A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Af… (NCT04964089) | Clinical Trial Compass
CompletedPhase 3
A 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)
United States557 participantsStarted 2021-06-23
Plain-language summary
This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* Signed informed consent prior to participation in the study.
* Treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
* BCVA ETDRS score between 83 and 25 letters, inclusive, in the Study Eye.
* Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wAMD.
* Other protocol-specified inclusion criteria may apply
Exclusion Criteria:
* BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular).
* Active or suspected ocular or periocular infection or inflammation.
* CNV secondary to other causes in the Study Eye.
* Any history or evidence of a concurrent ocular condition present in the Study Eye, 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.
* Uncontrolled glaucoma in the Study Eye.
* Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT or fundus photography.
* Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening.
* Women who are pregnant or lactating or intending to become pregnant during the study.
* Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event…
What they're measuring
1
Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48.