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Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Aug 31, 2026 → Oct 31, 2026
See other at-risk trials from Kyowa Kirin Co., Ltd.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 31, 2026 to Oct 31, 2026 Show 4 more changesShow less
    • Final enrollment: 185 participants (planned 150)
    • Study completion pushed from Sep 30, 2026 to Nov 30, 2026
    • Eligibility criteria expanded, about 25 words
    • Site details revised at 3 of 87 sites
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 87 of 87 sites
    v21
  3. Site details revised at 4 of 87 sitesv20
  4. Site details revised at 1 of 87 sitesv19
  5. Primary completion date: Nov 2025 to Aug 31, 2026
    • Study completion date: Dec 2025 to Sep 30, 2026
    • Eligibility criteria revised
    • Site details revised at 1 of 87 sites
    v18
Show 16 earlier versionsHide 16 earlier versions
  1. Site contacts updated at 1 of 87 sitesv17
  2. Eligibility criteria expanded, about 26 words
    • Site details revised at 5 of 87 sites
    v16
  3. Study sites: 86 to 87v15
  4. Lead sponsor: Kyowa Kirin, Inc. to Kyowa Kirin Co., Ltd.
    • Site details revised at 2 of 86 sites
    v14
  5. Site details revised at 3 of 86 sitesv13
  6. Site details revised at 4 of 86 sitesv12
  7. Eligibility criteria expanded, about 63 words
    • Site details revised at 6 of 86 sites
    v11
  8. Site details revised at 7 of 86 sitesv10
  9. Site details revised at 7 of 86 sitesv9
  10. Site details revised at 10 of 86 sitesv8
  11. Study sites: 85 to 86v7
  12. Site details revised at 8 of 85 sitesv6
  13. Re-verified, no change to tracked fieldsv5
  14. Study sites: 81 to 85v4
  15. Study sites: 80 to 81
    • Study title shortened, about 2 words
    v3
  16. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 30 to 80
    • Start date changed from estimate of Nov 2023 to Jan 9, 2024
    • Study title shortened, about 1 word
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
Trial Details
NCT Number NCT06116916
Lead Sponsor Kyowa Kirin Co., Ltd.
Conditions
(from sponsor)		 Diabetic Macular Edema (DME)
Enrollment 185 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov