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OPL-0401 for Diabetic Retinopathy (Spectra Trial)
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks/84 days and 24 weeks/168 days
Awards & highlights
Spectra Trial Summary
This trial is testing a new medication to see if it is effective and safe for patients with diabetes who also have diabetic retinopathy.
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.Check my eligibility
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.See study design
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.
Spectra Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My vision, with correction, is at least 20/40 or better without diabetic macular edema, or 20/32 with it.
Select...
I am not able to have children or I agree to use birth control.
Select...
I have severe diabetic retinopathy in at least one eye.
Select...
I have diabetes.
Select...
I have diabetes.
Spectra Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement in Diabetic Retinopathy Severity Scale (DRSS) score
Secondary outcome measures
Proportion of patients with an improvement or worsening in DRSS
Safety and tolerability
Spectra 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
Find a Location
Who is running the clinical trial?
Valo Health, Inc.Lead Sponsor
1 Previous Clinical Trials
Philip Yin, M.D., Ph.D.Study DirectorValo Health, Inc.
Victor Shi, M.D.Study DirectorValo Health, Inc.
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My vision, with correction, is at least 20/40 or better without diabetic macular edema, or 20/32 with it.I have had DME treated with an Iluvien injection before.My vision loss won't improve with standard diabetic eye disease treatments.I am not able to have children or I agree to use birth control.I have had surgery on the back part of my eye.My blood pressure is not controlled, even with medication.I have a severe form of diabetic eye disease, but not the mildest.I am 18 years old or older.I don't need nor expect to need eye treatments for blood vessel growth for 6 months.My eyes have abnormal blood vessel growth except for mild PDR.I have severe diabetic retinopathy in at least one eye.My diabetes is not under control or I am not being treated for it.I haven't had eye infections or inflammation in the last 3 months.I may have diabetic macular edema but still meet the study's requirements.I haven't had eye surgery in the past 3 months nor plan to during the study.I have diabetes.You have a very high body mass index, which means you are severely overweight.I have had laser treatment for diabetic eye disease.I have glaucoma that isn't controlled by medication.I may have diabetic macular edema but still meet the study's requirements.I have diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: OPL-0401 Dose 1
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Diabetic Retinopathy Patient Testimony for trial: Trial Name: NCT05393284 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment period for this experiment still open?
"Affirmative. According to the information accessed on clinicaltrials.gov, this research is actively recruiting participants and requires 120 individuals from 20 medical facilities. The endeavour was first posted in August 16th 2022 and its details were recently updated November 18th 2022."
Answered by AI
Are there many Canadian medical centers that are currently conducting this research?
"This clinical trial operates in 20 different locations, including The Retina Care Center of Baltimore, Massachussetts Eye and Ear from Boston, and Medical Center Ophthalmology Associates located in San Antonio."
Answered by AI
How many participants are contributing to the research?
"Valo Health, Inc., the financial sponsor of this research project, requires 120 participants that meet their trial inclusion criteria. The Retina Care Center in Baltimore and Massachussetts Eye and Ear in Boston will be two sites where data collection occurs."
Answered by AI
To what degree could OPL-0401 Dose 1 prove injurious for trial participants?
"OPL-0401 Dose 1 was rated a 2, indicating that while there is limited evidence of its safety, there is no data to suggest efficacy."
Answered by AI
Who else is applying?
What state do they live in?
Louisiana
New York
Illinois
What site did they apply to?
Eye Associates of Northeast Louisiana
Retina Associates of Michigan
Massachussetts Eye and Ear
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I want to cure my diabetic retinopathy.
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- Massachussetts Eye and Ear: < 48 hours
Typically responds via
Phone Call
Email
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