A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Pa… (NCT04592419) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)
United States568 participantsStarted 2020-09-25
Plain-language summary
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed informed consent prior to participation in the study.
✓. Treatment-naïve macular edema of 6 months duration or less due to CRVO or BRVO. Participants with hemiretinal vein occlusion will be included as CRVO.
✓. BCVA ETDRS letter score between 80 and 25 (20/25 to 20/320 Snellen equivalent), inclusive in the Study Eye.
✓. CST of ≥ 320 microns on SD-OCT (Heidelberg Spectralis or equivalent on other OCT instruments) as determined by the Reading Center
✓. Decrease in vision determined by the Investigator to be primarily the result of ME secondary to RVO.
✓. Other protocol-specified inclusion criteria may apply.
Exclusion criteria
✕. Macular edema in the Study Eye for reasons other than RVO
✕. Active iris or angle neovascularization, neovascular glaucoma, neovascularization of the optic disc, retinal neovascularization or vitreous hemorrhage in the Study Eye.
✕. Uncontrolled glaucoma in the Study Eye.
✕. Active retinal disease other than the condition under investigation in the Study Eye.
✕. Any history or evidence of a concurrent ocular condition present, that in the opinion of the Investigator could require either medical or surgical intervention alter visual acuity during the study
What they're measuring
1
Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in BRVO Participants.
Timeframe: Day 1 to Week 24
2
Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in All RVO Patients.
. Active or suspected ocular or periocular infection or inflammation
✕. Any prior use of an approved or investigational treatment for macular edema secondary to RVO in the Study Eye (e.g. anti-VEGF, intraocular or periocular steroids, macular laser photocoagulation).
✕. Women who are pregnant or lactating or intending to become pregnant during the study.