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Phase I NT-501 Ciliary Neurotrophic Factor Implant Trial for Primary Open-Angle Glaucoma by Jeffrey L. Goldberg; Gala Beykin; Kellie R. Satterfield; Mariana Nuñez; Byron L. Lam; Thomas A. Albini is a Medicine article available to read on EtoBox.

What is Phase I NT-501 Ciliary Neurotrophic Factor Implant Trial for Primary Open-Angle Glaucoma about?

## 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 events (AEs) recording. Parameters measured included visual acuity (VA), Humphrey visual field (HVF), pattern electroretinogram, scanning laser polarimetry with variable corneal compensation (GDx VCC), and OCT. These parameters were also used for secondary analysis of efficacy outcome. ## Results All NT-501 implants were well tolerated with no serious AEs associated with the implant. The majority of AEs were related to

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Author

Jeffrey L. Goldberg; Gala Beykin; Kellie R. Satterfield; Mariana Nuñez; Byron L. Lam; Thomas A. Albini

Publisher

Elsevier BV

Published

2023

Language

EN

Field

Medicine (Health Sciences)