Status:
TERMINATED
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.
Lead Sponsor:
Kodiak Sciences Inc
Conditions:
Wet Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
PHASE3
Brief 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 ev...
Detailed Description
This study is divided into a 3-week screening period, a 92-week treatment period, and a final 4-week follow-up period. At baseline patients will be randomized 1:1 into two treatment arms: KSI-301 5 mg...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2022
Estimated Enrollment :
559 Patients enrolled
Trial Details
Trial ID
NCT04049266
Start Date
October 8 2019
End Date
April 26 2022
Last Update
July 18 2024
Active Locations (75)
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1
Retinal Research Institute, LLC
Phoenix, Arizona, United States, 85014
2
Northwest Arkansas Retina Associates
Springdale, Arkansas, United States, 72762
3
California Retina Consultants
Bakersfield, California, United States, 93309
4
Retina Vitreous Associates
Beverly Hills, California, United States, 90211