A PHASE 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangeictasia Type 2 (MacTel)
Sponsor:Neurotech USA, Inc
Principal Investigator: Barbara Blodi, MD
Study coordinator: Kris Dietzman
To investigate the effect of NT-501 on change from baseline in the ellipsoid zone (area of IS/OS loss) as measured by en face imaging by SDOCT in eyes with evidence of MacTel Type 2 at 24 months.
Prospective, multi-center, single-masked sham-controlled study. All participants will have a screening period of up to 14 days. Surgery/sham procedure will occur within 7 weeks after completing screening. Both eyes of the participants may be included in the study if eligible.
Participants with one study eye that meets the inclusion criteria will be randomized (1:1) to receive the NT-501 implant or sham procedure in the study-eligible eye. If both eyes are eligible, then the right eye will be randomized (1:1) to receive the NT-501 implant or sham procedure.
The left eye will receive the alternative surgery/sham. Study eyes will receive the NT-501 implant or sham procedure on Day 0 and will be assessed on Day 1, Week 1 (± 2 days), Month 1 (± 1 week), Month 3 (± 1 week), Month 6 (± 2 weeks), Month 12 (± 2 weeks), Month 18 (± 2 weeks) and Month 24 (± 2 weeks).
68 participants with MacTel Type 2
Diagnosis and Key Eligibility Criteria:
Ages 21 to 80 years, who at the time of the screening visit have at least one study eye with a positive diagnosis of MacTel Type 2 with evidence of fluorescein leakage typical of MacTel or at least one of the other features including retinal opacification, crystalline deposits, right angle vessels, inner/outer lamellar cavities or hyperpigmentation not involving the center of the fovea, but no evidence of intraretinal/subretinal neovascularization.
Participants must also have the presence of an IS/OS PR break in the study eye(s) and en face ellipsoid zone as measured by SDOCT between 0.16 mm2 and 4.00 mm2.
Duration of Treatment:
24 months primary endpoint, 24 months of total follow-up, 12 months interim analyses
For more information contact Kris Dietzman at 263-9035