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.

• Status: Active, not recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kodiak Sciences Inc
• Treatments: Aflibercept; Antibodies

Criteria

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.