NCT06770933 · Vantage Biosciences Ltd
A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01
What this study is about
The goal of this clinical trial is to evaluate the effectiveness, safety, how the drug moves through the body (PK) and how the drug affects the body (PD) of VX-01 as stand-alone treatment for Diabetic Retinopathy of Non-Proliferative Type (NPDR).
View original scientific description
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.
Interventions
DRUG
VX-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.
DRUG
Placebo
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.
Primary outcome measures
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
The endpoint of this objective is the proportion of subjects who do not develop a worsening from Baseline in binocular ETDRS DRSS at Week 52. The diabetic retinopathy severity scale (DRSS) is a scale healthcare professionals use to measure the severity and progression of a person's diabetic retinopathy. The main DRSS is the Early Treatment Diabetic Retinopathy Study (ETDRS) scale which will be used in this study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 either: 1. Of non-childbearing potential: post-menopausal or documented surgically sterile post hysterectomy (at least 1 month prior to Screening) 2. Or, if of childbearing potential, must have a negative serum pregnancy test at Screening and must use 2 acceptable forms of contraception, starting at Screening and throughout the study period and for 28 days after the final IP administration.
Where
- Beverly Hills, California
- Palo Alto, California
- Santa Barbara, California
- Jacksonville, Florida
- Elmhurst, Illinois
- Hagerstown, Maryland
- Erie, Pennsylvania
- Lynchburg, Virginia
Collaborators
Vantage Biosciences Australia Pty Ltd
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2025 · Source of record for eligibility and locations