CNV secondary to other causes in the Study Eye.Active or suspected ocular or periocular infection or inflammation.BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular).Other protocol-specified inclusion criteria may apply.Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wAMD.BCVA ETDRS score between 83 and 25 letters, inclusive, in the Study Eye.Treatment-naïve choroidal neovascularization (CNV) secondary to AMD.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 Neovascular (Wet) Age-related Macular Degeneration (wAMD) The masked Investigator will be responsible for the examinations and safety assessments. To preserve masking, two investigators are required for this study. 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.
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