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

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05393284
• Other study ID #: OPL-0401-201
• Status: Recruiting
• Phase: Phase 2
• Start date: August 16, 2022
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Valo Health, Inc.
• Contact: David Nash
• Phone: 617-329-1884
• Email: ct.gov[@]valohealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 107
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Non-proliferative Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• OPL-0401 Dose 1
Pharmaceutical Form: Capsule; Route of Administration: Oral
• Placebo
Pharmaceutical Form: Capsule; Route of Administration: Oral

Locations

Country	Name	City	State
United States	Vision Research Center Eye Associates of New Mexico	Albuquerque	New Mexico
United States	Austin Clinical Research, LLC	Austin	Texas
United States	Austin Retina Associates	Austin	Texas
United States	The Retina Care Center	Baltimore	Maryland
United States	Massachussetts Eye and Ear	Boston	Massachusetts
United States	Texas Retina Associates	Dallas	Texas
United States	Panorama Eye Care, LLC	Fort Collins	Colorado
United States	Retina Associates of Michigan	Grand Blanc	Michigan
United States	Charleston Neuroscience Institute	Ladson	South Carolina
United States	Valley Retina Institute, PA	McAllen	Texas
United States	Mid Florida Eye Center	Mount Dora	Florida
United States	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	Austin Retina Associates - Round Rock	Round Rock	Texas
United States	Retinal Consultants Medical Group	Sacramento	California
United States	Retina Associates of Utah	Salt Lake City	Utah
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	California Retina Consultants	Santa Barbara	California
United States	Pacific Northwest Retina	Seattle	Washington
United States	Spokane Eye Clinical Research	Spokane	Washington
United States	Retina Consultants of Texas	The Woodlands	Texas
United States	North Carolina Retina Associates	Wake Forest	North Carolina
United States	Eye Associates of Northeast Louisiana	West Monroe	Louisiana
United States	Strategic Clinical Research Group LLC	Willow Park	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Valo Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Safety and tolerability	Incidence of Adverse event (AE) and serious adverse events (SAE)	198 days