What side effects are associated with this type of intervention?

Common treatments for diabetic retinopathy, such as anti-VEGF injections, corticosteroids, and laser therapy, have various side effects. Anti-VEGF injections can cause eye pain, vitreous floaters, increased intraocular pressure, and rarely, retinal detachment or endophthalmitis. Corticosteroids may lead to increased intraocular pressure, cataracts, and potential exacerbation of glaucoma. Laser therapy can result in visual field loss, decreased night vision, and potential scarring of the retina. These treatments target vascular damage and metabolic pathways to manage the progression of diabetic retinopathy.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetic retinopathy that target vascular damage and metabolic pathways. Anti-VEGF (vascular endothelial growth factor) agents such as ranibizumab (Lucentis) and aflibercept (Eylea) are commonly used to inhibit abnormal blood vessel growth and reduce vascular permeability. Additionally, corticosteroids like dexamethasone intravitreal implant (Ozurdex) are approved to reduce inflammation and edema. These treatments aim to address the underlying vascular issues associated with diabetic retinopathy, similar to the investigational approach of OPL-0401.

What other types of research exist?

Promising novel alternatives to OPL-0401 for diabetic retinopathy include anti-VEGF therapies such as aflibercept and ranibizumab, which target vascular endothelial growth factor to reduce retinal swelling and improve vision. Additionally, emerging treatments like faricimab, a bispecific antibody targeting both VEGF and Ang-2, and gene therapies such as RGX-314, which aims to provide long-term anti-VEGF effects, are showing potential in clinical trials.

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OPL-0401 for Diabetic Retinopathy (Spectra Trial)

Phase 2

Waitlist Available

Research Sponsored by Valo Health, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Females who are not a woman of childbearing potential (WOCBP) or who agree to use contraception

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks/84 days and 24 weeks/168 days

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of OPL-0401 aren't listed here, similar medications may cause irritation at the injection site, increased intraocular pressure, cataracts, and potential worsening of the condition being treated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I have severe diabetic retinopathy in at least one eye.

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I have diabetes.

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I have diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had DME treated with an Iluvien injection before.

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

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

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My blood pressure is not controlled, even with medication.

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My diabetes is not under control or I am not being treated for it.

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I haven't had eye surgery in the past 3 months nor plan to during the study.

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I have had laser treatment for diabetic eye disease.

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I have glaucoma that isn't controlled by medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks/84 days and 24 weeks/168 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks/84 days and 24 weeks/168 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks/84 days and 24 weeks/168 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement in Diabetic Retinopathy Severity Scale (DRSS) score

Secondary study objectives

Proportion of patients with an improvement or worsening in DRSS

Safety and tolerability

Trial Design

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

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Diabetic Retinopathy (DR) include anti-VEGF (vascular endothelial growth factor) therapy, corticosteroids, and emerging treatments targeting metabolic pathways. Anti-VEGF therapy works by inhibiting the growth of abnormal blood vessels and reducing vascular permeability, which helps prevent vision loss. Corticosteroids reduce inflammation and edema in the retina. Emerging treatments, such as those being studied in the OPL-0401 trial, aim to address vascular damage and metabolic dysfunctions that contribute to DR. These treatments are crucial for DR patients as they target the root causes of the disease, potentially offering more effective and long-lasting protection against vision impairment.