Last updated: March 12, 2024
Sponsor: The Lowy Medical Research Institute Limited
Overall Status: Active - Not Recruiting
Phase
2
Condition
N/ATreatment
Fenofibrate
Serine
Clinical Study ID
NCT04907084
2020-002
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Signed and dated written informed consent obtained from the participant in accordancewith the local regulations;
- Males/females 21 years of age or older;
- English speaking;
- Enrolled in the Natural History Observation and Registry Study (NHOR) and diagnosedwith confirmed MacTel type 2 in at least one eye;
- Willing to use contraception, if applicable; and
- Willing to comply with study protocol and follow-up visits.
Exclusion
Exclusion Criteria:
- Participant is unable to provide informed consent;
- Participant is less than 21 years of age;
- Participant is currently taking, or has taken within four weeks prior to screening, aserine or glycine supplement;
- Participant is currently taking, or has taken within 12 months prior to screening,fibrates including clofibrate, ciprofibrate, bezafibrate, fenofibrate, andgemfibrozil;
- Participant is currently taking an anticoagulant, colchicine, cyclosporine, tacrolimusor bile acid binding resins;
- Participant has known allergy to fibrates and/or serine;
- Participant has a known history of clinically significant myopathy or myalgia relatedto cholesterol-lowering drugs;
- Participant has active liver disease and/or elevated liver enzymes*;
- Participant has renal dysfunction as evidenced by elevated serum creatinine* and/ orglomerular filtration rate (GFR) less than 90 mL/min;
- Participant has thrombocytopenia as evidenced by a platelet count below 100,000 permicroliter, anemia as evidenced by hemoglobin levels below 10 g/dL, or history ofbleeding disorder;
- Participant has a history of gallbladder disease or has had a cholecystectomy;
- Participant has triglyceride levels greater than 400 mg/dL on treatment, or greaterthan 700 mg/dL on no treatment;
- Participant has untreated/uncured Hepatitis C, or a history of Hepatitis B, autoimmunehepatitis, or HIV;
- Participant has had any malignancies within the last 5 years (not including basal cellcarcinoma);
- Participant has ever been enrolled in a clinical trial involving ciliary neurotrophicfactor (CNTF) treatment;
- Participant is currently enrolled in another clinical trial that involves treatment orparticipated in one within the last 30 days;
- Participant is pregnant, breastfeeding or planning a pregnancy;
- Participant is medically unable to comply with study procedures or follow-up visits;
- Participant has, in the opinion of the Investigator, any physical or mental conditionthat would increase the patient's risk of participation in the study or may interferewith the study procedures, evaluations and outcome assessments; or
- Patient is unavailable for follow-up visits. *based on reference range for the locallaboratory used
Study Design
Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Fenofibrate
Phase: 2
Study Start date:
April 07, 2022
Estimated Completion Date:
March 31, 2024
Study Description
Connect with a study center
Moorfields Eye Hospital
London, ECV2PD
United KingdomSite Not Available
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan 48105
United StatesSite Not Available
Retina Associates of Cleveland
Cleveland, Ohio 44122
United StatesSite Not Available
Southeastern Retina Associates
Knoxville, Tennessee 37922
United StatesSite Not Available
Retina Consultants of Texas
Bellaire, Texas 77401
United StatesSite Not Available
Moran Eye Center, University of Utah
Salt Lake City, Utah 84132
United StatesSite Not Available
University of Washington
Seattle, Washington 98104
United StatesSite Not Available
The Eye Institute, Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.