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

NCT05393284 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: OPL-0401-201
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 25

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.

Conditions

Non-proliferative Diabetic Retinopathy; Proliferative Diabetic Retinopathy

Keywords

diabetic retinopathy; diabetic macular edema; Non-proliferative Diabetic Retinopathy; Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Proportion of patients with an improvement or worsening in DRSS

  12 Weeks/84 days and 24 Weeks/168 days

• Safety and tolerability

  198 days

Study Arms (2)

OPL-0401 Dose 1

EXPERIMENTAL

Participants are randomized to OPL-0401 Dose 1 twice daily for 24 weeks

Drug: OPL-0401 Dose 1

Placebo

PLACEBO COMPARATOR

Participants are randomized to matching Placebo twice daily for 24 weeks

Drug: Placebo

Interventions

OPL-0401 Dose 1 DRUG

Pharmaceutical Form: Capsule; Route of Administration: Oral

OPL-0401 Dose 1

Placebo DRUG

Pharmaceutical Form: Capsule; Route of Administration: Oral

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Valo Health, Inc.: lead

Study Sites (25)

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

Retina Consultants of Southern California

Riverside, California, 92503, United States

Location

Southern California Permanente Medical Group

Riverside, California, 92505, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95825, United States

Location

California Retina Consultants

Santa Barbara, California, 93036, United States

Location

Panorama Eye Care, LLC

Fort Collins, Colorado, 80528, United States

Location

Mid Florida Eye Center

Mt. Dora, Florida, 32757, United States

Location

Eye Associates of Northeast Louisiana

West Monroe, Louisiana, 71291, United States

Location

The Retina Care Center

Baltimore, Maryland, 21209, United States

Location

Massachussetts Eye and Ear

Boston, Massachusetts, 02114, United States

Location

Retina Associates of Michigan

Grand Blanc, Michigan, 48439, United States

Location

Vision Research Center Eye Associates of New Mexico

Albuquerque, New Mexico, 87102-3657, United States

Location

North Carolina Retina Associates

Wake Forest, North Carolina, 27587, United States

Location

Charleston Neuroscience Institute

Ladson, South Carolina, 29456, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Austin Clinical Research, LLC

Austin, Texas, 78750, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

Location

Austin Retina Associates - Round Rock

Round Rock, Texas, 78681, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas

The Woodlands, Texas, 77384, United States

Location

Strategic Clinical Research Group LLC

Willow Park, Texas, 79606-1224, United States

Location

Retina Associates of Utah

Salt Lake City, Utah, 84107, United States

Location

Pacific Northwest Retina

Seattle, Washington, 98104, United States

Location

Spokane Eye Clinical Research

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Victor Shi, M.D.

  Valo Health, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-masked study in which participants, care providers, central reading center and investigators are masked to study intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study 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 non-proliferative diabetic retinopathy (NPDR) or mild PDR with or without diabetic macular edema (DME). Data from an interim analysis may be used to consider additional arms in the study.

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 26, 2022
• Study Start: August 16, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

US (25)