Non-proliferative Diabetic RetinopathyPhase 2NCT05393284
Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy
A Phase 2 study testing OPL-0401 Dose 1 in people with Non-proliferative Diabetic Retinopathy and Proliferative Diabetic Retinopathy, run by Valo Health, Inc. at 25 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy
- What is being tested?
- OPL-0401 Dose 1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 25 sitesUnited States
- Study dates
- 16 Aug 2022to Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years;
- Diabetes mellitus (type 1, type 2 or other forms);
- Females who are not a woman of childbearing potential (WOCBP) or who agree to use contraception;
- At least one eye with moderately severe to severe NPDR (DRSS levels 47 or 53) or mild PDR (DRSS level 61);
- Patients with or without diabetic macular edema (DME) may be eligible if they meet protocol specified eligibility criteria;
- Best corrected visual acuity (BCVA) early treatment of diabetes retinopathy study (ETDRS) letter score in the study at screening ≥69 letters (approximate Snellen equivalent of 20/40 or better) without CI-DME, or ≥75 letters when CI-DME is present (approximate Snellen equivalent 20/32 or better);
- Anti-vascular endothelial growth factor (VEGF) or any laser treatment is not required nor anticipated in the study eye for least 6 months.
Who cannot join
- Body mass index ≥ 45 kg/m2
- Uncontrolled diabetes mellitus such as hemoglobin A1c (HbA1C) > 11% or patients who are not currently treated for their diabetes;
- Uncontrolled hypertension defined as systolic > 160mmHg or diastolic > 100 mmHg (despite hypertensive medication);
- Proliferative Diabetes Retinopathy (PDR) with the exception of mild PDR (DRSS 61);
- Evidence of retinal neovascularization (with the exception of mild PDR);
- Any previous Diabetic Retinopathy treatment with focal or grid laser photocoagulation or Pan-Retinal Photocoagulation (PRP);
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- History of previously treated DME with fluocinolone acetonide implant (Iluvien®) injection;
- Visual acuity loss due to an ocular condition that would not improve from treatment of DR or resolution of DME (i.e., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition);
- History of vitreoretinal surgery;
- Intraocular surgery in the study eye within 3 months of randomization or anticipated over the course of the study;
- Uncontrolled glaucoma (e.g. visual field loss or defined as (IOP) ≥ 25 mmHg despite treatment with anti-glaucoma medication);
- Evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye /any intraocular inflammation or infection in either eye within 3 months prior to randomization.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Vision Research Center Eye Associates of New Mexico
Albuquerque, New Mexico, 87102-3657
Austin Retina Associates
Austin, Texas, 78705
Austin Clinical Research, LLC
Austin, Texas, 78750
The Retina Care Center
Baltimore, Maryland, 21209
Massachussetts Eye and Ear
Boston, Massachusetts, 02114
Texas Retina Associates
Dallas, Texas, 75231
Panorama Eye Care, LLC
Fort Collins, Colorado, 80528
Retina Associates of Michigan
Grand Blanc, Michigan, 48439
Charleston Neuroscience Institute
Ladson, South Carolina, 29456
Valley Retina Institute, PA
McAllen, Texas, 78503
Northern California Retina Vitreous Associates
Mountain View, California, 94040
Mid Florida Eye Center
Mt. Dora, Florida, 32757
Retina Consultants of Southern California
Riverside, California, 92503
Southern California Permanente Medical Group
Riverside, California, 92505
Austin Retina Associates - Round Rock
Round Rock, Texas, 78681
Retinal Consultants Medical Group
Sacramento, California, 95825
Retina Associates of Utah
Salt Lake City, Utah, 84107
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
California Retina Consultants
Santa Barbara, California, 93036
Pacific Northwest Retina
Seattle, Washington, 98104
Spokane Eye Clinical Research
Spokane, Washington, 99204
Retina Consultants of Texas
The Woodlands, Texas, 77384
North Carolina Retina Associates
Wake Forest, North Carolina, 27587
Eye Associates of Northeast Louisiana
West Monroe, Louisiana, 71291
Strategic Clinical Research Group LLC
Willow Park, Texas, 79606-1224
About this study
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.
Read the detailed description
OPL-0401-201 is a randomized, double-masked, placebo-controlled, multicenter study to investigate the efficacy and safety of OPL-0401 in patients with diabetes mellitus (DM) with NPDR or mild PDR with or without diabetic macular edema (DME).
- Being tested
- OPL-0401 Dose 1, Placebo
- Keywords
- diabetic retinopathy, diabetic macular edema, Non-proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPL-0401 Dose 1Drug
Pharmaceutical Form: Capsule; Route of Administration: Oral
PlaceboDrug
Pharmaceutical Form: Capsule; Route of Administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| OPL-0401 Dose 1 | Experimental | Participants are randomized to OPL-0401 Dose 1 twice daily for 24 weeks Receives: Drug: OPL-0401 Dose 1 |
| Placebo | Placebo comparator | Participants are randomized to matching Placebo twice daily for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Diabetic Retinopathy Severity Scale (DRSS) score
Proportion of patients with a ≥2-step improvement from baseline in DRSS
Measured: 24 weeks/168 days
Secondary outcomes (2)
Proportion of patients with an improvement or worsening in DRSS
Proportion of patients with an improvement or worsening from baseline in DRSS of ≥ 1, ≥ 2 and ≥ 3 steps
Measured: 12 Weeks/84 days and 24 Weeks/168 days
Safety and tolerability
Incidence of Adverse event (AE) and serious adverse events (SAE)
Measured: 198 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start16 Aug 2022
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized, double-masked, placebo-controlled, multicenter study to investigate the efficacy and safety of OPL-0401 in patients with diabetes mellitus (DM) with non-proliferative diabetic retinopathy (NPDR) or mild PDR with or without diabetic macular edema (DME). Data from an interim analysis may be used to consider additional arms in the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valo Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victor Shi, M.D., Study director, Valo Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393284
- Sponsor's protocol ID
- OPL-0401-201
- Status last verified
- Jun 2024
- First submitted
- 23 May 2022
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT05393284
- Acronym / sponsor ID
- OPL-0401-201
- Keywords
- diabetic retinopathy, diabetic macular edema, Non-proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Valo Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OPL-0401-201 is a randomized, double-masked, placebo-controlled, multicenter study to investigate the efficacy and safety of OPL-0401 in patients with diabetes mellitus (DM) with NPDR or mild PDR with or without diabetic macular edema (DME).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized, double-masked, placebo-controlled, multicenter study to investigate the efficacy and safety of OPL-0401 in patients with diabetes mellitus (DM) with non-proliferative diabetic retinopathy (NPDR) or mild PDR with or without diabetic macular edema (DME). Data from an interim analysis may be used to consider additional arms in the study.
| Arm | Type | Receives |
|---|---|---|
| OPL-0401 Dose 1 | Experimental | Drug: OPL-0401 Dose 1Participants are randomized to OPL-0401 Dose 1 twice daily for 24 weeks |
| Placebo | Placebo comparator | Drug: PlaceboParticipants are randomized to matching Placebo twice daily for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults ≥ 18 years;
- Diabetes mellitus (type 1, type 2 or other forms);
- Females who are not a woman of childbearing potential (WOCBP) or who agree to use contraception;
- At least one eye with moderately severe to severe NPDR (DRSS levels 47 or 53) or mild PDR (DRSS level 61);
- Patients with or without diabetic macular edema (DME) may be eligible if they meet protocol specified eligibility criteria;
Key exclusion criteria (12 listed)
- Body mass index ≥ 45 kg/m2
- Uncontrolled diabetes mellitus such as hemoglobin A1c (HbA1C) > 11% or patients who are not currently treated for their diabetes;
- Uncontrolled hypertension defined as systolic > 160mmHg or diastolic > 100 mmHg (despite hypertensive medication);
- Proliferative Diabetes Retinopathy (PDR) with the exception of mild PDR (DRSS 61);
- Evidence of retinal neovascularization (with the exception of mild PDR);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPL-0401 Dose 1Pharmaceutical Form: Capsule; Route of Administration: Oral | Drug | OPL-0401 Dose 1 |
| PlaceboPharmaceutical Form: Capsule; Route of Administration: Oral | Drug | Placebo |
Primary outcome
Improvement in Diabetic Retinopathy Severity Scale (DRSS) score
Time frame: 24 weeks/168 days
Proportion of patients with a ≥2-step improvement from baseline in DRSS
2 secondary outcomes
Proportion of patients with an improvement or worsening in DRSS
Time frame: 12 Weeks/84 days and 24 Weeks/168 days
Safety and tolerability
Time frame: 198 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Shi, M.D. study director
Valo Health, Inc.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OPL-0401 Dose 1 in people with Non-proliferative Diabetic Retinopathy and Proliferative Diabetic Retinopathy, run by Valo Health, Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Diabetic Retinopathy Severity Scale (DRSS) score (time frame: 24 weeks/168 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024; AzTrials last refreshed its copy on 30 Oct 2026.