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DREAM


Title OTT166-201 A Phase 2 Randomized, Double-Masked, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of OTT166 Ophthalmic Solution in the Treatment of Diabetic Retinopathy (DR)
Therapeutic Area Eye Diseases, Retinal Disorders
Principal Investigator Michelle Liang, MD
Min Age 18 Years
Gender Any
Contact Karaghan Curran / Nancy Gee
617-636-1051 / 617-636-5489
neecresearch@tuftsmedicalcenter.com
More Information https://www.clinicaltrials.gov/ct2/show/NCT05409235

Overview

1. Men or women ≥18+ years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe Non-proliferative Diabetic Retinopathy 2. Treatment-naïve (ie, no previous anti-VEGF or steroid treatment or PRP or laser within 1,000 μm of the foveal center/treatment for macular edema or DR in the study eye) 3. Willing and able to return for all study visits and comply with study-related procedures

Study Details

Inclusion Criteria

1. Men or women ≥18+ years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe Non-proliferative Diabetic Retinopathy 2. Treatment-naïve (ie, no previous anti-VEGF or steroid treatment or PRP or laser within 1,000 μm of the foveal center/treatment for macular edema or DR in the study eye) 3. Willing and able to return for all study visits and comply with study-related procedures

Exclusion Criteria

1. Screening HbA1c blood test > 10.0% 2. Hypertension defined as systolic > 180 mmHg or > 160 mmHg on 2 consecutive measurements (during the same visit) or diastolic > 100 mmHg 3. Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months

Study Requirements

We anticipate you will be in this study for approximately 27 weeks. You will be asked to come into the eye center clinic every 4 weeks for a total of 8 visits. A routine eye exam will be performed by your study doctor at each visit, as well as pictures of your eyes that help your study doctor evaluate the health of the back of your eye. You will be asked to have blood drawn a total of 2 times during your study participation. You will be asked to self-administer the study eye drops for 24 weeks.