RecruitingPhase 2NCT06770933

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

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)


Sponsor

Vantage Biosciences Ltd

Enrollment

100 participants

Start Date

Feb 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called VX-01 for people with diabetic retinopathy and npdr - non proliferative diabetic retinopathy. The study is currently recruiting participants at 26 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Group

Beverly Hills, California, United States

Stanford Byers Eye Institute

Palo Alto, California, United States

California Retina Consultants- Santa Barbara

Santa Barbara, California, United States

Florida Retina Institute - Jacksonville Southside

Jacksonville, Florida, United States

Retina Associates

Elmhurst, Illinois, United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Erie Retina Research

Erie, Pennsylvania, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

Eye Clinic Albury Wodonga

Albury, New South Wales, Australia

Retina And Eye Consultants Hurstville

Hurstville, New South Wales, Australia

Marsden Eye Specialists

Parramatta, New South Wales, Australia

Sydney Eye Hospital

Sydney, New South Wales, Australia

Sydney Retina Clinic

Sydney, New South Wales, Australia

Sydney West Retina

Westmead, New South Wales, Australia

University of the Sunshine Coast Clinical Trials (Birtinya)

Birtinya, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Prince of Wales Hospital The Chinese University of Hong Kong

Shatin, Hong Kong

HKU Eye Centre

Wong Chuk Hang, Hong Kong

University Malaya Medical Centre

Petaling Jaya, Kuala Lumpur Federal Territory of Kuala Lumpur, Malaysia

Hospital Pulau Pinang

George Town, Pulau Pinang, Malaysia

Hospital Shah Alam

Shah Alam, Selangor, Malaysia

Hospital Al-sultan Abdullah Uitm

Sungai Buloh, Selangor, Malaysia

Hospital Selayang

Selayang Baru Utara, Malaysia

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06770933


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