Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy
- Conditions
- Non-proliferative Diabetic RetinopathyProliferative Diabetic Retinopathy
- Interventions
- Drug: OPL-0401 Dose 1Drug: Placebo
- Registration Number
- NCT05393284
- Lead Sponsor
- Valo Health, Inc.
- Brief 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 114
Not provided
- Body mass index ≥ 45 kg/m2
- Uncontrolled diabetes mellitus such as hemoglobin A1c (HbA1C) > 11% or patients who are not currently treated for their diabetes;
- Uncontrolled hypertension defined as systolic > 160mmHg or diastolic > 100 mmHg (despite hypertensive medication);
- Proliferative Diabetes Retinopathy (PDR) with the exception of mild PDR (DRSS 61);
- Evidence of retinal neovascularization (with the exception of mild PDR);
- Any previous Diabetic Retinopathy treatment with focal or grid laser photocoagulation or Pan-Retinal Photocoagulation (PRP);
- History of previously treated DME with fluocinolone acetonide implant (Iluvien®) injection;
- Visual acuity loss due to an ocular condition that would not improve from treatment of DR or resolution of DME (i.e., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition);
- History of vitreoretinal surgery;
- Intraocular surgery in the study eye within 3 months of randomization or anticipated over the course of the study;
- Uncontrolled glaucoma (e.g. visual field loss or defined as (IOP) ≥ 25 mmHg despite treatment with anti-glaucoma medication);
- Evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye /any intraocular inflammation or infection in either eye within 3 months prior to randomization.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OPL-0401 Dose 1 OPL-0401 Dose 1 Participants are randomized to OPL-0401 Dose 1 twice daily for 24 weeks Placebo Placebo Participants are randomized to matching Placebo twice daily for 24 weeks
- Primary Outcome Measures
Name Time Method Improvement in Diabetic Retinopathy Severity Scale (DRSS) score 24 weeks/168 days Proportion of patients with a ≥2-step improvement from baseline in DRSS
- Secondary Outcome Measures
Name Time Method Proportion of patients with an improvement or worsening in DRSS 12 Weeks/84 days and 24 Weeks/168 days Proportion of patients with an improvement or worsening from baseline in DRSS of ≥ 1, ≥ 2 and ≥ 3 steps
Safety and tolerability 198 days Incidence of Adverse event (AE) and serious adverse events (SAE)
Trial Locations
- Locations (25)
Northern California Retina Vitreous Associates
🇺🇸Mountain View, California, United States
Retina Consultants of Southern California
🇺🇸Riverside, California, United States
Southern California Permanente Medical Group
🇺🇸Riverside, California, United States
Retinal Consultants Medical Group
🇺🇸Sacramento, California, United States
California Retina Consultants
🇺🇸Santa Barbara, California, United States
Panorama Eye Care, LLC
🇺🇸Fort Collins, Colorado, United States
Mid Florida Eye Center
🇺🇸Mount Dora, Florida, United States
Eye Associates of Northeast Louisiana
🇺🇸West Monroe, Louisiana, United States
The Retina Care Center
🇺🇸Baltimore, Maryland, United States
Massachussetts Eye and Ear
🇺🇸Boston, Massachusetts, United States
Scroll for more (15 remaining)Northern California Retina Vitreous Associates🇺🇸Mountain View, California, United States