This study is a phase 1, open label, non-randomized, multi-center, pilot study to evaluate the safety and tolerability of NT-501 implants in 5-7 study participants with Mactel.
Protocol for Extended Follow-up of a Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients with Macular Telangiectasia Type 2 (MacTel)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Ciliary neurotrophic factor (CNTF) implant
Jules Stein Eye Institute
Los Angeles, California, United States
Retina Associates of Cleveland
Cleveland, Ohio, United States
Visual Acuity
Visual acuity decrease of \>=15 letters
Time frame: 3,12, 24 and 36 months
Microperimetry
Change of a 10dB at least one point either adjacent to a pre-existing scotoma or in a new area within the central 10 degrees on microperimetric testing
Time frame: 12, 24 and 36 months
OCT
Change in en face area as measured by OCT
Time frame: 12, 24, and 36 months
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