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NCT06116916 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
A Phase 2 study of Diabetic Macular Edema (DME), sponsored by Kyowa Kirin Co..
- Active
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT06116916: Active Phase 2 study of Diabetic Macular Edema (DME), sponsored by Kyowa Kirin Co..
NCT06116916 is a Phase 2 study of Diabetic Macular Edema (DME) that is active but no longer recruiting, run by Kyowa Kirin Co.. The registered enrollment target is 150 participants, below the 343-participant average among 8 other Diabetic Macular Edema (DME) trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06116916, a Phase 2 study of Diabetic Macular Edema (DME), is active but no longer recruiting, sponsored by Kyowa Kirin Co..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
Conditions Studied
Interventions
- DRUG Aflibercept Injection
- DRUG KHK4951
Study Locations (20)
Florida
- Blue Ocean Clinical Research West - Clearwater
- Florida Eye Associates - Melbourne
- Eye Associates of Pinellas - Pinellas Park
- Ft. Lauderdale Eye Institute - Plantation
- Retina Vitreous Associates of Florida - Saint Petersburg - St. Petersburg
- Southern Vitreoretinal Associates - Tallahassee
- Center for Retina and Macular Disease - Ophthalmology - Winter Haven
California
- Win Retina - Arcadia
- Retina Vitreous Associates Medical Group - Beverly Hills
- The Retina Partners - Encino
- Salehi Retina Institute, Inc - Huntington Beach
- California Eye Specialists Medical Group Inc - Pasadena
- Retina Consultants of Southern California - Redlands
Arizona
- Barnet Dulaney Perkins Eye Center - Phoenix - Mesa
- Retina Associates Southwest, P.C. - Tucson
Colorado
- Retina Consultants of Southern CO - Colorado Springs
Maryland
- Mid Atlantic Retina Specialists - Hagerstown - Hagerstown
Nevada
- Sierra Eye Associates - Reno
New Jersey
- Envision Ocular, LLC - Bloomfield
New Mexico
- Vision Research Center Eye Associates of New Mexico - Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-01-09 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 2 |
What the registry record for NCT06116916 still lists
NCT06116916 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 343-participant average among 8 other Diabetic Macular Edema (DME) trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Diabetic Macular Edema (DME) appearing as the primary indexed condition, and to 2 interventions - of which Aflibercept Injection is the first listed.
NCT06116916 names 20 study sites across 8 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06116916 about?
NCT06116916 is a clinical study titled "Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema". The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
What is the current status of trial NCT06116916?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2024-01-09. Estimated completion is 2026-09-30.
What conditions does trial NCT06116916 study?
This clinical trial studies the following conditions: Diabetic Macular Edema (DME).
What interventions are being tested in trial NCT06116916?
The interventions under investigation include: Aflibercept Injection (DRUG), KHK4951 (DRUG).
Who is sponsoring clinical trial NCT06116916?
This trial is sponsored by Kyowa Kirin Co., which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06116916 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Macular Edema (DME)
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 NCT06116916's enrollment target sits among peer trials
150 6th of 8 higher than 3 of 8 other Diabetic Macular Edema (DME) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema (DME) 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
-
A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
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A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
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CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
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COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
RECRUITING · Phase 3
-
A Study of Avoralstat In Participants With Diabetic Macular Edema
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