A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
Public ClinicalTrials.gov record NCT04611152. 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
- NCT04611152
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 460 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
- May 11, 2023 (Actual)
- Completion
- Aug 31, 2023 (Actual)
- Last update posted
- Aug 22, 2024
2020 – 2023
United States locations
- U.S. sites
- 48
- U.S. states
- 21
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSD Jacobs Retina Center | La Jolla | California | 92037 | — |
| Retina Consultants of Southern California | Redlands | California | 92374 | — |
| California Retina Consultants | Santa Maria | California | 93454 | — |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| Colorado Retina Associates PC | Lakewood | Colorado | 80228 | — |
| Conneticut Eye Consultants | Danbury | Connecticut | 06810 | — |
| Retina Group of Florida | Boca Raton | Florida | 33431 | — |
| Blue Ocean Clinical Research | Clearwater | Florida | 33761 | — |
| Vitreo Retinal Associates | Gainesville | Florida | 32607 | — |
| Florida Retina Consultants | Lakeland | Florida | 33805 | — |
| Florida Eye Associates | Melbourne | Florida | 32901 | — |
| Florida Retina Institute | Orlando | Florida | 32806 | — |
| Retina Specialty Institute | Pensacola | Florida | 32503 | — |
| Retina Associates of Florida | Tampa | Florida | 33609 | — |
| Retina Vitreous Associates of Florida | Tampa | Florida | 33617 | — |
| Center for Retina & Macular Disease | Winter Haven | Florida | 33880 | — |
| Springfield Clinic LLP | Springfield | Illinois | 62703 | — |
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | — |
| Retina Associates PA | Lenexa | Kansas | 66215 | — |
| Vitreo Retinal Consultants and Surgeons | Wichita | Kansas | 67214 | — |
| Retina Associates of Kentucky | Lexington | Kentucky | 40509 | — |
| Cumberland Valley Retina Consultants PC | Hagerstown | Maryland | 21740 | — |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | — |
| Foundation for Vision Research | Grand Rapids | Michigan | 49525 | — |
| The Retina Center of New Jersey | Bloomfield | New Jersey | 07017 | — |
| NJ Retina | Teaneck | New Jersey | 07605 | — |
| Charlotte Eye Ear Nose & Throat Associates, P.A. | Charlotte | North Carolina | 28210 | — |
| Retina Northwest | Portland | Oregon | 97210 | — |
| Cascade Medical Research Institute | Springfield | Oregon | 97477 | — |
| MidAtlantic Retina | Philadelphia | Pennsylvania | 19107 | — |
| Retina Research of Beaufort | Beaufort | South Carolina | 29902 | — |
| Charleston Neuroscience Institute - West Ashley | Charleston | South Carolina | 29414 | — |
| Pametto Retina Center | Florence | South Carolina | 29501 | — |
| Charleston Neuroscience Institute | Ladson | South Carolina | 29456 | — |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | — |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | — |
| Charles Retina Institute | Germantown | Tennessee | 38138 | — |
| Tennessee Retina PC | Nashville | Tennessee | 37203 | — |
| Southwest Retina Specialists | Amarillo | Texas | 79106 | — |
| Texas Retina Associates | Arlington | Texas | 76012 | — |
| Austin Retina Associates | Austin | Texas | 78705 | — |
| Star Retina | Burleson | Texas | 76028 | — |
| Retina Consultants of Texas | Houston | Texas | 77030 | — |
| Retina Consultants of San Antonio | San Antonio | Texas | 78240 | — |
| Strategic Clinical Research Group, LLC | Willow Park | Texas | 76087 | — |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | — |
| Retina Center Northwest | Silverdale | Washington | 98383 | — |
| Spokane Eye | Spokane | Washington | 99204 | — |
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 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04611152, 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 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04611152 live on ClinicalTrials.gov.