OPL-0401 for Diabetic Retinopathy

(Spectra Trial)

Not currently recruiting at 26 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called OPL-0401 to determine its safety and effectiveness for people with diabetic retinopathy, a condition where diabetes damages the eyes. Participants will receive either the OPL-0401 treatment or a placebo (a substance with no therapeutic effect) for 24 weeks. The trial seeks individuals with diabetes who have specific levels of eye damage but haven't recently undergone certain eye treatments or surgeries. This offers a chance to potentially improve eye health while contributing to research on diabetic retinopathy. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that OPL-0401 is likely to be safe for humans?

Research has shown that OPL-0401 is generally safe and well-tolerated by users. In earlier studies, certain doses appeared to help prevent diabetic retinopathy, an eye condition related to diabetes. Although exact details on side effects are not available, its continued testing indicates that its safety is deemed sufficient for further research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic retinopathy?

Researchers are excited about OPL-0401 for diabetic retinopathy because it offers a potential new approach to treating this eye condition. Most current treatments involve injections into the eye or laser surgery, which can be invasive and uncomfortable. OPL-0401 is unique as it is taken orally, making it a non-invasive option. Additionally, this treatment may work by targeting specific pathways involved in the disease, which could lead to better outcomes for patients with fewer side effects.

What evidence suggests that OPL-0401 might be an effective treatment for diabetic retinopathy?

In this trial, participants will receive either OPL-0401 or a placebo. Research suggests that OPL-0401 might slow the progression of diabetic retinopathy, an eye problem caused by diabetes. However, one study found that OPL-0401 did not significantly improve the condition compared to a placebo, which contains no active drug. While there are some hopeful signs, the treatment hasn't consistently shown effectiveness. The drug targets a specific process involved in diabetic retinopathy. Overall, results are mixed, with some early signs of potential but no strong proof of effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

Victor Shi, M.D.

Principal Investigator

Valo Health, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. valohealth.com valohealth.com/press/valo-health-announces-topline-results-from-phase-2-spectra-study-of-opl-0401-in-patients-with-diabetic-retinopathy

Valo Health Announces Topline Results from Phase 2 ... OPL-0401 demonstrated favorable safety profile and certain doses tested indicate promise in preventing disease progression.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05393284

Phase 2 Spectra Study to Evaluate the Safety and Efficacy ... OPL-0401-201 is a multicenter study to investigate the safety and efficacy of OPL-0401 in patients with diabetes mellitus (DM) with diabetic retinopathy.

3. firstwordpharma.com firstwordpharma.com/story/5924464

Flagship's computationally driven AI startup hits setback in ... Topline data demonstrated that OPL-0401 failed to achieve a statistically significant improvement in DR severity score compared with placebo, ...

4. ophthalmologymanagement.com ophthalmologymanagement.com/news/2025/valo-health-suspends-development-of-diabetic-retinopathy-drug/

Valo Health Suspends Development of Diabetic ... The study's primary objective was to assess the efficacy of OPL-0401 compared to placebo in improving diabetic retinopathy severity score (DRSS) ...

5. nature.com nature.com/articles/s41433-025-03835-w

New targets in diabetic retinopathy: addressing limitations ... This review summarises Sema3A/Nrp1 pathway involvement in DR and RNP and its role as a potential target to treat DR in the context of current treatment options.

6. withpower.com withpower.com/trial/phase-2-non-proliferative-diabetic-retinopathy-4-2022-acac2

OPL-0401 for Diabetic Retinopathy (Spectra Trial) 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 ...