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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 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.

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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

Diabetic Macular Edema (DME)

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

FieldValue
Enrollment Target 150 participants
Start Date 2024-01-09
Est. Completion 2026-09-30
Phase Phase 2

Sponsor

Kyowa Kirin Co.

25 total trials

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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, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 343-participant average among 8 other Diabetic Macular Edema (DME) trials with a reported enrollment target (56% lower). The listed sponsor is Kyowa Kirin Co., which has 25 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.