoagulation improves outcomes

Design: Observational, Case Control, Retrospective

Number of Patients: 200

Inclusion Criteria: Subjects must have AMD with a CNV membrane either classic or occult in at least one eye; preoperative BCVA equal to or greater than 19 letters

Exclusion Criteria: Retinal disease not AMD

Information: rjolk@retina-stl.com

Study: Evaluation of AGN-150998 in Exudative AMD

Sponsor: Allergan

Purpose: To assess the safety of AGN- 150998 administered as an intravitreal injection to patients with exudative AMD

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment

Number of Patients: 200

Inclusion Criteria: AMD; BCVA between 20/40 and 20/320

Exclusion Criteria: Nearsightedness of 8 D or more; history of or current glaucoma in the study eye; cataract surgery or Lasik within the last 3 months

Information: clinicaltrials@allergan.com

Study: Study of Dark Adaptation in AMD

Sponsor: National Eye Institute

Purpose: To evaluate the effectiveness of using a dark adaptation protocol to identify and monitor early to middle dry AMD

Design: Observational, Prospective

Number of Patients: 200

Inclusion Criteria: Group 0: No large drusen or advanced AMD; Group 1: At least one large drusen in the study eye and no large drusen or advanced AMD in the fellow eye; Group 2: Bilateral large drusen with or without RPE hypo/hyperpigmentary changes; Group 3: At least one large drusen in the study eye and advanced AMD in the fellow eye

Exclusion Criteria: Advanced AMD

Information: prpl@mail.cc.nih.gov

Study: CFH&AMD: Complement Factor H Haplotypes and Smoking in AMD

Sponsor: Department of Veterans Affairs

Purpose: To test the hypothesis that smoking increases AMD by increasing complement activation and that this is positively correlated with known disease variations in the CFH gene

Design: Observational, Cohort, Prospective

Number of Patients: 300

Exclusion Criteria: Ocular diseases that might simulate AMD or preclude its diagnosis

Information: rohrer@musc.edu

Study: Proton Radiation Therapy for Macular Degeneration

Sponsor: University of Florida

Purpose: To determine if proton radiation therapy can provide effective and safe treatment for subfoveal neovascularization membrane

Design: Inteventional, Safety, Single Group, Open Label, Treatment

Number of Patients: 10

Inclusion Criteria: Patients with subfoveal neovascular membranes identified on fluorescein angiography; visual acuity (best corrected vision) 20/200 or worse in affected eye; patients must have had prior treatment for macular degeneration with Avastin (bevacizumab) or Lucentis (ranibizumab)

Exclusion Criteria: History of diabetes

Information: (877) 686-6009

Study: A Phase 3 Safety and Efficacy Study of Fovista™ (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy

Sponsor: Ophthotech Corp.

Purpose: To evaluate the safety and efficacy of intravitreal administration of Fovista™ administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment

Number of Patients: 622

Inclusion Criteria: Subfoveal choroidal neovascularization (CNV) due to AMD with some classic component

Exclusion Criteria: Prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals; any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids); any intraocular surgery or thermal laser within three (3) months of trial entry; any prior thermal laser in the macular region, regardless of indication; subjects with subfoveal scar or subfoveal atrophy are excluded; diabetes mellitus

Information: Karen.Lewis@ophthotech.com

DIABETIC MACULAR EDEMA

Study: Nepafenac Once Daily for Macular Edema

Sponsor: Alcon

Purpose: To demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic subjects following cataract surgery

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment

Number of Patients: 590

Inclusion Criteria: Planned cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens; history of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR) (mild, moderate, or severe) in the study eye; BCVA of 73 letters or worse in the study eye with expectation of improvement after surgery

Exclusion Criteria: Pre-existing macular edema in the study eye; history in the study eye of retinal detachment, wet age-related macular degeneration, chronic or recurrent inflammatory eye disease, or prior procedures; planned cataract surgery in the fellow eye prior to the Day 90 postoperative study visit or through study exit; planned multiple procedures for the study eye during the cataract/intraocular lens

Information: alcon.medinfo@alcon.com

Study: Dextromethorphan for Diabetic Macular Edema

Sponsor: National Eye Institute

Purpose: To see if dextromethorphan can help treat diabetic macular edema

Design: Interventional, Safety/Efficacy, Single Group, Open Label, Treatment

Number of Patients: 8

Inclusion Criteria: BCVA ETDRS score of 34 letters or better (i.e., 20/200 or better) Definite retinal thickening due to diabetic macular edema based on clinical examination that is not refractory to further therapy

Exclusion Criteria: An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (eg, foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non-retinal condition); an ocular condition is present

Information: meg.gordon@nih.gov

Study: ROTATE: Ranibizumab For Persistent Diabetic Macular Edema After Bevacizumab

Sponsor: Southeast Retina Center, Georgia/Genentech

Purpose: To determine the safety and efficacy of intravitreally administered 0.3mg ranibizumab in subjects with persistent Diabetic Macular Edema (DME) after recent and frequent bevacizumab (at least 2 bevacizumab intravitreal injections within 2 months prior to enrollment and at least 6 bevacizumab injections within 9 months of enrollment)

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Open Label, Treatment

Number of Patients: 30

Inclusion Criteria: Central-involved DME in study eye (OCT CSF >=275um on Heidelberg Spectralis spectral domain OCT with evidence of intraretinal or subretinal fluid or cysts); definite retinal thickening due to diabetic macular edema involving the center of the macula

Exclusion Criteria: Known allergy to ranibizumab; acute cardiovascular event requiring hospitalization within the past 3 months; systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization or anticipated use during study; macular edema is considered to be due to a cause other than DME

Information: dmarcus@southeastretina.com

Study: OPERA: Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl

Sponsor: Cleveland Clinic/Allergan

Purpose: To examine the use of the dexamethasone implant (Ozurdex) in patients with diabetic macular edema associated with an epiretinal or preretinal membrane requiring surgical intervention

Design: Interventional, Single Group Assignment, Open Label, Treatment

Number of Patients: 30

Inclusion Criteria: Patients who are undergoing pars plana vitrectomy for: epiretinal membrane/vitreomacular traction or diabetic macular edema; patients with macular edema as measured by OCT (at least 250 µm central subfoveal thickness)

Exclusion Criteria: History of active inflammatory eye disease (uveitis) (within 3 months); history of ocular malignancy and/or ocular/orbital irradiation; history of recent retinal vein occlusion (within 6 months)

Information: srivass2@ccf.org

Study: Safety and Effectiveness of Ozurdex Steroid Implants for DME After Vitrectomy Surgery

Sponsor: Lahey Clinc

Purpose: To assess the safety and efficacy of Ozurdex after vitrectomy

Design: Randomized, Safety/Efficacy, Singlegroup Assignment, Double-blind, Treatment

Number of Patients: 15

Inclusion Criteria: Patients with DME secondary to diabetes mellitus involving the center of the macula OCT thickness is > 300 µm with intraretinal cystic edema; BCVA between 20/40 to 20/400; patient had vitrectomy surgery

Exclusion Criteria: Patient unlikely to benefit from intravitreal Ozurdex due to macular ischemia, atrophy, or other condition; patient with history of steroid response with IOP >35 mm Hg or requirement to be on > 2 glaucoma medications following previous steroid injection

Information: avon.p.stewart@lahey.org

Study: CDDR: Computer Detection of Diabetic Retinopathy Compared to

Clinical Examination

Sponsor: IDx LLC

Purpose: To determine whether computer detection of the severity of diabetic retinopathy including the presence of clinically significant macular edema is not inferior to the detection using a dilated eye examination by a Boardcertified ophthalmologist

Design: Observational, Case-only, Prospective

Number of Patients: 600

Inclusion Criteria: No history of any other retinal vascular disease, glaucoma, or other disease that may affect the appearance of the retina or optic disc (refractive error and ocular surface disease are allowed); other than cataract surgery

Exclusion Criteria: A history of retinal vascular disease other than due to diabetic retinopathy, glaucoma, or other disease that may affect the appearance of the retina or optic disc; previous intraocular surgery other than cataract; previous laser to the retina

Information: (713) 559-5200

Study: Ranibizumab and Bevacizumab for Diabetic Macular Edema

Sponsor: National Eye Institute

Purpose: To compare the effectiveness of ranibizumab and bevacizumab injections for diabetic macular edema

Design: Interventional, Randomized, Safety/Efficacy, Crossover Assignment, Doubleblind, Treatment Number of Subjects: 60

Inclusion Criteria: Eye has a BCVA ETDRS score between 20/32 and 20/400; eye has definite retinal thickening or cystic changes 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

Exclusion Criteria: Eye has an ocular condition present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (eg, foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non-retinal condition)

Information: wileyhe@mail.nih.gov

Study: Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

Sponsor: Retina Macula Institute/Allergan

Purpose: To test the efficacy of a 0.7-mg intravitreal dexamethasone implant on macular leakage and VA for patients with recalcitrant DME

Design: Interventional, Randomized, Efficacy, Parallel Assignment, Single-blind, Treatment

Number of Patients: 20

Inclusion Criteria: Presence of NPDR or PDR as confirmed by FA; prior treatment with ≥ 2 intravitreal anti-VEGF injections but no treatment in last 4 weeks; < 0.1 Log OCT decrease in macular edema on high resolution OCT between initial visit and following treatment with ≥ 2 anti-VEGF injections

Exclusion Criteria: Injection of steroid medication within prior 3 months; evidence of significant GA on fluorescein angiography in the opinion of the treating physician; concurrent ocular disease that would limit visual acuity; prior vitrectomy surgery; use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to day 1; known history of IOP elevation in response to steroid treatment in either eye that resulted in any of the following: a) = 10 mm Hg increase in IOP in response to steroid injection, or b) IOP = 25 mm Hg and required 2 or more anti-glaucoma medications to keep IOP below 21 mm Hg

Information: gina.kim@retinamaculainstitute.com

Study: DAVE: Efficacy and Safety Trial of Intravitreal Injections Combined With PRP for the Treatment of CSME Secondary to Diabetes Mellitus

Sponsor: Genentech/Greater Houston Retina

Purpose: To study the efficacy and safety of ranibizumab injection monotherapy verses a duel therapy of 0.5 mg ranibizumab combined with ultrawide, 200° field angiography guided panretinal photocoagulation in patients with CSME-CI secondary to diabetes mellitus

Design: Interventional, Randomized, Safety/Efficacy, Single Group, Open Label, Treatment

Number of Patients: 40

Inclusion Criteria: BCVA of 20/32 to 20/200; high-definition OCT central thickness measurement of ≥ 300µm; decrease in VA determined to be the result of DME

Exclusion Criteria: Prior ocular treatment; history of vitrectomy surgery in the study eye; any panretinal photocoagulation in the study eye; prior treatment with intraocular or subconjunctival steroids in the study eye; Any concurrent intraocular condition in the study eye (eg, cataract or age related macular degeneration) that, in the opinion of the investigator, could require medical or surgical intervention during the 12-month study period to prevent or treat visual loss that might result from that condition; or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period

Information: dmbmd@houstonretina.com

Study: Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema

Sponsor: Retina Vitreous Associates of Florida/Genentech

Purpose: To determine whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than ranibizumab injections into the eye less frequently

Design: Randomized, Safety/Efficacy, Parallel Assignment, Open Label, Treatment

Number of Patients: 20

Inclusion Criteria: Patients will have met standard, accepted diagnostic criteria for diabetes and will be currently treated with at least one systemic antihyperglycemic or insulin medication; BCVA less than or equal to 20/40; central foveal thickness of >300 µm

Exclusion Criteria: Intraocular surgery less than 6 months ago; ERM of clinical significance; prior vitrectomy; uncontrolled glaucoma; Prior vitrectomy; uncontrolled glaucoma; macular or peripheral laser within 90 Days from Day 0 injection; intravitreal steroid injection within 90 days from Day 0 injection; intravitreal or systemic anti-VEGF within 30 days from Day 0 injection

Information: (727) 323-0077

Study: GEM: Phase I Dose Escalation Safety Study of RetinoStat in Advanced AMD

Sponsor: Oxford BioMedica

Purpose: To examine the safety of an experimental gene transfer agent, RetinoStat, designed to treat neovascular AMD

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

Exclusion Criteria: Significant ocular abnormalities that prevent retinal assessment; treatment with steroids within three months of screening; treatment with anti-VEGF therapy within one month of screening

Information: pcampo@jhmi.edu

Study: A Safety and Efficacy Study of Oral Danazol (a Previously Approved Drug)in the Treatment of Diabetic Macular Edema

Sponsor: Ampio Pharmaceuticals

Purpose: To evaluate the efficacy of ultra low dose danazol (Optina) for the treatment of diabetic macular edema versus placebo

Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment

Number of Patients: 450

Inclusion Criteria: Stable diabetic and metabolic control (no major changes in diabetic or lipid reducing medications for 3 months prior to start of this study as determined by the Investigator)

Exclusion Criteria: Known allergy to any danazol (Cyclomen or Danocrine) or any other non-medicinal component of the danazol test drug (cornstarch, lactose, magnesium stearate, gelatin, and talc); unstable cardiovascular disease or a history of significant heart disease (including unstable angina, acute coronary syndrome, myocardial infarction, or history of coronary revascularization procedure) within 6 months before randomization; a nocular condition is present such that, in the opinion of the Investigator, VA would not improve from resolution of macular edema (eg, foveal atrophy, closure of juxafoveal capillaries, dense subfoveal hard exudates); history of panretinal scatter photocoagulation (PRP) within 4 months prior to randomization

Information: hloose@ampiopharma.com



Retinal Physician, Volume: 10 , Issue: October 2013, page(s): 70 - 78