Overview

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.