OPL-0401 for Diabetic Retinopathy

(Spectra Trial)

Recruiting at 25 trial locations

Overseen By Courtney Ewert

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Valo Health, Inc.

Disqualifiers: Uncontrolled diabetes, Hypertension, PDR, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

114 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that your diabetes and blood pressure should be controlled, which might require continuing your current treatments.

Research Team

Victor Shi, M.D.

Principal Investigator

Valo Health, Inc.

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 don't need nor expect to need eye treatments for blood vessel growth for 6 months.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive OPL-0401 or placebo twice daily for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• OPL-0401
• Placebo

Trial Overview 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.

Participant Groups

Group I: OPL-0401 Dose 1 Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Participants are randomized to matching Placebo twice daily for 24 weeks

Who Is Running the Clinical Trial?

Valo Health, Inc.

Lead Sponsor

Trials

2

Recruited

110+