Clinical trial NCT05393284: Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy
Official title: Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-proliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy
Keywords: diabetic retinopathy
diabetic macular edema
Non-proliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy
Lead sponsor: Valo Health, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-26
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in Diabetic Retinopathy Severity Scale (DRSS) score
timeFrame: 24 weeks/168 days
Secondary outcomes:
measure: Proportion of patients with an improvement or worsening in DRSS
timeFrame: 12 Weeks/84 days and 24 Weeks/168 days
measure: Safety and tolerability
timeFrame: 198 days
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Riverside
country: United States
facility: Retina Consultants of Southern California
state: California
city: Riverside
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Fort Collins
country: United States
facility: Panorama Eye Care, LLC
state: Colorado
city: Mount Dora
country: United States
facility: Mid Florida Eye Center
state: Florida
city: West Monroe
country: United States
facility: Eye Associates of Northeast Louisiana
state: Louisiana
city: Baltimore
country: United States
facility: The Retina Care Center
state: Maryland
city: Boston
country: United States
facility: Massachussetts Eye and Ear
state: Massachusetts
city: Grand Blanc
country: United States
facility: Retina Associates of Michigan
state: Michigan
city: Albuquerque
country: United States
facility: Vision Research Center Eye Associates of New Mexico
state: New Mexico
city: Wake Forest
country: United States
facility: North Carolina Retina Associates
state: North Carolina
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research, LLC
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute, PA
state: Texas
city: Round Rock
country: United States
facility: Austin Retina Associates - Round Rock
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group LLC
state: Texas
city: Salt Lake City
country: United States
facility: Retina Associates of Utah
state: Utah
city: Seattle
country: United States
facility: Pacific Northwest Retina
state: Washington
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
Study officials:
affiliation: Valo Health, Inc.
name: Victor Shi, M.D.
role: STUDY_DIRECTOR
References: