OPL-0401 Dose 1 for Non-proliferative Diabetic Retinopathy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Retina Associates of Utah, Salt Lake City, UT
Non-proliferative Diabetic Retinopathy+2 More
OPL-0401 Dose 1 - Drug
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

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

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
Photo of Salt Lake City 1Photo of Salt Lake City 2Photo of Salt Lake City 3
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 preview

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.