OPL-0401 for Diabetic Retinopathy
(Spectra Trial)

Recruiting in Palo Alto (17 mi)

+25 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Valo Health, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new treatment called OPL-0401 to help people with diabetes who have eye problems. It focuses on patients with diabetic retinopathy, aiming to see if the treatment can reduce eye damage and improve or preserve their vision.

Eligibility Criteria

This trial is for adults over 18 with diabetic retinopathy, a condition affecting the retina due to diabetes. Participants can have mild vision impairment but must not be extremely overweight or have uncontrolled diabetes or blood pressure. They shouldn't need other eye treatments for 6 months and haven't had recent eye surgery or certain past treatments like laser photocoagulation.

Inclusion Criteria

My vision, with correction, is at least 20/40 or better without diabetic macular edema, or 20/32 with it.

I am not able to have children or I agree to use birth control.

I am 18 years old or older.

+6 more

Exclusion Criteria

I have had DME treated with an Iluvien injection before.

My vision loss won't improve with standard diabetic eye disease treatments.

I have had surgery on the back part of my eye.

+9 more

Participant Groups

The study tests OPL-0401's safety and effectiveness in treating diabetic retinopathy compared to a placebo. It's given to people with varying severity of this eye disease, who are then monitored to see if their condition improves without requiring additional procedures.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: OPL-0401 Dose 1Experimental Treatment1 Intervention

Participants are randomized to OPL-0401 Dose 1 twice daily for 24 weeks

Group II: PlaceboPlacebo Group1 Intervention

Participants are randomized to matching Placebo twice daily for 24 weeks