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Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy

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

Record History

  1. Study sites: 25 to 27v18
  2. Study sites: 24 to 25v17
  3. Study sites: 23 to 24v16
  4. Study sites: 22 to 23v15
  5. Study sites: 20 to 22v14
Show 12 earlier versionsHide 12 earlier versions
  1. Study sites: 19 to 20v13
  2. Study sites: 18 to 19v12
  3. Study sites: 16 to 18v11
  4. Study sites: 15 to 16v10
  5. Study sites: 14 to 15v9
  6. Primary completion date: Nov 26, 2026 to Dec 26, 2029
    • Study completion date: Nov 26, 2028 to Dec 26, 2029
    v8
  7. Study sites: 13 to 14v7
  8. Study sites: 12 to 13v6
  9. Study sites: 10 to 12v5
  10. Study sites: 6 to 10v4
  11. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 6
    • Primary completion date: Oct 26, 2026 to Nov 26, 2026
    • Study completion date: Oct 26, 2028 to Nov 26, 2028
    • Start date changed from estimate of Oct 26, 2023 to Nov 21, 2023
  12. Start date: Jun 15, 2023 to Oct 26, 2023
    • Primary completion date: Jul 15, 2026 to Oct 26, 2026
    • Study completion date: Jul 2028 to Oct 26, 2028
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 controlled trial will evaluate the effect of intravitreal faricimab or fluocinolone acetonide (FAc) intravitreal implant compared with observation on long-term visual acuity following treatment of choroidal melanoma with iodine-125 plaque brachytherapy.
Trial Details
NCT Number NCT05844982
Lead Sponsor Jaeb Center for Health Research
Collaborators: National Eye Institute (NEI), National Institutes of Health (NIH), Alimera Sciences, Genentech, Inc.
Conditions
(from sponsor)		 Radiation Retinopathy, Visual Impairment
Related terms Vision Disorders
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov