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A Study of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME

Study acronym: BAROLO
StatusActive, Not Recruiting
PhasePhase 2/3
Started
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Record History

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  1. Interventions modified Show 4 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 6 of 11 entries
    • Study description revised
    • Study title expanded, about 1 word
  2. Secondary endpoints: 13 to 11v11
  3. Primary endpoint(s) modified
    • Secondary endpoints: 2 to 13
    • Study description expanded, about 14 words
    • Eligibility criteria expanded, about 4 words
    v10
  4. Primary completion date: Jun 30, 2028 to Mar 1, 2027
    • Study completion date: Jun 30, 2028 to Mar 30, 2028
    v9
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 960 to confirmed 1054
    • Site details revised at 164 of 164 sites
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 135 to 164v7
  2. Study sites: 130 to 135v6
  3. Study sites: 117 to 130v5
  4. Study sites: 93 to 117v4
  5. Study sites: 83 to 93v3
  6. Study sites: 39 to 83v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
EYE-RES-103 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of remigromig (EYE103) in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME). In the first year, all 3 treatment groups will be treated every 4 weeks with either remigromig or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm. Approximately 960 participants will be entered in the study.
Trial Details
NCT Number NCT06957080
Lead Sponsor EyeBiotech Ltd.
Conditions
(from sponsor)		 Diabetic Macular Edema (DME)
Enrollment 1,054 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov