Actively Recruiting
Phase 2 Study to Test the Safety and Effectiveness of Oral VX-01 in Adults with Moderate to Severe Non-Proliferative Diabetic Retinopathy
Led by Vantage Biosciences Ltd · Updated on 2025-06-18
100
Participants Needed
26
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Vantage Biosciences Ltd
Lead Sponsor
V
Vantage Biosciences Australia Pty Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of VX-01, an oral medication, to treat people with moderate to severe Non-Proliferative Diabetic Retinopathy NPDR, a condition related to diabetes affecting the eyes. This Phase 2 clinical trial aims to evaluate how effective and safe VX-01 is compared to a placebo over one year of treatment, including how the body processes the drug and its effects on the disease. Participants will be randomly assigned to one of two groups one group will receive VX-01 tablets at a dose of 150 mg twice daily, and the other group will receive placebo tablets twice daily. The treatment period lasts 52 weeks, followed by a 12-week follow-up after treatment ends. The study is double-masked, meaning neither participants nor study staff know which treatment is being taken during the trial. During the study, participants will have their vision and eye health regularly assessed using standardized tests such as the Early Treatment Diabetic Retinopathy Study ETDRS letter score and diabetic retinopathy severity scores. Safety will be monitored by tracking any adverse events. Participants must attend scheduled visits for evaluations and agree to avoid other investigational studies during the trial. The main goal is to see how VX-01 affects diabetic retinopathy after one year of daily treatment.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before any study procedures
- Age over 18 years at screening
- Body mass index between 18 and 40 kg/m2 inclusive
- Documented diagnosis of Type 1 or Type 2 Diabetes Mellitus
- Moderate to severe Non-Proliferative Diabetic Retinopathy in at least one eye
- Clear ocular media allowing adequate pupil dilation for fundus imaging
- For females: either non-childbearing potential or negative pregnancy test and use of two contraception methods during study and 28 days after
- Females must not breastfeed during the study and for 28 days after
- Males must be surgically sterile or use two contraception methods if sexually active with females of childbearing potential
- No donation of ova or sperm during study and for 28 days after
- Best Corrected Visual Acuity of at least 70 letters in study eye and at least 20 letters in the fellow eye
- Ability and willingness to attend all visits and complete assessments
- Agreement not to participate in other interventional studies during the trial
You will not qualify if you...
- Presence of central-involved diabetic macular edema requiring treatment or threatening the macula
- Moderate to high-risk proliferative diabetic retinopathy (DRSS level 65 or higher)
- Prior treatments such as laser photocoagulation, anti-VEGF agents, steroids, vitrectomy, or YAG capsulotomy within specified timeframes
- Active eye infections or inflammation such as uveitis or conjunctivitis
- History of corneal transplant, vitrectomy, or ocular incisional surgery (except older cataract or refractive surgery)
- Uncontrolled glaucoma or advanced glaucoma
- Significant ocular diseases that would interfere with study participation
- Other retinal or macular vascular diseases unrelated to diabetes
- Hypersensitivity or contraindication to the study drug
- Uncontrolled diabetes with HbA1c of 12% or higher
- Recent initiation of GLP-1 modulators or intensive insulin treatment
- Use of coumarin anticoagulants
- Dialysis or severe kidney impairment
- High blood pressure or abnormal heart rate outside specified ranges
- Chronic liver disease or elevated liver enzymes
- Immunocompromised state or use of immunosuppressive therapy
- Use of strong P-glycoprotein inhibitors
- Allergy to fluorescein
- Any medical condition interfering with study participation
- Participation in other investigational studies within 30 days prior to screening
- Recent severe blood loss, hemoglobin disorders, or severe anemia
Research Team
S
Steffy George
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