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NCT06770933 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01
A Phase 2 study of Diabetic Retinopathy and NPDR - Non Proliferative Diabetic Retinopathy, sponsored by Vantage Biosciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT06770933: Recruiting Phase 2 study of Diabetic Retinopathy and NPDR - Non Proliferative Diabetic Retinopathy, sponsored by Vantage Biosciences.
NCT06770933 is a Phase 2 study of Diabetic Retinopathy and NPDR - Non Proliferative Diabetic Retinopathy that is actively recruiting participants, run by Vantage Biosciences. The registered enrollment target is 100 participants, below the 1,675-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06770933, a Phase 2 study of Diabetic Retinopathy and NPDR - Non Proliferative Diabetic Retinopathy, is actively recruiting participants, sponsored by Vantage Biosciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG VX-01
Study Locations (20)
New South Wales
- Eye Clinic Albury Wodonga - Albury
- Retina And Eye Consultants Hurstville - Hurstville
- Marsden Eye Specialists - Parramatta
- Sydney Eye Hospital - Sydney
- Sydney Retina Clinic - Sydney
- Sydney West Retina - Westmead
California
- Retina-Vitreous Associates Medical Group - Beverly Hills
- Stanford Byers Eye Institute - Palo Alto
- California Retina Consultants- Santa Barbara - Santa Barbara
Other
- Prince of Wales Hospital The Chinese University of Hong Kong - Shatin
- HKU Eye Centre - Wong Chuk Hang
Florida
- Florida Retina Institute - Jacksonville Southside - Jacksonville
Illinois
- Retina Associates - Elmhurst
Maryland
- Cumberland Valley Retina Consultants - Hagerstown
Pennsylvania
- Erie Retina Research - Erie
Virginia
- Piedmont Eye Center - Lynchburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-02-11 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
What NCT06770933 shows while recruiting
NCT06770933 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,675-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Diabetic Retinopathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06770933 names 20 study sites across 12 states, led by New South Wales, California, Other.
Frequently Asked Questions
What is clinical trial NCT06770933 about?
NCT06770933 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01". 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-...
What is the current status of trial NCT06770933?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2025-02-11. Estimated completion is 2027-03.
What conditions does trial NCT06770933 study?
This clinical trial studies the following conditions: Diabetic Retinopathy, NPDR - Non Proliferative Diabetic Retinopathy.
What interventions are being tested in trial NCT06770933?
The interventions under investigation include: Placebo (DRUG), VX-01 (DRUG).
Who is sponsoring clinical trial NCT06770933?
This trial is sponsored by Vantage Biosciences, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06770933 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06770933's enrollment target sits among peer trials
100 38th of 57 higher than 20 of 57 other Diabetic Retinopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Retinopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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