OPL-0401 Dose 1 for Non-proliferative Diabetic Retinopathy

Phase-Based Progress Estimates

Effectiveness

Safety

Retina Associates of Utah, Salt Lake City, UT

Non-proliferative Diabetic Retinopathy+2 More

OPL-0401 Dose 1 - Drug

You have a chance of qualifying for this trial. We made sure your application will take less than 5 minutes.

Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study 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.

Eligible Conditions

Non-proliferative Diabetic Retinopathy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Non-proliferative Diabetic Retinopathy

Sinemet CR

Aqueous PGE2 and inflammatory cytokines measurements

Brepocitinib

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 12 Weeks/84 days and 24 Weeks/168 days

Week 24

Proportion of patients with an improvement or worsening in DRSS

198 days

Safety and tolerability

24 weeks/168 days

Improvement in Diabetic Retinopathy Severity Scale (DRSS) score

Trial Safety

Safety Progress

2 of 3

This is further along than 68% of similar trials

Other trials for Non-proliferative Diabetic Retinopathy

Sinemet CR

Aqueous PGE2 and inflammatory cytokines measurements

Brepocitinib

Trial Design

3 Treatment Groups

OPL-0401 Dose 1

1 of 3

OPL-0401 Dose 2

1 of 3

Placebo

1 of 3

Experimental Treatment

Non-Treatment Group

120 Total Participants · 3 Treatment Groups

Primary Treatment: OPL-0401 Dose 1 · Has Placebo Group · Phase 2

OPL-0401 Dose 1

Drug

Experimental Group · 1 Intervention: OPL-0401 Dose 1 · Intervention Types: Drug

OPL-0401 Dose 2

Drug

Experimental Group · 1 Intervention: OPL-0401 Dose 2 · Intervention Types: Drug

Placebo

Drug

PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: 12 weeks/84 days and 24 weeks/168 days

Closest Location: Retina Associates of Utah · Salt Lake City, UT

2016First Recorded Clinical Trial

1 TrialsResearching Non-proliferative Diabetic Retinopathy

11 CompletedClinical Trials

Who is running the clinical trial?

Valo Health, Inc.Lead Sponsor

1 Previous Clinical Trials

174 Total Patients Enrolled

Philip Yin, M.D., Ph.D.Study DirectorValo Health, Inc.

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

Diabetes mellitus type 1, type 2 or other forms.

You are female and not a WOCBP.

At least one eye with moderately severe to severe NPDR (DRSS levels 47 or 53).

Anti-VEGF or any laser treatment is not required nor anticipated in either eye for least 6 months.

About The Reviewer

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References