RecruitingDiabetic RetinopathyNPDR - Non Proliferative Diabetic Retinopathy
A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
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.
Sponsor: Vantage Biosciences Ltd
You may qualify if…
- ✓ 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)
You may not qualify if…
- ✕ Ophthalmic:
- ✕ Presence of CI-DME (with central subfield thickness \[CST\] measured greater than 325 μm on spectral domain optical coherence tomography \[SD-OCT\]) threatening the center of the macula (within 1,000 μm of the foveal center) in either eye, or presence of DME requiring treatment.
- ✕ Presence of moderate to high-risk PDR (DRSS level 65 or higher).
- ✕ Any prior treatment (in either eye) with:
- ✕ 1. Focal or grid laser photocoagulation within the past 6 months prior to Screening or pan-retinal photocoagulation (PRP) at any time.
- ✕ 2. Systemic or intravitreal anti-vascular endothelial growth factor (VEGF) agents within the last 12 months prior to Screening.
- ✕ 3. Intraocular, sub-tenon or periocular steroids, including triamcinolone and dexamethasone implant within the last 6 months, or suprachoroidal triamcinolone within the last 3 months prior to Screening.
- ✕ 4. Fluocinolone implant within the last 3 years prior to Screening.
Where it's recruiting
California
Beverly Hills · Palo Alto · Santa Barbara
Florida
Jacksonville
Illinois
Elmhurst
Maryland
Hagerstown
Pennsylvania
Erie
Virginia
Lynchburg
Source: ClinicalTrials.gov · NCT06770933 · last updated 2025-06-18