A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
Public ClinicalTrials.gov record NCT04603937. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.
Study identification
- NCT ID
- NCT04603937
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 459 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2020 (Actual)
- Primary completion
- Apr 27, 2023 (Actual)
- Completion
- Aug 31, 2023 (Actual)
- Last update posted
- Aug 22, 2024
2020 – 2023
United States locations
- U.S. sites
- 40
- U.S. states
- 19
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Retinal Research Institute, LLC | Phoenix | Arizona | 85014 | — |
| Retina Vitreous Associates | Beverly Hills | California | 90211 | — |
| Retina Consultants of Orange County | Fullerton | California | 92835 | — |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | — |
| Retina Consultants of San Diego | Poway | California | 92064 | — |
| Retinal Consultants Medical Group Inc | Sacramento | California | 95825 | — |
| Retina Group of New England | Waterford | Connecticut | 06385 | — |
| Florida Eye Microsurgical Institute | Boynton Beach | Florida | 33426 | — |
| Rand Eye Institute | Deerfield Beach | Florida | 33064 | — |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | — |
| Fort Lauderdale Eye Institute | Plantation | Florida | 33324 | — |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33703 | — |
| Southern Vitreoretinal Associates | Tallahassee | Florida | 32308 | — |
| Southeast Retina Center | Augusta | Georgia | 30909 | — |
| Georgia Retina, P.C. | Marietta | Georgia | 30060 | — |
| Retina Consultants of Hawaii, Inc | ‘Aiea | Hawaii | 96701 | — |
| Retina Specialists of Idaho | Boise | Idaho | 83713 | — |
| Talley Eye | Evansville | Indiana | 47710 | — |
| Maine Eye Center | Portland | Maine | 04101 | — |
| Associated Retinal Consultants PC | Royal Oak | Michigan | 48073 | — |
| Vitreoretinal Surgery PA | Minneapolis | Minnesota | 55435 | — |
| Retina Consultants of NV | Henderson | Nevada | 89052 | — |
| Sierra Eye Associates | Reno | Nevada | 89502 | — |
| Vitreo Retinal Consultants | Hauppauge | New York | 11788 | — |
| Retina-Vitreous Surgeons of Central NY | Liverpool | New York | 13088 | — |
| Ophthalmic Consultants of Long Island | Oceanside | New York | 11572 | — |
| Retina Associates of Western NY | Rochester | New York | 14620 | — |
| Asheville Eye Associates | Asheville | North Carolina | 28803 | — |
| Cleveland Clinic Foundation, Cole Eye Institute | Cleveland | Ohio | 44195 | — |
| Retina Consultants, LLC | Salem | Oregon | 97302 | — |
| Southeastern Retina Associates PC | Knoxville | Tennessee | 37922 | — |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | — |
| Austin Research Center for Retina | Austin | Texas | 78705 | — |
| Texas Retina Associates | Fort Worth | Texas | 76108 | — |
| Retina Consultants of Houston-(Katy) | Katy | Texas | 77494 | — |
| Texas Retina Associates | Plano | Texas | 75075 | — |
| Austin Retina Associates (Round Rock) | Round Rock | Texas | 78681 | — |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | — |
| Retina Consultants of Houston - (Woodlands) | The Woodlands | Texas | 77384 | — |
| Retina Institute of Virginia | Richmond | Virginia | 23235 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 32 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04603937, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 22, 2024 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04603937 live on ClinicalTrials.gov.