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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
Summary
This trial is testing OTT166 eye drops to see if they can help people with diabetic retinopathy who haven't had other treatments. The drops aim to protect the retina by preventing harmful changes in blood vessels caused by diabetes.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of Participants Who Improved by ≥ 2 Steps From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Scores
Secondary study objectives
Area Under The Curve (AUC) for Change From Baseline in CST
Area Under the Curve for BCVA (ETDRS Letters) From Baseline to Week 24
Change From Baseline in Best Corrected Visual Acuity (BCVA)
+14 moreOther study objectives
Proportion of Participants That Develop a VTC by Week 24 for DRSS Levels 47 and 53 at Baseline
Proportion of Participants Who Developed CI-DME at Week 24 for Randomization Strata DRSS 47 and 53
Side effects data
From 2023 Phase 2 trial • 225 Patients • NCT054092358%
Punctate keratitis
8%
Retinal neovascularisation
8%
Diabetic retinopathy
5%
Diabetic retinal oedema
5%
Macular oedema
3%
Dehydration
3%
Cerebrovascular accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle Control Cohort 1
Vehicle Control Cohort 2
OTT166 Cohort 1
OTT166 Cohort 2
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: OTT166 Cohort 2Experimental Treatment1 Intervention
Participants will receive OTT166 5% four times a day (QID) for 24 weeks
Group II: OTT166 Cohort 1Experimental Treatment1 Intervention
Participants will receive OTT166 5% twice a day (BID) for 24 weeks
Group III: Vehicle control Cohort 1Placebo Group1 Intervention
Participants will receive vehicle control BID for 24 weeks
Group IV: Vehicle control Cohort 2Placebo Group1 Intervention
Participants will receive vehicle control QID for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OTT166
2022
Completed Phase 2
~230
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
Common treatments for Diabetic Retinopathy (DR) include anti-VEGF (vascular endothelial growth factor) injections, corticosteroids, and laser therapy. Anti-VEGF treatments, such as ranibizumab and aflibercept, work by inhibiting the growth of abnormal blood vessels and reducing vascular permeability, which helps to prevent vision loss.
Corticosteroids reduce retinal inflammation and edema, thereby improving visual acuity. Laser therapy seals leaking blood vessels and reduces the risk of further hemorrhage.
These treatments are crucial for DR patients as they address the underlying pathophysiological processes of inflammation and abnormal blood vessel growth, which are key contributors to vision impairment in DR.
Find a Location
Who is running the clinical trial?
ParexelIndustry Sponsor
313 Previous Clinical Trials
96,459 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: Vehicle control Cohort 1
- Group 2: OTT166 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