1. Topical Recombinant Human Nerve Growth Factor (Cenegermin) for Neurotrophic Keratopathy A Multicenter Randomized Vehicle-Controlled Pivotal Trial
- Author
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Pflugfelder, Stephen C, Massaro-Giordano, Mina, Perez, Victor L, Hamrah, Pedram, Deng, Sophie X, Espandar, Ladan, Foster, C Stephen, Affeldt, John, Seedor, John A, Afshari, Natalie A, Chao, Wendy, Allegretti, Marcello, Mantelli, Flavio, and Dana, Reza
- Subjects
Biomedical and Clinical Sciences ,Ophthalmology and Optometry ,Clinical Trials and Supportive Activities ,Physical Injury - Accidents and Adverse Effects ,Eye Disease and Disorders of Vision ,Neurosciences ,Clinical Research ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Eye ,Administration ,Ophthalmic ,Adult ,Aged ,Aged ,80 and over ,Cornea ,Corneal Ulcer ,Double-Blind Method ,Epithelium ,Corneal ,Female ,Fluorophotometry ,Follow-Up Studies ,Humans ,Male ,Middle Aged ,Nerve Growth Factor ,Ophthalmic Solutions ,Recombinant Proteins ,Treatment Outcome ,Trigeminal Nerve Diseases ,Visual Acuity ,Wound Healing ,Clinical Sciences ,Opthalmology and Optometry ,Public Health and Health Services ,Ophthalmology & Optometry ,Ophthalmology and optometry - Abstract
PURPOSE:To evaluate the efficacy and safety of topical cenegermin (recombinant human nerve growth factor) in patients with neurotrophic keratopathy. DESIGN:Multicenter, randomized, double-masked, vehicle-controlled trial. PARTICIPANTS:Patients with neurotrophic persistent epithelial defect with or without stromal thinning. METHODS:The NGF0214 trial, conducted among 11 sites in the United States, randomized 48 patients 1:1 to cenegermin 20 μg/ml or vehicle eye drops, 6 drops daily for 8 weeks of masked treatment. Follow-up was 24 weeks. Safety was assessed in all patients who received study drug. Efficacy was assessed by intention to treat. MAIN OUTCOME MEASURES:The primary end point was healing of the neurotrophic lesion (persistent epithelial defect or corneal ulcer) after 8 weeks of masked treatment. Masked central readers measured neurotrophic lesions in randomized clinical pictures, then assessed healing status conventionally (
- Published
- 2020