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NCT04964089 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Wet Age-related Macular Degeneration, sponsored by Kodiak Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 557
- Enrollment target
- 20
- Study locations
NCT04964089: Completed Phase 3 study of Wet Age-related Macular Degeneration, sponsored by Kodiak Sciences.
NCT04964089 is a Phase 3 study of Wet Age-related Macular Degeneration that has completed, run by Kodiak Sciences. The registered enrollment target is 557 participants, above the 355-participant average among 8 other Wet Age-related Macular Degeneration trials with a reported enrollment target (57% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04964089, a Phase 3 study of Wet Age-related Macular Degeneration, has completed, sponsored by Kodiak Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 557 participants
- Enrollment target
- 20
- Study locations
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)
Primary Outcome
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
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 |
What the finished NCT04964089 record still lists
NCT04964089 is an interventional study that assigns participants to a tested intervention. The registered 557 participants enrollment target is mid-sized for trials with a published cap, above the 355-participant average among 8 other Wet Age-related Macular Degeneration trials with a reported enrollment target (57% higher).
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.
NCT04964089 names 20 study sites across 6 states, led by California, Florida, Arizona.
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.
What interventions are being tested in trial NCT04964089?
The interventions under investigation include: Sham Procedure (OTHER), Aflibercept (DRUG), KSI-301 (DRUG).
Who is sponsoring clinical trial NCT04964089?
This trial is sponsored by Kodiak Sciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Wet Age-related Macular Degeneration
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04964089's enrollment target sits among peer trials
557 4th of 8 higher than 5 of 8 other Wet Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Wet Age-related Macular Degeneration trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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-
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A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO) Primary Efficacy Will be Determined at Week 56
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Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]
ACTIVE NOT RECRUITING
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