Springfield, Illinois, United States, 62703 Winter Haven, Florida, United States, 33880
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Gainesville, Florida, United States, 32607 Santa Maria, California, United States, 93454ĭanbury, Connecticut, United States, 06810īoca Raton, Florida, United States, 33431 Redlands, California, United States, 92374 Retina Consultants of Southern California Palo Alto, California, United States, 94303 Laguna Hills, California, United States, 92653 La Jolla, California, United States, 92037
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Any prior use of an approved or investigational treatment for DME in the Study Eye (e.g., anti-VEGF, intraocular or periocular steroids, macular laser photocoagulation).Active or suspected ocular or periocular infection or inflammation in either eye at Day 1.Any history or evidence of a concurrent ocular condition present, that in the opinion of the Investigator could require either medical or surgical intervention or affect macular edema or alter visual acuity during the study (e.g., vitreomacular traction, epiretinal membrane).Active retinal disease other than the condition under investigation in the Study Eye.Tractional retinal detachment in the Study Eye.History of Pan-retinal Photocoagulation (PRP) laser in the Study Eye within 3 months of screening.High-risk proliferative diabetic retinopathy characteristics in the Study Eye.Active iris or angle neovascularization or neovascular glaucoma in the Study Eye.Macular edema in the Study Eye considered to be secondary to a cause other than DME.Other protocol-specified inclusion criteria may apply.Type 1 or Type 2 diabetes mellitus and a HbA1c of ≤12%.Decrease in vision determined by the Investigator to be primarily the result of DME.CST of ≥ 320 microns on SD-OCT (Heidelberg Spectralis or equivalent on other OCT instruments) as determined by the Reading Center.BCVA ETDRS letter score between 78 and 25 (-20/25 to 20/320 Snellen equivalent), inclusive, in the Study Eye.Treatment-naïve diabetic macular edema, with vision loss and center involvement (if present) diagnosed within 9 months of screening.Signed informed consent prior to participation in the study.The unmasked Investigator will perform the injections and post-treatment assessments.Ī Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME) The masked Investigator will be responsible for the examinations and safety assessments. To preserve masking, two investigators are required for this study.
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Triple (Participant, Care Provider, Outcomes Assessor)įor masking purposes, sham injections will be administered at every monthly visit if an active treatment is not administered. Participants will be randomized 1:1 into one of two treatment arms: KSI-301 or aflibercept. Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Why Should I Register and Submit Results?.