A Phase II, Double-Masked, Randomised, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Orally Administered VX-01 in Diabetic Retinopathy OF Non-Proliferative Type (NPDR)
Vantage Biosciences Ltd
Summary
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.
Description
This is a Phase 2, multi-center, double-masked, randomized, placebo-controlled, parallel group study to evaluate the efficacy of oral doses of VX-01 in subjects with moderate to severe NPDR, without CI-DME. Approximately 100 male and female subjects aged ≥ 18 years with a documented diagnosis of Type 1 Diabetic Mellitus or Type 2 Diabetic Mellitus with moderate to severe NPDR (without CI-DME) will be enrolled, if they meet all the eligibility criteria for the study. Subjects will be randomized 1:1 to 1 of 2 study cohorts: * Cohort 1 (n = 50): VX-01 (film-coated tablets, 150 mg administered…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Written informed consent must be obtained from the subject prior to any study-related procedures. * Subject must be aged \> 18 years at the time of Screening. * Subject must have a body mass index (BMI) of between 18 and 40 kg/m2, inclusive. * Subject has a documented diagnosis of T1DM or T2DM. * Subject has moderate to severe NPDR, as determined by a Central Reading Centre (CRC) using DRSS in at least one eye * Subject must have clear ocular media and be able to undergo adequate pupil dilation to allow adequate fundus imaging of both eyes. * Female subject must be eithe…
Interventions
- DrugVX-01
There is no physical difference in VX-01 and the placebo. The only difference lies in active ingredient found in VX-01, which is the compound that will be evaluated in the course of this study.
- DrugPlacebo
Placebo will be supplied as a tablet identical to test drug but without VX-01. Placebo packaging will be identical to IP in order to keep study personnel and subjects masked.
Locations (26)
- Retina-Vitreous Associates Medical GroupBeverly Hills, California
- Stanford Byers Eye InstitutePalo Alto, California
- California Retina Consultants- Santa BarbaraSanta Barbara, California
- Florida Retina Institute - Jacksonville SouthsideJacksonville, Florida
- Retina AssociatesElmhurst, Illinois
- Cumberland Valley Retina ConsultantsHagerstown, Maryland