CLINICAL TRIAL UPDATE

► 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

A 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

► Study: Effect of Omega-3-fatty Acids on Blood Levels Omega-3 Fatty Acids in Patients With AMD
Sponsor: Physician Recommended Nutriceuticals/Wills Eye
Purpose: To assess the effect of omega-3-fatty acids on blood levels omega-3 fatty acids in patients with AMD
Design: Interventional, Randomized, Efficacy, Parallel Assignment, Open Label, Treatment
Number of Patients: 100
Inclusion Criteria: AREDS category 3 or 4
Exclusion Criteria: Patients with a known fish allergy; patients currently taking supplementation with omega-3 fatty acids and have an omega-3 index of greater than 4%
Information: research@midatlanticretina.com

► Study: Sirolimus for Advanced Age-Related Macular Degeneration
Sponsor: National Eye Institute
Purpose: To determine if sirolimus can help prevent vision loss in people with GA
Design: Interventional, Randomized, Safety/Efficacy, Single Group Assignment, Open Label, Treatment
Number of Patients: 15
Inclusion Criteria: Participant must have at least one large druse (greater than or equal to 125 microns) in each eye; participants must not have any evidence or history of exudative disease related to AMD in either eye as determined by a recent FA performed within 4 months of study; steady fixation in both eyes in the foveal or parafoveal area and media clear enough for good quality photographs
Exclusion Criteria: Evidence of disease other than AMD that may confound the outcome; history of macular laser or PDT; intravitreal injection of anti-VEGF agent for exudative AMD at any point; received an intravitreal injection of any other agent within four months prior to enrollment; prior vitrectomy
Information: shimelk@nei.nih.gov

► 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- ormulti-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 of total area 1.9-17 mm²; BCVA score of ≥55 letters
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 Sub-retinal 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 (as defined in the AREDS study) involving the central fovea; no evidence of current or prior CNV
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: Efficacy and Safety Study of MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration
Sponsor: MacuCLEAR, Inc.
Purpose: To assess the efficacy, safety, and tolerability of MC-1101 in patients with dry AMD
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind, Treatment
Number of Patients: 60
Inclusion Criteria: Better than 20/80 ETDRS best corrected visual acuity;mild to moderate nonexudative AMD (AMD steps 3 through 8 on Age-Related Eye Disease Study (AREDS) Report No. 17 grading scale)
Exclusion Criteria: Past or current exudative AMD or any geographic atrophy (on fundus autofluorescence) in study eye; past or current other retinal or choroidal vasculopathy in study eye (e.g. pigment epithelial detachment, polypoidal choroidal vasculopathy, central serous retinopathy, retinal vein occlusion, sickle cell retinopathy); uncontrolled hypertension (>150 systolic or >95 diastolic); diabetes mellitus; glaucoma
Information: pralston@macuclear.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, plaque brachytherapy, or external-beam radiation therapy
Information: research@midatlanticretina.com

► 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 agen in patients with Neovascular AMD
Design: Interventional, Nonrandomized, Safety, Parallel Assignment, Open Label
Number of Patients: 34
Inclusion Criteria: CNV secondary to AMD, as confirmed by the patient’s medical history and a documented diagnosis of CNV; distance BCVA of 20/100 or worse
Exclusion Criteria: CNV in the study eye due to any reason other than AMD; history of conditions in the study eye during Screening which might alter visual acuity or interfere with study testing
Information: medinfo@genzyme.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; diagnosis of CNV secondary to AMD in at least one eye
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: itaraporewala@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 eye that involves the center of the fovea, if the size of the hemorrhage is either > 50% of the total area of the lesion or > 1 disc area (2.54 mm2) in size
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; prior systemic anti-VEGF therapy is only allowed up to 3 months prior to first dose
Information: singhr@ccf.org

► Study: Retinal and RPE Autoimmunity in AMD - Correlation With Lucentis Therapy (Antibody)
Sponsor: Lawrence S. Morse, MD/Genentech
Purpose: To determine if “wet” AMD patients differ from patients with “dry” AMD or normal eyes in the production of anti-RPE or anti-retinal antibody formation
Design: Interventional, Nonrandomized, Parallel Assignment, Open Label, Treatment Number of Patients: 131
Inclusion Criteria: Patients with active neovascular AMD naïve to treatment or treated with 4 or more monthly injections of anti-VEGF treatment without an adequate response
Exclusion Criteria: Concurrent eye disease in the study eye that could compromise visual acuity; previous AMD therapy; patients being treated for autoimmune or other disease with immunomodulatory drugs
Information: lsmorse@ucdavis.edu

► 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 in at least one eye; history of treatment with at least 3 doses of anti-VEGF therapy
Exclusion Criteria: History of recurrent non-response to anti-VEGF therapy in the study eye; in the study eye, retinal disease other than AMD; CNV not due to AMD
Information: (862) 778-8300

► Study: TURF: Study for Recalcitrant AMD
Sponsor: Regeneron/Greater Houston Retina Research
Purpose: To study 50 patients with recalcitrant exudative AMD with a history of retinal or subretinal fluid after multiple intravitreal injections with ranibizumab 0.5 mg and subsequently treated with ranibizumab 2.0 mg, who are incomplete responders to 2.0 mg
Design: Interventional, Efficacy, Single Group, Open Label, Treatment
Number of Patients: 50
Inclusion Criteria: CNV secondary to AMD; history of treatment with 0.5 mg ranibizumab followed by 2.0 mg ranibizumab for AMD; BCVA between 20/20 to 20/400
Exclusion Criteria: Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline; prior PDT within the past 3 months or more than 4 prior PDT treatments
Information: dmbmd@houstonretina.com

► Study: Study of Bimonthly VEGF Trap-Eye Compared to As-needed Administration or Other Therapy for Exudative Age-Related Macular Degeneration
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, including PDT, bevacizumab, triamcinolone, or dexamethasone
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 anatomic and visual outcomes compared to patients not receiving oral Zeaxanthin
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: Evidence of diabetic retinopathy or other retinal disease other than age-related macular degeneration; any severe active ocular disease or condition that in the opinion of the investigator is severe enough to prevent a 3-line improvement in visual acuity or to compromise the study results
Information: rjolk@retina-stl.com

► Study: Evaluation of AGN-150998 in Exudative Age-Related Macular Degeneration
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: COMPASS: Clinical Assessment Of AMD Patients After Early Diagnosis and Treatment With Ranibizumab
Sponsor: UC, San Diego/Genentech
Purpose: To determine if patients treated early after diagnosis of wet AMD can return/maintain to their baseline predisease BCVA
Design: Intervention, Safety/Efficacy, Single-group 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
Information: CJL015@ucsd.edu

► Study: ESBA1008 Safety, Tolerability and Effects in Wet AMD Patients
Sponsor: Alcon Research
Purpose: To evaluate the safety, tolerability and effects of an investigational drug ESBA1008 for the treatment of exudative AMD
Design: Interventional, Randomized, Parallel Assignment, Double-blind, Treatment
Number of Patients: 90
Inclusion Criteria: Primary subfoveal 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
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
Information: (888) 451-3937

► 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 in the study eye at the baseline visit; participant has other active ocular or macular diseases or other known ocular disorders
Information: prpl@mail.cc.nih.gov

► Study: CFH&AMD: Complement Factor H Haplotypes and Smoking in AMD
Sponsor: Department of Veterans Affairs
Purpose: To tese 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
Inclusion Criteria: Clear diagnosis of AMD
Exclusion Criteria: Ocular diseases that might simulate AMD or preclude its diagnosis
Information: rohrer@musc.edu

► Study: Tools to Optimize Patient Presentation After Onset of Exudative AMD
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
Information: gdagnelie@jhmi.edu

► 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: Prospective Randomized Trial of Proton Beam CombinedWith 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: 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 AMD
Design: Interventional, Safety/Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: 20
Inclusion Criteria: Active CNV associated with AMD; no previous treatment with anti-VEGF therapy OR prior anti-VEGF therapy with evidence of response to treatment and the need for additional treatment
Exclusion Criteria: Previous treatment with PDT, external beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy in the study eye; CNV due to causes other than AMD
Information: brittanybrown@trialrunners.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 um 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); history of neovascular age-related macular degeneration or choroidal neovascular membrane; history of juxtafoveal telangiectasia
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, Single-group 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 microns 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; previous injection of anti-VEGF or steroid in the study eye within 90 days; vitrectomy, cataract surgery, or YAG capsulotomy within 90 days
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 Board-certified 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, no history of intraocular surgery, ocular laser treatments for any retinal disease, or ocular injections for diabetic macular edema or proliferative disease; no media opacity precluding good retinal photography
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; or previous intraocular injections for the treatment of diabetic retinopathy; a media opacity in either eye that is severe enough to preclude good retinal photography
Information: (713) 559-5200

► Study: Protocol T: Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for DME
Sponsor: DRCR.net/NEI/Genentech/Regeneron
Purpose: To compare the efficacy and safety of (1) intravitreal aflibercept, (2) intravitreal bevacizumab, and (3) intravitreal ranibizumab when given to treat central-involved DME in eyes with visual acuity of 20/32 to 20/320
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Singleblind, Treatment
Inclusion Criteria: BCVA between 20/32 and 20/320 within eight days of randomization; definite retinal thickening due to DME involving the center of the macula; DME present on OCT, within eight days of randomization
Exclusion Criteria: Macular edema is considered to be due to a cause other than DME; macular edema considered to be related to ocular surgery; vitreoretinal interface abnormalities are the primary cause of macular edema
Information: (863) 682-7474

► 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, Double-blind, 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; eye has retinal thickness in the central subfield on baseline OCT measurement greater than or equal to 330 microns, as measured by Cirrus OCT
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 (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non-retinal condition); eye has an ocular condition present (other than DR) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.)
Information: wileyhe@mail.nih.gov

► Study: Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With DME
Sponsor: Allergan
Purpose: To compare the safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with DME
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Single-blind, Treatment
Number of Patients: 300
Inclusion Criteria: Diagnosis of macular edema; visual acuity between 20/200 to 20/40
Exclusion Criteria: Eye surgery to the study eye within 3 months; use of Ozurdex within 9 months; any active ocular inflammation and infection; diagnosis of glaucoma; use of anti-VEGF treatment within 3 months in the eye or systemic use within 6 months
Information: clinicaltrials@allergan.com

► Study: Safety and Pilot Efficacy of AKB-9778 in Subjects With DME
Sponsor: Aerpio Therapeutics
Purpose: To evaluate the safety, pharmacokinetics, pharmacodynamics, and pilot efficacy of multiple ascending dose levels of AKB-9778 given as subcutaneous injections daily for 28 days in patients with DME
Design: Interventional, Safety, Single Group Assignment, Open Label, Treatment
Number of Patients: 24
Inclusion Criteria: Decrease in vision determined to be primarily the result of DME in the study eye; definite retinal thickening due to diffuse DME involving the center of the macula in the study eye; mean central subfield thickness of at least 325 microns by OCT in the study eye.
Exclusion Criteria: Panretinal scatter photocoagulation (PRP) or focal laser within 12 weeks prior to Screening; prior pars plana vitrectomy within 12 weeks prior to Screening; any ocular surgery within 12 weeks prior to Screening; YAG capsulotomy within 7 days prior to Screening
Information: kpeters@aerpio.com

► Study: iDEAL: Randomized, Multi-center, Phase II Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of DME
Sponsor: Quan Dong Nguyen/Juvenile Diabetes Research Foundation/iCo Therapeutics, Inc.
Purpose: To assess the safety of repeated iCo-007 intravitreal injections in treatment of subjects with diabetic macular edema as monotherapy and in combination with ranibizumab or laser photocoagulation
Design: Interventional, Randomized, Safety/Efficacy, Factorial Assignment, Open Label
Number of Patients: 208
Inclusion Criteria: Have diabetes mellitus type I or II (insulin or non-insulin dependent) with HbA1c ≥ 5.5% and HbA1c ·13%; have nonproliferative diabetic retinopathy, or inactive proliferative diabetic retinopathy, or proliferative diabetic retinopathy with a reasonable expectation that panretinal photocoagulation will not be required during the study follow-up period; have diabetic macular edema with central subfield thickness of ≥ 250 microns (confirmed by Stratus TD OCT) Have best corrected visual acuity (ETDRS) that is Snellen equivalent of 20/32 and ≥ 20/320, inclusive
Exclusion Criteria: Have macular or perimacular edema secondary to an etiology other than diabetes; have concurrent retinal diseases other than diabetic retinopathy; have additional ocular diseases compromising visual acuity and/or interfering with study assessments
Information: qnguyen4@jhmi.edu

► Study: Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema
Sponsor: Retina Macula Institute/Allergan
Purpose: To test the efficacy of an 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
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 4 months prior to screening.
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
Information: (727) 323-0077

► Study: Near-infrared Light (NIR) 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 therapy on anatomic and functional abnormalities of DME as assessed by VA, OCT multifocal electroretinography and fundus bimicroscopy
Design: Interventional, Nonrandomized, Safety/Efficacy, Single-group Assignment, Open Label
Number of Patients: 20
Inclusion Criteria: Fellow eye meets criteria; able to successfully tolerate a 3-month deferral of laser photocoagulation
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 or plan to do so
Information: hwhelan@mcw.edu

► Study: Evaluation of Single Nucleotide Polymorphisms (SNPs) in Patients With and Without DME
Sponsor: NEI/NIH Clinical Center
Purpose: To investigate genetic factors that may influence the development of DME
Design: Observational, Prospective
Number of Patients: 400
Inclusion Criteria: Participant is diagnosed with active 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; or participant has evidence of focal laser scars indicative of prior DME Investigators will verify the laser therapy was performed for DME via medical records, FA or photographs
Exclusion Criteria: Another retinal disease that may confound the evaluation of the DME; participant has opacities of the ocular media, or other problems sufficient to preclude adequate dilated examination
Information: (800) 411-1222

► Study: Dextromethorphan for DME
Sponsor:NEI/NIH Clinical Center
Purpose: To see if dextromethorphan can help treat diabetic macular edema
Design: Interventional, Safety/Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: 8
Inclusion Criteria: VA between 20/32 and 20/200; definite retinal thickening due to DME involving the center of the macula
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
Information: (800) 411-1222

► Study: ORVO: Ozurdex for RVO
Sponsor: Johns Hopkins University/Allergan
Purpose: To measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema after an injection of Ozurdex
Design: Interventional, Nonrandomized, Single-group Assignment, Open Label, Treatment
Number of Patients: 40
Inclusion Criteria: Diagnosis of macular edema due to central or BRVO; intraretinal or subretinal fluid in the macula determined by Spectralis OCT; BCVA score in the study eye of 20/30 to 20/400
Exclusion Criteria: Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye; intraocular surgery in the study eye within 3 months of study entry
Information: ghafiz1@jhmi.edu

► Study: Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab for Central RVO
Sponsor: Texas Retina Associates
Purpose: To determine if the addition of Ozurdex to bevacizumab eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic CRVO Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Single-blind
Number of Patients: 68
Exclusion Criteria: Any systemic disease or clinical evidence of any condition which would make the subject , in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; use of systemic steroids within 1 month prior to Baseline Visit (Visit 1) or anticipated use at any time during the study (inhaled and intranasal steroids are allowed); sitting systolic blood pressure equal to or greater than 160 mmHg or diastolic blood pressure equal to or greater than 100 mmHg at the Baseline VisitInformation: kcsaky@texasretina.com

► Study: REVOLUTION: REtinal Vein OccLUsion Treatment With Scatter Laser Guided by UWFA in combiNAtion With Ranibizumab Study
Sponsor: Retina Association of Florida, PA
Purpose: To compare the gold standard of monthly ranibizumab injections with ranibizumab + peripheral scatter laser to the areas of nonperfusion on angiography
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Single-blind, Treatment
Number of Patients: 20
Inclusion Criteria: Fovea-involved macular edema of less than 12 months peripheral nonperfusion defined as at least 5 disc areas of contiguous nonperfusion
Exclusion Criteria: Therapy with intravitreal triamcinolone, pegaptanib, ranibizumab, or bevacizumab within the previous 3 months; previous scatter laser photocoagulation
Information: ivansuner@gmail.com

► Study: RELATE: Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions
Sponsor: Peter A. Campochiaro, MD/Genentech
Purpose: To evaluate the safety and tolerability of intraocular injections of 0.5 or 2.0 mg of ranibizumab in patients with macular edema due to RVO
Design: Interventional, Randomized, Safety, Parallel Assignment, Open Label, Treatment
Number of Patients: 80
Inclusion Criteria: Diagnosis of macular edema due to central or branch RVO; foveal thickness of equal to or greater than 250 mm, as assessed by OCT
Exclusion Criteria: Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye; intraocular surgery in the study eye within 3 months of study entry Information: ghafiz@jhmi.edu

► Study: FAVOR: Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina
Sponsor: Alimera
Purpose: To assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO
Design: Interventional, Randomized, Parallel Assignment, Double-blind, Treatment
Number of Patients: 20
Inclusion Criteria: Diagnosis of macular edema due to BRVO OR CRVO
Exclusion Criteria: Macular edema secondary to any condition other than RVO; presence of foveal atrophy, dense pigmentary changes in the study eye
Information: Kathleen.billman@alimerasciences.com

► Study: OzurdexWith Rescue Lucentis for Treating Macular Edema Secondary to RVO
Sponsor: Wills Eye Institute
Purpose: To compare dexamethasone implant with rescue intravitreal ranibizumab to monthly intravitreal ranibizumab for the treatment of macular edema secondary to branch or central RVO
Design: Randomized, Efficacy, Parallel Assignment, Open Label, Treatment
Number of Patients: 30
Inclusion Criteria: Must be diagnosed within two weeks of onset of symptoms; BCVA between 20/40 and 20/320
Exclusion Criteria: Patients with any history of prior intravitreal dexamethasone or anti-VEGF or grid laser

► Study: Comparison of Initial Ozurdex to Avastin 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 or Avastin
Design: Interventional, Randomized, Efficacy, Parallel Assignment, Single-blind, Treatment
Number of Patients: 30
Inclusion Criteria: Presence of central RVO; VA between 3 and 72 letters and Snellen equivalent of 20/40 to 20/800
Exclusion Criteria: History of glaucoma in the study eye with intraocular pressure > 21mmHg on >1 topical medication
Information: (631) 234-5666

► Study: Study to Assess the Clinical Efficacy and Safety of VEGF Trap-Eye (Intravitreal Aflibercept Injection), Also Commercially Known as EYLEA in Patients With BRVO
Sponsor: Regeneron
Purpose: To assess the efficacy and safety of VEGF Trap-Eye compared to laser in patients with macular edema secondary to BRVO
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind
Number of Patients: 180
Inclusion Criteria: Foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months
Exclusion Criteria: Current bilateral manifestation of BRVO; uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery
Information: clinicaltrials@regeneron.com

► Study: Intra-arterial Thrombolysis for Severe Recent Central RVO
Sponsor: Weill Medical College of Cornell
Purpose: To investigate whether this intervention may reopen the central retinal vein and improve retinal blood flow
Design: Interventional, Safety/Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: 5
Inclusion Criteria: Severe CRVO diagnosed on presence of relative afferent papillary defect or visual acuity of 20/200 or worse; symptom onset within 2 weeks
Exclusion Criteria: Futile intervention: no light perception, absence of perfusion on fluorescein angiography; contra-indication to thrombolysis: active or recent (1 month) internal bleeding, cerebrovascular accident, major organ surgery
Information: kas2004@med.cornell.edu

► Study: WAVE: Targeted Laser With Lucentis 0.5mg Verses Lucentis 0.5mg Monotherapy for Ischemic Central Vein Occlusion
Sponsor: Genentech/Charles C. Wykoff, MD
Purpose: To see if Lucentis 0.5mg combined with Targeted Pan Retinal photocoagulation will decrease the total number of intravitreal injections in a year for ischemic central RVO, compared to standard of care
Design: Interventional, Randomized, Safety/Efficacy, Single Group Assignment, Open Label, Treatment
Number of Patients: 30
Inclusion Criteria: Subjects with Ischemic CRVO with at least 2 consecutive monthly intravitreal injections of anti-VEGF medications with presence of persistent edema in the past 4 months
Exclusion Criteria: IOP over 30 mm Hg Any previous retinal laser photocoagulation to the study eye; previous intravitreal injection in the study eye of any corticosteroid treatment
Information: dmbmd@houstonretina.com

► Study: Minocycline to Treat BRVO
Sponsor: National Eye Institute
Purpose: To test the safety and effectiveness of minocycline as a treatment for branch RVO
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind
Number of Patients: 20
Inclusion Criteria: The study eye shows evidence of definite retinal thickening due to a BRVO based on clinical examination
Exclusion Criteria: Participant is in another investigational study and actively receiving investigational product for BRVO
Information: prpl@mail.cc.nih.gov

► Study: CRAVE: Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion
Sponsor: Barnes Retina Institute
Purpose: To measure the change in central retinal thickness after either treatment
Design: Interventional, Randomized, Efficacy Study, Parallel Assignment, Single-blind, Treatment
Number of Patients: 150
Inclusion Criteria: Visual acuity of 20/40 -20/320 in the study eye (regardless of relative APD); central foveal thickness (CFT) of > 250 microns as assessed by OCT (see below); diagnosis of RVO in the past 9 months
Exclusion Criteria: History of previous intraocular surgery in the study eye, including pars plana vitrectomy (but not including uncomplicated cataract surgery)
Information: (314) 367-1181

► Study: Optiquel as Corticosteroid-sparing Therapy for Chronic Noninfectious Uveitis
Sponsor: National Eye Institute
Purpose: To evaluate the safety and effectiveness of Optiquel as a treatment for uveitis
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind
Number of Patients: 60
Inclusion Criteria: Participant has been diagnosed with non-infectious unilateral or bilateral uveitis for at least three months.; participants who were diagnosed more than a year ago must have had a recurrence in ocular inflammation within the past year
Exclusion Criteria: Participant has a non-iatrogenic immunodeficiency state; participant had intra-ocular surgery or intraocular injection within three months prior to randomization; participant is expected to have an elective ocular surgery or intraocular injection during the study period
Information: dobiyor@mail.nih.gov

► Study: The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease
Sponsor: National Eye Institute
Purpose: To study the vitreous that will be removed from patients’ eyes during an operation to insert a steroid implant
Design: Observational
Number of Patients: 300
Information: patti.sherr y@nih.gov

► Study: Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious Uveitis
Sponsor: XOMA (US), LLC/Institut de Recherches Internationales Servier
Purpose: To evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or panuveitis
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind
Number of Patients: 300
Inclusion Criteria: Diagnosis of noninfectious intermediate, posterior, or pan- uveitis in at least one eye; active uveitic disease in at least one eye; currently on one of the following stable treatment regimens for uveitis: oral corticosteroids; systemic immunosuppression
Exclusion Criteria: Infectious uveitis and masquerade syndromes; isolated anterior uveitis; contraindication to mydriatics; history of allergic or anaphylactic reactions to monoclonal antibodies
Information: nathr@xoma.com

► Study: Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis
Sponsor: Abbott
Purpose: To compare the safety and efficacy of Adalimumab vs. Placebo in subjects with inactive uveitis
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind
Number of Patients: 250
Inclusion Criteria: Subject is diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis; subject that for >/= 28 days prior to the Baseline visit has inactive disease and is taking >/= 10 mg of oral prednisone to maintain this inactive state
Exclusion Criteria: Isolated anterior uveitis; confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus, Lyme disease, toxoplasmosis, Human T-Lymphotropic Virus Type 1 infection, Whipple’s disease, herpes zoster virus and herpes simplex virus
Information: andrea.byars@abbott.com

► Study: Treatment of Non-infectious Intermediate and Posterior Uveitis Associated Macular Edema With Intravitreal Methotrexate
Sponsor: National Eye Institute
Purpose: To evaluate the safety and effectiveness of methotrexate as a treatment for macular edema associated with uveitis
Design: Interventional, Safety/Efficacy, Single-group Assignment, Open Label, Treatment
Number of Patients: 7
Inclusion Criteria: Chronic macular edema secondary to noninfectious panuveritis posterior or intermediate uveitis in at least one eye that has not been responsive to conventional immunosuppression in 3 months
Exclusion Criteria: Participant has evidence of infectious panuveritis posterior or intermediate uveitis in either eye; participant is expected to need ocular surgery in the study eye during the course of the trial
Information: patti.sherry@nih.gov

► Study: SAKURA: Study Assessing Double-masked Uveitis Treatment
Sponsor: Santen, Inc.
Purpose: To evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution
Design: Interventional, Randomized, Safety/Efficacy, Parallel Assignment, Double-blind Number of Patients: 500
Inclusion Criteria: Confirmed diagnosis of active uveitis
Exclusion Criteria: Uveitis of infectious etiology; suspec ted/confirmed central nervous system or ocular lymphoma; primary diagnosis of anterior uveitis; uncontrolled glaucoma; use of topical oculary medication; implanted device
Information: clinicaltrials@santeninc.com