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A Study to Evaluate the Efficacy and Safety of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME

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

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  1. Interventions modified
    • Study description revised
    • Study title expanded, about 1 word
  2. Primary completion date changed from estimate of Sep 30, 2026 to Jul 14, 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 6 of 11 entries
    • Site details revised at 2 of 183 sites
  3. Secondary endpoints: 13 to 11v14
  4. Primary endpoint revisedv13 Show 5 more changesShow less
    • Primary completion date: Sep 2026 to Sep 30, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 1 to 13
    • Study description expanded, about 14 words
    • Site details revised at 47 of 183 sites
  5. Primary completion date: Dec 31, 2027 to Sep 2026
    • Enrollment target: estimated 960 to confirmed 984
    • Site details revised at 50 of 183 sites
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 183 of 183 sites
    v11
  2. Study sites: 177 to 183v10
  3. Study sites: 170 to 177v9
  4. Study sites: 123 to 170v8
  5. Start date: Aug 14, 2024 to Aug 7, 2024
    • Site details revised at 11 of 123 sites
    v7
  6. Study sites: 99 to 123v6
  7. Study sites: 69 to 99v5
  8. Study sites: 59 to 69v4
  9. Study sites: 15 to 59v3
  10. Study title shortened, about 2 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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-102 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 NCT06571045
Lead Sponsor EyeBiotech Ltd.
Conditions
(from sponsor)		 Diabetic Macular Edema (DME)
Enrollment 984 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov