Phase I NT-501 Ciliary Neurotrophic Factor Implant Trial for Primary Open-Angle Glaucoma: Safety, Neuroprotection, and Neuroenhancement.

ABSTRACT:

Purpose

To assess the safety and efficacy of a ciliary neurotrophic factor (CNTF) intraocular implant on neuroprotection and neuroenhancement in glaucoma.

Design

Open-label, prospective, phase I clinical trial.

Participants

A total of 11 participants were diagnosed with primary open-angle glaucoma (POAG). One eye of each patient was assigned as the study (implant) eye.

Methods

The study eye was implanted with a high-dose CNTF-secreting NT-501 implant, whereas the other eye served as a control. All patients were followed up for 18 months. Analysis was limited to descriptive statistics.

Main outcome measures

Primary outcome was safety through 18 months after implantation assessed by serial eye examinations, structural and functional testing, and adverse ev

SUBMITTER: Goldberg JL 

PROVIDER: S-EPMC10183667 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature