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ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)

Study acronym: ReNEW
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 60 words
    • Study description expanded, about 3 words
  2. 2 versions Re-verified since Nov 13, 2025, no change to tracked fieldsv44-v45
  3. Primary completion date: Aug 2026 to Aug 2027v43 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 360 to confirmed 313
    • Study sites: 63 to 53
    • Study completion date: Aug 2027 to Sep 2027
  4. Site details revised at 2 of 63 sitesv42
  5. Eligibility criteria expanded, about 10 words
    • Site details revised at 7 of 63 sites
    v41
Show 39 earlier versionsHide 39 earlier versions
  1. Study sites: 62 to 63v40
  2. Study sites: 61 to 62v39
  3. Study sites: 59 to 61v38
  4. Study sites: 57 to 59v37
  5. Study sites: 56 to 57v36
  6. Study sites: 49 to 56v35
  7. Study sites: 47 to 49v34
  8. Study sites revised (47)v33
  9. Study sites: 46 to 47v32
  10. Study sites: 44 to 46v31
  11. Study sites: 43 to 44v30
  12. Study sites: 42 to 43v29
  13. Study sites: 40 to 42v28
  14. Study sites: 39 to 40v27
  15. Study sites: 37 to 39v26
  16. Study sites: 36 to 37v25
  17. Study sites: 35 to 36v24
  18. Study sites: 33 to 35v23
  19. Study sites: 32 to 33v22
  20. Study sites: 30 to 32v21
  21. Study sites: 29 to 30v20
  22. Study sites: 28 to 29v19
  23. Study sites: 26 to 28v18
  24. Study sites: 23 to 26v17
  25. Study sites: 22 to 23v16
  26. Study sites: 21 to 22v15
  27. Study sites: 20 to 21v14
  28. Study sites: 19 to 20v13
  29. Study sites: 17 to 19v12
  30. Study sites: 16 to 17v11
  31. Study sites: 15 to 16v10
  32. Study sites: 13 to 15v9
  33. Study sites: 12 to 13v8
  34. Study sites: 11 to 12v7
  35. Study sites: 10 to 11v6
  36. Study sites: 3 to 10v5
  37. Study sites: 1 to 3
    • Start date changed from estimate of Jun 2024 to May 30, 2024
    v4
  38. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: May 2024 to Jun 2024
    v3
  39. Study title expanded, about 4 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to evaluate the efficacy, safety and pharmacokinetics of elamipretide in subjects with dry age-related macular degeneration (AMD). The main questions it aims to answer are: what is the rate of change in the macular area of photoreceptor loss in subjects who receive a daily dose of elamipretide compared with those who receive a look-alike substance that contains no active drug, and what is the safety and tolerability of elamipretide daily subcutaneous injections. Participants will receive either once daily subcutaneous doses of 40mg elamipretide or placebo and the two treatment groups will be compared.
Trial Details
NCT Number NCT06373731
Lead Sponsor Stealth BioTherapeutics Inc.
Conditions
(from sponsor)		 Age Related Macular Degeneration (ARMD)
Related terms Macular Degeneration
Enrollment 313 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov