Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy
NCT ID: NCT05393284
Last Updated: 2024-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
114 participants
INTERVENTIONAL
2022-08-16
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OPL-0401 Dose 1
Participants are randomized to OPL-0401 Dose 1 twice daily for 24 weeks
OPL-0401 Dose 1
Pharmaceutical Form: Capsule; Route of Administration: Oral
Placebo
Participants are randomized to matching Placebo twice daily for 24 weeks
Placebo
Pharmaceutical Form: Capsule; Route of Administration: Oral
Interventions
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OPL-0401 Dose 1
Pharmaceutical Form: Capsule; Route of Administration: Oral
Placebo
Pharmaceutical Form: Capsule; Route of Administration: Oral
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Valo Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Victor Shi, M.D.
Role: STUDY_DIRECTOR
Valo Health, Inc.
Locations
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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
Countries
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Other Identifiers
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OPL-0401-201
Identifier Type: -
Identifier Source: org_study_id
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