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

Sponsor

Valo Health, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05393284

Collaborator

(none)

120

Enrollment

Locations

Arms

18.5

Anticipated Duration (Months)

17.1

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

OPL-0401-201 is a multicenter study to investigate the efficacy and safety of OPL-0401 in patients with diabetes mellitus (DM) with diabetic retinopathy.

Condition or Disease	Intervention/Treatment	Phase
Non-proliferative Diabetic Retinopathy	Drug: OPL-0401 Dose 1 Drug: OPL-0401 Dose 2 Drug: Placebo	Phase 2

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 non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME), or with NPDR with DME and good visual acuity (VA).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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) without diabetic macular edema (DME), or with NPDR with DME and good visual acuity (VA). Data from an interim analysis may be used to consider additional arms in the study.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) without diabetic macular edema (DME), or with NPDR with DME and good visual acuity (VA). Data from an interim analysis may be used to consider additional arms in the study.

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

This is a double-masked study in which participants, care providers, and investigators are masked to study intervention.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 16, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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
Experimental: OPL-0401 Dose 2 Participants are randomized to OPL-0401 Dose 2 twice daily for 24 weeks	Drug: OPL-0401 Dose 2 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

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

Experimental: OPL-0401 Dose 2

Participants are randomized to OPL-0401 Dose 2 twice daily for 24 weeks

Drug: OPL-0401 Dose 2

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

Outcome Measures

Primary Outcome Measures

Improvement in Diabetic Retinopathy Severity Scale (DRSS) score [24 weeks/168 days]
Proportion of patients with a ≥2-step improvement from baseline in DRSS

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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);
Patients with 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 at screening ≥69 letters (approximate Snellen equivalent of 20/40 or better) in the study eye 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 either eye for least 6 months.

Exclusion Criteria:

Body mass index > 40 kg/m2
Uncontrolled diabetes mellitus such as hemoglobin A1c (HbA1C) > 10% 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) in the study eye;
Evidence of retinal neovascularization
Any previous treatment with focal or grid laser photocoagulation or Pan-Retinal Photocoagulation (PRP);
History of previously treated DME with fluocinolone acetonide implant (Iluvien®) injection in the study eye
Visual acuity loss due to an ocular condition that would not improve from 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 4 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 4 months prior to randomization.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Retina Consultants	Santa Barbara	California	United States	93036
2	Panorama Eye Care, LLC	Fort Collins	Colorado	United States	80528
3	Eye Associates of Northeast Louisiana	West Monroe	Louisiana	United States	71291
4	Austin Retina Associates	Austin	Texas	United States	78705
5	Austin Clinical Research, LLC	Austin	Texas	United States	78750
6	Texas Retina Associates	Dallas	Texas	United States	75231
7	Retina Consultants of Texas	The Woodlands	Texas	United States	77384

Sponsors and Collaborators

Valo Health, Inc.

Investigators

Study Director: Philip Yin, M.D., Ph.D., Valo Health, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Valo Health, Inc.

ClinicalTrials.gov Identifier:

NCT05393284

Other Study ID Numbers:

OPL-0401-201

First Posted:

May 26, 2022

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Valo Health, Inc.

diabetic retinopathy

diabetic macular edema

Additional relevant MeSH terms:

Retinal Diseases

Diabetic Retinopathy

Study Results

No Results Posted as of Aug 22, 2022