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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Non-proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy

In brief

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.

Key facts

Study ID

NCT05393284

Run by

Valo Health, Inc.

People needed

114

Starts

2022-08-16

Expected to finish

2024-08-01

Last updated by the study team

2024-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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) or mild PDR (DRSS level 61);
• Patients with or without 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 in the study at screening ≥69 letters (approximate Snellen equivalent of 20/40 or better) 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 the study eye for least 6 months.

You may not qualify if…

• 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.

Where it is running

• 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 — Mt. 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
• Retina Associates of Michigan — Grand Blanc, Michigan, United States
• Vision Research Center Eye Associates of New Mexico — Albuquerque, New Mexico, United States
• North Carolina Retina Associates — Wake Forest, North Carolina, United States
• Charleston Neuroscience Institute — Ladson, South Carolina, United States
• Austin Retina Associates — Austin, Texas, United States
• Austin Clinical Research, LLC — Austin, Texas, United States
• Texas Retina Associates — Dallas, Texas, United States
• Valley Retina Institute, PA — McAllen, Texas, United States
• Austin Retina Associates - Round Rock — Round Rock, Texas, United States
• Medical Center Ophthalmology Associates — San Antonio, Texas, United States
• Retina Consultants of Texas — The Woodlands, Texas, United States
• Strategic Clinical Research Group LLC — Willow Park, Texas, United States
• Retina Associates of Utah — Salt Lake City, Utah, United States
• Pacific Northwest Retina — Seattle, Washington, United States
• Spokane Eye Clinical Research — Spokane, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.