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Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR

Study acronym: AP
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 32 to 34
    • Eligibility criteria expanded, about 16 words
  2. Study sites: 30 to 32v10
  3. Study sites: 28 to 30v9
  4. Study sites: 27 to 28v8
  5. Trial sites expanded: 20 → 27 locationsv7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 14 to 20v6
  2. Study sites: 5 to 14v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Aug 2029 to Aug 2031
    • Start date changed from estimate of Aug 2025 to Aug 4, 2025
    • Site details revised at 5 of 5 sites
    v4
  4. Study sites: 0 to 5v3
  5. Start date: Mar 2025 to Aug 2025
    • Primary completion date: Mar 2029 to Aug 2029
    • Study completion date: Mar 2031 to Aug 2031
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This randomized trial will compare treatment strategies for proliferative diabetic retinopathy (PDR). Participants will receive either combination a of faricimab + PRP or vitrectomy + endolaser. The participants will be followed for 3 years. The study will evaluate long-term visual acuity as well as differences in number of injections, procedures, and complications during follow-up (after completion of randomization treatment), and cost.
Trial Details
NCT Number NCT06790784
Lead Sponsor Jaeb Center for Health Research
Collaborators: National Eye Institute (NEI), Genentech, Inc.
Conditions
(from sponsor)		 Proliferative Diabetic Retinopathy (PDR)
Enrollment 426 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov