Actively Recruiting
A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01
Led by Vantage Biosciences Ltd · Updated on 2025-06-18
100
Participants Needed
26
Research Sites
106 weeks
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
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.
CONDITIONS
Official 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 prior to 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 (NPDR) in at least one eye
- Clear ocular media and ability to have pupil dilation for fundus imaging
- Female participants either non-childbearing or using two forms of contraception with negative pregnancy test
- Female participants not breastfeeding during the study period
- Male participants surgically sterile or using two forms of contraception if sexually active with childbearing potential female
- No donation of ova or sperm during and for 28 days after study
- Best Corrected Visual Acuity (BCVA) of at least 70 letters in study eye and 20 letters in other eye
- Willingness and ability to return for all visits and complete assessments
- Agreement not to participate in other interventional studies during this study period
You will not qualify if you...
- Presence of clinically significant diabetic macular edema threatening the center of the macula or requiring treatment
- Moderate to high-risk proliferative diabetic retinopathy (DRSS level 65 or higher)
- Prior ocular treatments including laser photocoagulation, anti-VEGF agents, steroids, fluocinolone implant, or vitrectomy within specified timeframes
- Active eye infections or inflammation such as uveitis or endophthalmitis
- History of corneal transplant or ocular incisional surgery except cataract or refractive surgery more than 3 months ago
- Uncontrolled glaucoma or advanced glaucoma
- Other significant ocular diseases affecting vision
- Known or suspected allergy to the investigational product
- Uncontrolled diabetes with HbA1c of 12% or higher
- Recent initiation of GLP-1 modulators or intensive insulin treatment
- Use of coumarin anticoagulants
- On dialysis or severely reduced kidney function
- High blood pressure above specified limits
- Resting heart rate outside 50 to 110 bpm
- Chronic liver disease or elevated liver enzymes
- Immunocompromised or on immunosuppressive therapy except low dose corticosteroids
- Current treatment with strong P-glycoprotein inhibitors
- History of allergy to fluorescein
- Any medical condition interfering with participation or study results
- Participation in other investigational studies within 30 days
- Recent severe blood loss, hemoglobinopathy, or severe anemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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