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Safety Study to Evaluate Bilateral CNTF Implants in Subjects With MacTel Type 2

About

Brief Summary

This is a multi-center, open-label, 6-month study to evaluate the safety of bilateral CNTF implants in participants with Macular Telangiectasia Type 2.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
85 Years

Inclusion Criteria:

  • Must understand and sign the informed consent
  • Must be medically able to undergo ophthalmic surgery for the NT-501 device insertion and able to complete all required study procedures and visits
  • Participant must have received a NT-501 implant in one eye and have completed either the multicenter Phase 1 or Phase 2 study of NT-501 in subjects with MacTel
  • In the eye that does not have a NT-501 implant, participant must have a positive diagnosis of macular telangiectasia, type 2
  • Participant must have steady fixation in the foveal or parafoveal area and sufficiently clear media for good quality photographs

Exclusion Criteria:

  • Pregnant (positive pregnancy test at Visit 1 or intend to become pregnant during the study)
  • Nursing (lactating)
  • Participant has evidence of ocular disorder(s) in the study eye of a severity that could confound the interpretation of study results
  • Participant has a history or evidence of the following surgeries/procedures in the study eye, as assessed at Visit 1, including: Submacular surgery, Vitrectomy, Retinal detachment, Incisional glaucoma surgery, Trabeculectomy or trabeculoplasty, Cataract surgery or laser-assisted in situ keratomileusis (LASIK) performed in the previous 6 months

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Study Stats
Protocol No.
21-000779
Category
Ophthalmology
Principal Investigator
Jean Hubschman
Contact
Rosaleen Ostrick
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04729972
For detailed technical eligibility, visit ClinicalTrials.gov.