Trials / Completed
CompletedNCT04265261
A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy
A Randomized, Double-Masked, 48-Week, Parallel-Group, Placebo-Controlled, Proof-of-Concept Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 139 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study's main purpose is to asses the safety, tolerability, and effect of oral administration of RG7774 on the severity of diabetic retinopathy (DR) in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) and good vision.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Participants will receive oral placebo matched to RG7774 |
| DRUG | RG7774 | Participants will receive oral RG7774 |
Timeline
- Start date
- 2020-06-05
- Primary completion
- 2023-07-19
- Completion
- 2023-07-19
- First posted
- 2020-02-11
- Last updated
- 2024-09-25
- Results posted
- 2024-09-25
Locations
68 sites across 7 countries: United States, Australia, Poland, Puerto Rico, Slovakia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04265261. Inclusion in this directory is not an endorsement.