A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel (NCT01949324) | Clinical Trial Compass
CompletedPhase 2
A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel
United States67 participantsStarted 2014-04
Plain-language summary
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.
Who can participate
Age range21 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
Ellipsoid zone (area of IS/OS loss) as measured by en face imagining by SDOCT in study eye(s)