Trials / Active Not Recruiting
Active Not RecruitingNCT05393284
Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- Valo Health, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
OPL-0401-201 is a multicenter study to investigate the safety and efficacy of OPL-0401 in patients with diabetes mellitus (DM) with diabetic retinopathy.
Detailed description
OPL-0401-201 is a randomized, double-masked, placebo-controlled, multicenter study to investigate the efficacy and safety of OPL-0401 in patients with diabetes mellitus (DM) with NPDR or mild PDR with or without diabetic macular edema (DME).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPL-0401 Dose 1 | Pharmaceutical Form: Capsule; Route of Administration: Oral |
| DRUG | Placebo | Pharmaceutical Form: Capsule; Route of Administration: Oral |
Timeline
- Start date
- 2022-08-16
- Primary completion
- 2024-08-01
- Completion
- 2024-08-01
- First posted
- 2022-05-26
- Last updated
- 2024-06-17
Locations
25 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05393284. Inclusion in this directory is not an endorsement.