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A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)
NCT04964089 · View on ClinicalTrials.gov ↗
Study Summary
This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)
Conditions Studied
Interventions
- OTHER Sham Procedure
- DRUG Aflibercept
- DRUG KSI-301
Study Locations (20)
California
- California Retina Consultants — Bakersfield
- Eye Medical Center of Fresno — Fresno
- Retina Consultants of Orange County — Fullerton
- UCSD Jacobs Retina Center — La Jolla
- Retina Associates of Orange County — Laguna Hills
- Northern California Retina Vitreous Associates — Mountain View
- Retina Consultants of San Diego — Poway
- Retina Consultants of Southern California — Redlands
- Retinal Consultants Medical Group Inc — Sacramento
- Orange County Retina Medical Group — Santa Ana
Florida
- Florida Eye Microsurgical Institute — Boynton Beach
- Rand Eye Institute — Deerfield Beach
- Retina Health Center — Fort Myers
- National Ophthalmic Research Institute — Fort Myers
- Florida Eye Associates — Melbourne
- Retina Specialty Institute — Pensacola
Arizona
- Retinal Research Institute, LLC — Phoenix
Arkansas
- Northwest Arkansas Retina Associates — Springdale
Colorado
- Colorado Retina Associates PC — Lakewood
Connecticut
- Retina Group of New England — Waterford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 557 participants |
| Start Date | 2021-06-23 |
| Est. Completion | 2023-04-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04964089
The ClinicalTrials.gov registry entry for NCT04964089 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 557 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kodiak Sciences, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Wet Age-related Macular Degeneration appearing as the primary indexed condition, and to 3 interventions — of which Sham Procedure is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04964089 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04964089 about?
NCT04964089 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)". This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)
What is the current status of trial NCT04964089?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 557 participants. The study started on 2021-06-23. Estimated completion is 2023-04-06.
What conditions does trial NCT04964089 study?
This clinical trial studies the following conditions: Wet Age-related Macular Degeneration. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04964089?
The interventions under investigation include: Sham Procedure (OTHER), Aflibercept (DRUG), KSI-301 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04964089?
This trial is sponsored by Kodiak Sciences, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04964089 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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