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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Proliferative Diabetic Retinopathy; Non-proliferative Diabetic Retinopathy
• Intervention / Treatment: Drug: OPL-0401 Dose 1; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Mountain View, California, United States, 94040
      • Northern California Retina Vitreous Associates
    • Riverside, California, United States, 92505
      • Southern California Permanente Medical Group
    • Riverside, California, United States, 92503
      • Retina Consultants of Southern California
    • Sacramento, California, United States, 95825
      • Retinal Consultants Medical Group
    • Santa Barbara, California, United States, 93036
      • California Retina Consultants
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • Panorama Eye Care, LLC
  • Florida
    • Mount Dora, Florida, United States, 32757
      • Mid Florida Eye Center
  • Louisiana
    • West Monroe, Louisiana, United States, 71291
      • Eye Associates of Northeast Louisiana
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • The Retina Care Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachussetts Eye and Ear
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Retina Associates of Michigan
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102-3657
      • Vision Research Center Eye Associates of New Mexico
  • North Carolina
    • Wake Forest, North Carolina, United States, 27587
      • North Carolina Retina Associates
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Charleston Neuroscience Institute
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Retina Associates
    • Austin, Texas, United States, 78750
      • Austin Clinical Research, LLC
    • Dallas, Texas, United States, 75231
      • Texas Retina Associates
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute, PA
    • Round Rock, Texas, United States, 78681
      • Austin Retina Associates - Round Rock
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Associates
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Texas
    • Willow Park, Texas, United States, 79606-1224
      • Strategic Clinical Research Group LLC
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Retina Associates of Utah
  • Washington
    • Seattle, Washington, United States, 98104
      • Pacific Northwest Retina
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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) 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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OPL-0401 Dose 1; Participants are randomized to OPL-0401 Dose 1 twice daily for 24 weeks	Drug: OPL-0401 Dose 1; Pharmaceutical Form: Capsule; Route of Administration: Oral
Placebo Comparator: Placebo; Participants are randomized to matching Placebo twice daily for 24 weeks	Drug: Placebo; Pharmaceutical Form: Capsule; Route of Administration: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Diabetic Retinopathy Severity Scale (DRSS) score	Proportion of patients with a ≥2-step improvement from baseline in DRSS	24 weeks/168 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with an improvement or worsening in DRSS	Proportion of patients with an improvement or worsening from baseline in DRSS of ≥ 1, ≥ 2 and ≥ 3 steps	12 Weeks/84 days and 24 Weeks/168 days
Safety and tolerability	Incidence of Adverse event (AE) and serious adverse events (SAE)	198 days

Collaborators and Investigators

• Sponsor: Valo Health, Inc.
• Investigators: Study Director: Victor Shi, M.D., Valo Health, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Proliferative Diabetic Retinopathy; diabetic macular edema; diabetic retinopathy; Non-proliferative Diabetic Retinopathy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: OPL-0401-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No