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Bevacizumab Treatment For Type 1 ROP

Study acronym: ROP4
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv25
  2. Primary completion date: Aug 5, 2025 to Jul 1, 2025
    • Study completion date: Jul 2027 to Jul 1, 2027
    • Start date: May 18, 2022 to May 1, 2022
    v24
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 80 to confirmed 77
    • Primary completion date changed from estimate of Jul 2025 to Aug 5, 2025
    • Site details revised at 26 of 26 sites
    v23
  4. 2 versions Re-verified since May 6, 2025, no change to tracked fieldsv21-v22
  5. Study sites: 36 to 26v20
Show 18 earlier versionsHide 18 earlier versions
  1. Primary completion date: Apr 2025 to Jul 2025
    • Study completion date: Dec 2026 to Jul 2027
    v19
  2. 3 versions Re-verified since Feb 5, 2024, no change to tracked fieldsv16-v18
  3. Primary completion date: Dec 2023 to Apr 2025
    • Study completion date: Jun 2024 to Dec 2026
    • Study title shortened, about 1 word
    v15
  4. Eligibility criteria shortened, about 133 words
    • Site details revised at 10 of 36 sites
    v14
  5. Re-verified, no change to tracked fieldsv13
  6. Primary completion date: May 2023 to Dec 2023
    • Study completion date: Apr 2024 to Jun 2024
    • Start date changed from estimate of Jun 2022 to May 18, 2022
    • Site details revised at 2 of 36 sites
    v12
  7. Start date: May 2022 to Jun 2022v11
  8. Start date: Mar 2022 to May 2022
    • Study sites: 35 to 36
    v10
  9. Start date: Nov 2021 to Mar 2022v9
  10. Start date: Oct 18, 2021 to Nov 2021v8
  11. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 35
    • Start date: Oct 2021 to Oct 18, 2021
    v7
  12. Start date: Aug 2021 to Oct 2021v6
  13. Re-verified, no change to tracked fieldsv5
  14. Start date: May 2021 to Aug 2021v4
  15. Start date: Apr 2021 to May 2021v3
  16. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab compared with the standard dose. The current study will evaluate whether doses of 0.063 mg and 0.25mg are effective as treatment for type 1 ROP, with ROP and retinal vessels all in zone I.
Trial Details
NCT Number NCT04634578
Lead Sponsor Jaeb Center for Health Research
Collaborators: Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
Conditions
(from sponsor)		 Retinopathy of Prematurity
Related terms Retinopathy of Prematurity
Enrollment 77 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov