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OTT166 for Diabetic Retinopathy
Phase 2
Waitlist Available
Led By Carl Regillo, MD
Research Sponsored by OcuTerra Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (day 1) up to week 24
Awards & highlights
Study Summary
This trial will study a new eye solution to see if it is safe and effective in treating diabetic retinopathy.
Who is the study for?
Adults over 18 with type 1 or type 2 diabetes and moderate to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR), who have good vision (20/40 or better) and haven't had previous treatments like anti-VEGF, steroids, laser therapy, or surgery for their eye condition. Participants must not be using certain diabetes medications unless on a stable dose for at least a year.Check my eligibility
What is being tested?
The trial is testing OTT166 Ophthalmic solution against a vehicle control to see if it's safe and effective in treating Diabetic Retinopathy. Patients will receive either the study drug or a placebo in their eyes to compare outcomes.See study design
What are the potential side effects?
While specific side effects of OTT166 are not listed here, common side effects from ophthalmic solutions can include eye irritation, redness, discomfort, blurred vision temporarily after application, potential allergic reactions, and rarely more serious eye conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (day 1) up to week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day 1) up to week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants who have improved by ≥ 2 steps from baseline in Diabetic Retinopathy Severity Scale (DRSS) scores
Proportion of participants with treatment-emergent adverse events (TEAEs)
Secondary outcome measures
AUC for change from baseline in CST
Area under the curve (AUC) for change from baseline in BCVA
Change from baseline in best corrected visual acuity (BCVA)
+14 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: OTT166 Cohort 2Experimental Treatment1 Intervention
Participants will receive OTT166 high dose for 24 weeks
Group II: OTT166 Cohort 1Experimental Treatment1 Intervention
Participants will receive OTT166 low dose for 24 weeks
Group III: Vehicle control Cohort 1Placebo Group1 Intervention
Participants will receive vehicle control for 24 weeks
Group IV: Vehicle control Cohort 2Placebo Group1 Intervention
Participants will receive vehicle control for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OTT166
2022
Completed Phase 2
~230
Find a Location
Who is running the clinical trial?
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,601 Total Patients Enrolled
OcuTerra Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
88 Total Patients Enrolled
Carl Regillo, MDPrincipal InvestigatorPrincipal Investigator
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have chronic or repeat inflammation in the eye being studied.You were born with an eye problem in the eye being studied.You currently have an eye infection or inflammation in either eye.You have not received any previous treatments with certain types of medications or laser therapy.You have eye conditions that could affect your vision in the eye being studied.Your eye doesn't allow clear pictures to be taken for the study.You have received treatment for a specific type of eye condition with medication that targets VEGF.You cannot have used certain diabetes medications in the past year, and you cannot plan to start using them during the study.You have had a cataract surgery that had complications in the eye being studied.Adults with type 1 or 2 diabetes who have a certain level of eye disease related to diabetes.Your central subfield thickness (CST) is over 325 micrometers. If there is fluid in the middle of your eye, it's okay as long as your CST is 325 micrometers or less and your eye's center looks normal, as checked by a special eye center.You have not had certain types of laser treatment in the eye being studied.If your eyes have a certain score and show signs of fibrous growth, you won't be able to participate.Your HbA1c blood test result is higher than 12.0%.You have severe kidney problems or need dialysis or have had a kidney transplant.You had laser treatment in your study eye within the last 90 days before joining the study.You have a serious eye condition that affects the center of your vision.You have had a serious injury to your eye from something sharp.You have certain eye conditions in the study eye that the doctor thinks are important.You have had a specific eye surgery called pars plana vitrectomy in the eye being studied.Your vision in the study eye is 20/40 or better.You currently have specific eye conditions in the eye being studied.You have uncontrolled high pressure in your eye, even with treatment.You have not received any previous treatment with specific medications or procedures for your condition.Your blood pressure is very high, with the top number (systolic) being over 180 or over 160 on two separate readings, or the bottom number (diastolic) being over 100.You have significant changes in your cornea from dry eye or Sjogren's syndrome.You have received a steroid injection in your eye, such as Iluvien® or Retisert®, before joining the study. However, using Ozurdex® or triamcinolone more than 12 months ago is allowed.Adults with type 1 or type 2 diabetes who have a specific level of eye damage and can wait at least 6 months before starting certain eye treatments.Your fovea (a part of the eye) has a regular shape.You started using intensive insulin treatment within the last 4 months or plan to start using it in the next 4 months.
Research Study Groups:
This trial has the following groups:- Group 1: OTT166 Cohort 1
- Group 2: Vehicle control Cohort 1
- Group 3: Vehicle control Cohort 2
- Group 4: OTT166 Cohort 2
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: NCT05409235 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What goals is this research endeavor attempting to reach?
"This clinical trial's primary outcome, to be assessed at the end of Week 24, is determining if there has been an improvement in Diabetic Retinopathy Severity Scale (DRSS) scores for patients by two or more levels. Secondary objectives include assessing whether topical OTT166 can avert/delay visually threatening complications such as PDR (with vitreous haemorrhage and tractional retinal detachment due to PDR), anterior segment neovascularization and center-involved diabetic macular edema; the effect on central subfield thickness via OCT scans; and ascertaining how long it takes before a patient experiences PDR"
Answered by AI
How many physical sites are being utilized to conduct this trial?
"At present, the trial has enlisted 52 patients from various medical centres such as Clinical Site 153 of Saint Petersburg, Clinical Site 146 in Oak Forest and Clinical Site 148 in Spokane."
Answered by AI
To what extent is OTT166 a hazard to human health?
"OTT166 has been allocated a score of 2 on our safety scale, as there is good evidence to suggest its security but no confirmation that it will be effective in practice."
Answered by AI
Is enrollment still available for those interested in participating in this clinical investigation?
"Affirmative, according to clinicaltrials.gov this experiment is currently recruiting patients – it was first posted on July 29th 2022 and the listing has been modified as of November 3rd 2022. The trial requires 210 test subjects from a total 52 sites across the country."
Answered by AI
How many participants are being accepted for this experiment?
"To properly conduct this clinical study, 210 eligible individuals must be identified and enrolled. Patients can join at Clinical Site 153 located in Saint Petersburg, Florida or Clinical Site 146 found in Oak Forest, Illinois."
Answered by AI
Who else is applying?
What state do they live in?
Oklahoma
New Jersey
Louisiana
Other
What site did they apply to?
Clinical Site 128
Clinical Site 136
Clinical Site 114
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
1
0
Why did patients apply to this trial?
I want to cure my retinopathy. I am having trouble with my eyes. I have been to multiple doctors here in Louisiana with no help, i am determined to see again!
PatientReceived no prior treatments
I have tried 3 other medications, and nothing seems to work. I am very interested in a clinical study.
PatientReceived 1 prior treatment
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