A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugat… (NCT04049266) | Clinical Trial Compass
TerminatedPhase 2/3
A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.
Stopped: Primary Endpoint Not Met
United States559 participantsStarted 2019-10-08
Plain-language summary
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* Signed informed consent prior to participation in the study.
* Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
* BCVA ETDRS score between 80 and 25 letters (Snellen equivalent of 20/25 to 20/320), inclusive.
* Other protocol-specified inclusion criteria may apply
Exclusion Criteria:
* CNV secondary to other causes in the Study Eye.
* Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid.
* Any history or evidence of a concurrent intraocular condition in the Study Eye that, in the judgment of the Investigator, could require either medical or surgical intervention during the study to prevent or treat visual loss.
* Active ocular or periocular infection or inflammation.
* Prior administration of any approved or investigational treatment for neovascular AMD in the Study Eye.
* Uncontrolled glaucoma in the Study Eye.
* Women who are pregnant or lactating or intending to become pregnant during the study.
* Stroke or myocardial infarction in the 6-month period prior to Day 1.
* Uncontrolled blood pressure defined as a systolic value \> 180 mmHg or diastolic value ≥100 mmHg while at rest.
* History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
* Other protocol-specified exclusion criteria may apply.
What they're measuring
1
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48 and 52, Full Analysis Set Year 1