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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Vantage Biosciences Ltd
Study ID
NCT06770933
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VX-01 — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 11, 2025
Status verified
Jun 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VX-01
    Cohort 1 will include 50 subjects who will be randomized to take investigational drug VX-01 (film-coated tablets) at dose of 150 mg, administered BID.
  • Placebo Comparator: Placebo
    Cohort 2 will include 50 subjects who will be randomized to receive the placebo drug (film-coated tablets), that will be administered BID.

Primary Outcome Measure

Evaluate the efficacy of oral doses of VX-01 in subjects compared to placebo following 1 year of treatment. [ Time Frame: From enrollment to the end of treatment at week 52 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
Stanford Byers Eye InstitutePalo AltoCalifornia94303-
California Retina Consultants- Santa BarbaraSanta BarbaraCalifornia93103-
Florida Retina Institute - Jacksonville SouthsideJacksonvilleFlorida32216-
Retina AssociatesElmhurstIllinois60126-
Cumberland Valley Retina ConsultantsHagerstownMaryland21740-5940-
Erie Retina ResearchEriePennsylvania16507-
Piedmont Eye CenterLynchburgVirginia24502-

Find similar trials in Beverly Hills, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retina-Vitreous Associates Medical Group· Beverly Hills, CAStanford Byers Eye Institute· Palo Alto, CACalifornia Retina Consultants- Santa Barbara· Santa Barbara, CAFlorida Retina Institute - Jacksonville Southside· Jacksonville, FLRetina Associates· Elmhurst, ILCumberland Valley Retina Consultants· Hagerstown, MD

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