Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
NCT06116916 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06116916
The ClinicalTrials.gov registry entry for NCT06116916 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kyowa Kirin Co., which has 8 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 Diabetic Macular Edema (DME) appearing as the primary indexed condition, and to 2 interventions — of which Aflibercept Injection 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: NCT06116916 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, 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 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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06116916?
The interventions under investigation include: Aflibercept Injection (DRUG), KHK4951 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06116916?
This trial is sponsored by Kyowa Kirin Co., which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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