A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Trial sites expanded: 7 → 10 locations
    • Eligibility criteria expanded, about 7 words
  2. Primary completion date: Oct 31, 2025 to Mar 31, 2027v3 Show 6 more changesShow less
    • Study sites: 2 to 7
    • Study completion date: Feb 28, 2026 to May 31, 2027
    • Start date changed from estimate of Dec 18, 2024 to Dec 20, 2024
    • Interventions: THN391 MAD (Drug) to THN391 (Drug)
    • Study arms: 1 to 3
    • Collaborators expanded, about 3 words
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 25, 2024 to Dec 18, 2024
    • Site details revised at 2 of 2 sites
    v2
  4. Study First Submitted
  • 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.
THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.
Trial Details
NCT Number NCT06701721
Lead Sponsor Therini Bio Pty Ltd
Collaborators: Therini Bio, Inc.
Conditions
(from sponsor)		 Diabetic Macular Edema, Diabetic Retinopathy
Related terms Diabetic Retinopathy
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov