A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel

Completed · Phase 2 · Has a placebo group

Conditions studied: Macular Telangiectasia Type 2

In brief

This study is a phase 2, randomized, multi-center, single-masked study to evaluate the efficacy and safety of the NT-501 implants in participants with Mactel.

Key facts

Study ID

NCT01949324

Run by

Neurotech Pharmaceuticals

People needed

67

Starts

2014-04-01

Expected to finish

2017-05-22

Last updated by the study team

2018-09-12

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form's contents and sign the protocol's informed consent
• Participant must have at least one study eye with a positive diagnosis of MacTel Type 2
• Participant must have an IS/OS PR break in the study eye(s) and en face ellipsoid zone (area of IS/OS loss) as measured by SDOCT between 0.16 mm2 and 4.00 mm2
• If female, participant must be incapable of pregnancy
• If male, participant must agree to use an effective form of birth control during the study

You may not qualify if…

• Participant is unable to provide informed consent
• Participant is less than 21 years of age or greater than 80 years of age
• Participant is medically unable to comply with study procedures or follow-up visits
• Participant was a study subject in any other clinical trial of an intervention (drug or device) within the last 6 months
• Participant is pregnant or breastfeeding

Where it is running

• Jules Stein Eye Institute — Los Angeles, California, United States
• Bascom Palmer — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• National Eye Institute — Bethesda, Maryland, United States
• Massachusetts Eye and Ear Infirmary, Retina Service — Boston, Massachusetts, United States
• University of Michigan, Kellogg Eye Center — Ann Arbor, Michigan, United States
• Retina Associates of Cleveland, Inc. — Beachwood, Ohio, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Save Sight Institute — Sydney, New South Wales, Australia
• Centre for Eye Research Australia — East Melbourne, Australia
• Lions Eye Institute — Nedlands, Australia

Full record on ClinicalTrials.gov

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