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Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity

Study acronym: RoProp
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2025 to Dec 31, 2028 Completion date: Jul 2026 to Dec 31, 2029v13 Show 1 more changeShow less
    • Completion date: Jul 2026 to Dec 31, 2029
  2. Site details revised at 1 of 3 sitesv12
  3. Primary endpoint revised Study sites: 1 to 3 · Completion date: Jun 2026 to Jul 2026 · Eligibility criteria shortened, about 112 words · 1 morev11 Show 4 more changesShow less
    • Study sites: 1 to 3
    • Completion date: Jun 2026 to Jul 2026
    • Eligibility criteria shortened, about 112 words
    • Secondary endpoints: 12 to 8

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Aug 2024 to Dec 2025 Completion date: Nov 2024 to Jun 2026v10 Show 1 more changeShow less
    • Completion date: Nov 2024 to Jun 2026
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jul 2022 to Sep 22, 2022v9 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2022 to Sep 22, 2022
Show 7 earlier versionsHide 7 earlier versions
  1. Lead sponsor: Charite University, Berlin, Germany to University of Zurich Trial status: Withdrawn to Not Yet Recruiting · Primary completion date: Aug 3, 2023 to Aug 2024 · Start date: Jun 15, 2021 to Jul 2022 · 7 morev8 Show 10 more changesShow less
    • Trial status: Withdrawn to Not Yet Recruiting
    • Primary completion date: Aug 3, 2023 to Aug 2024
    • Start date: Jun 15, 2021 to Jul 2022
    • Primary endpoint revised
    • Enrollment target: 0 to 276
    • Completion date: Nov 3, 2023 to Nov 2024
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints: 1 to 12
    • Collaborators: 3 to 2
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Withdrawn Sponsor's reason: COVID19-related suspension, recruitment goal cannot be met within time limit of funders Enrollment target: estimated 276 to confirmed 0v7 Show 1 more changeShow less
    • Enrollment target: estimated 276 to confirmed 0
  3. Primary completion date: Aug 3, 2022 to Aug 3, 2023 Start date: May 3, 2020 to Jun 15, 2021 · Completion date: Nov 3, 2022 to Nov 3, 2023v6 Show 2 more changesShow less
    • Start date: May 3, 2020 to Jun 15, 2021
    • Completion date: Nov 3, 2022 to Nov 3, 2023
  4. Primary completion date: Nov 3, 2021 to Aug 3, 2022 Start date: Sep 3, 2019 to May 3, 2020 · Completion date: Jul 3, 2022 to Nov 3, 2022v5 Show 2 more changesShow less
    • Start date: Sep 3, 2019 to May 3, 2020
    • Completion date: Jul 3, 2022 to Nov 3, 2022
  5. Primary completion date: Nov 3, 2020 to Nov 3, 2021 Start date: Apr 3, 2019 to Sep 3, 2019 · Completion date: Mar 3, 2021 to Jul 3, 2022v4 Show 2 more changesShow less
    • Start date: Apr 3, 2019 to Sep 3, 2019
    • Completion date: Mar 3, 2021 to Jul 3, 2022
  6. Start date: Apr 2018 to Apr 3, 2019 Primary completion date: Jul 2020 to Nov 3, 2020 · Completion date: Nov 2020 to Mar 3, 2021 · Publications: details revised at 2 of 2 entriesv3 Show 3 more changesShow less
    • Primary completion date: Jul 2020 to Nov 3, 2020
    • Completion date: Nov 2020 to Mar 3, 2021
    • Publications: details revised at 2 of 2 entries
  7. Start date: Jan 2018 to Apr 2018 Primary completion date: May 2020 to Jul 2020 · Completion date: Aug 2020 to Nov 2020 · Eligibility criteria expanded, about 159 words · 1 morev2 Show 4 more changesShow less
    • Primary completion date: May 2020 to Jul 2020
    • Completion date: Aug 2020 to Nov 2020
    • Eligibility criteria expanded, about 159 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  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.
Extremely premature infants are at risk of developing a potentially blinding eye disease, called retinopathy of prematurity (ROP). Currently available treatment, consisting of laser surgery or injection of drugs into the eye balls, may prevent most but not all cases of permanent ROP-mediated blindness. Both types of treatment are associated with significant costs and side effects. An orally administered drug commonly used to treat hypertension, propranolol, may be effective in halting progression of ROP to severe stages, as suggested by preliminary data from small studies. As severe (threshold) ROP is an overall rare disease, the effectiveness of propranolol in combating ROP can only be assessed in a large, multicenter randomized controlled trial involving hospitals caring for extremely preterm infants of diverse origin.
Trial Details
NCT Number NCT03083431
Lead Sponsor University of Zurich
Collaborators: Ankara University, University Hospital Tuebingen
Conditions Retinopathy of Prematurity
Enrollment 276 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov