Phase 2 Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Non-proliferative Diabetic Retinopathy

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

OPL-0401-201 is a multicenter study to investigate the efficacy and safety of OPL-0401 in patients with diabetes mellitus (DM) with diabetic retinopathy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Valo Health, Inc.

Criteria

Inclusion Criteria

• Adults ≥ 18 years;

• Diabetes mellitus (type 1, type 2 or other forms);

• Females who are not a woman of childbearing potential (WOCBP) or who agree to use contraception;

• At least one eye with moderately severe to severe NPDR (DRSS levels 47 or 53);

• Patients with diabetic macular edema (DME) may be eligible if they meet protocol specified eligibility criteria;

• Best corrected visual acuity (BCVA) early treatment of diabetes retinopathy study (ETDRS) letter score at screening ≥69 letters (approximate Snellen equivalent of 20/40 or better) in the study eye without CI-DME, or ≥75 letters when CI-DME is present (approximate Snellen equivalent 20/32 or better);

• Anti-vascular endothelial growth factor (VEGF) or any laser treatment is not required nor anticipated in either eye for least 6 months.

Exclusion Criteria:

• Body mass index > 40 kg/m2

• Uncontrolled diabetes mellitus such as hemoglobin A1c (HbA1C) > 10% 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) in the study eye;

• Evidence of retinal neovascularization

• Any previous treatment with focal or grid laser photocoagulation or Pan-Retinal Photocoagulation (PRP);

• History of previously treated DME with fluocinolone acetonide implant (Iluvien®) injection in the study eye

• Visual acuity loss due to an ocular condition that would not improve from 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 4 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 4 months prior to randomization.