Actively Recruiting
A Phase II Randomized, Double-Masked, Placebo-Controlled Study Evaluating Oral VX-01 for 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants take oral tablets of either VX-01 or placebo twice daily for 52 consecutive weeks.
Regular visits during treatment period
Duration - 12 weeks
Participants are followed for safety and efficacy assessments after completing treatment.
1 to 2 visits for follow-up assessments
Trial Site Locations
Total: 26 locations
1
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Not Yet Recruiting
2
Stanford Byers Eye Institute
Palo Alto, California, United States, 94303
Not Yet Recruiting
3
California Retina Consultants- Santa Barbara
Santa Barbara, California, United States, 93103
Not Yet Recruiting
4
Florida Retina Institute - Jacksonville Southside
Jacksonville, Florida, United States, 32216
Not Yet Recruiting
5
Retina Associates
Elmhurst, Illinois, United States, 60126
Not Yet Recruiting
6
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States, 21740-5940
Not Yet Recruiting
7
Erie Retina Research
Erie, Pennsylvania, United States, 16507
Not Yet Recruiting
8
Piedmont Eye Center
Lynchburg, Virginia, United States, 24502
Not Yet Recruiting
9
Eye Clinic Albury Wodonga
Albury, New South Wales, Australia, 2640
Actively Recruiting
10
Retina And Eye Consultants Hurstville
Hurstville, New South Wales, Australia, 2220
Actively Recruiting
11
Marsden Eye Specialists
Parramatta, New South Wales, Australia, 2150
Actively Recruiting
12
Sydney Eye Hospital
Sydney, New South Wales, Australia, 2000
Actively Recruiting
13
Sydney Retina Clinic
Sydney, New South Wales, Australia, 2000
Actively Recruiting
14
Sydney West Retina
Westmead, New South Wales, Australia, 2145
Actively Recruiting
15
University of the Sunshine Coast Clinical Trials (Birtinya)
Birtinya, Queensland, Australia, 4575
Actively Recruiting
16
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
17
Prince of Wales Hospital The Chinese University of Hong Kong
Shatin, Hong Kong
Actively Recruiting
18
HKU Eye Centre
Wong Chuk Hang, Hong Kong
Not Yet Recruiting
19
University Malaya Medical Centre
Petaling Jaya, Kuala Lumpur Federal Territory of Kuala Lumpur, Malaysia, 59100
Not Yet Recruiting
20
Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia, 10450
Not Yet Recruiting
21
Hospital Shah Alam
Shah Alam, Selangor, Malaysia, 40000
Not Yet Recruiting
22
Hospital Al-sultan Abdullah Uitm
Sungai Buloh, Selangor, Malaysia, 47000
Not Yet Recruiting
23
Hospital Selayang
Selayang Baru Utara, Malaysia
Not Yet Recruiting
24
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Not Yet Recruiting
25
Asan Medical Center
Seoul, South Korea
Not Yet Recruiting
26
Samsung Medical Center
Seoul, South Korea
Not Yet Recruiting
Research Team
S
Steffy George
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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