A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Mar 2027 → Jul 2027
See other at-risk trials from Vantage Biosciences Ltd

Record History

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  1. Enrollment closed, study ongoing Show 6 more changesShow less
    • Primary completion pushed from Mar 2027 to Jul 2027
    • Study completion pushed from Mar 2027 to Oct 2027
    • Study sites: 26 to 27
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study description expanded, about 2 words
  2. Site details revised at 8 of 26 sitesv3
  3. Study sites: 1 to 26
    • Start date changed from estimate of Jan 2025 to Feb 11, 2025
    v2
  4. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of VX-01 as stand-alone treatment for Diabetic Retinopathy of Non-Proliferative Type (NPDR). The primary objective of the study is to evaluate the efficacy of daily oral doses of VX-01 versus placebo following 52 weeks of treatment.
Trial Details
NCT Number NCT06770933
Lead Sponsor Vantage Biosciences Ltd
Collaborators: Vantage Biosciences Australia Pty Ltd
Conditions
(from sponsor)		 Diabetic Retinopathy, NPDR - Non Proliferative Diabetic Retinopathy
Related terms Diabetic Retinopathy
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov