作者
Stefano Bonini, Alessandro Lambiase, Paolo Rama, Francesco Sinigaglia, Marcello Allegretti, Wendy Chao, Flavio Mantelli, Elisabeth Messmer, Pasquale Aragona, Gerd Geerling, Leonardo Mastropasqua, Rita Mencucci, John Dart, Andrea Leonardi, Jesus Montero, Maurizio Rolando, Thomas Reinhard, Claus Cursiefen, Jaime Etxebarria, Eric Gabison, Jacek P Szaflik, Nacim Bouheraoua, Maria De La Paz, Maite Sainz de la Maza, Edward Wylegala, Francisco Figueiredo, Paolo Fogagnolo, Parwez Hossain, Katrin Lorenz, Pierre-Yves Robert, José Benitez del Castillo, Catherine Creuzot-Garcher, Friedrich Kruse, François Malecaze, Jesús Merayo-Lloves, Saaeha Rauz, Jorge Alio, Fiona Carley, Ramaesh Kanna, Carina Koppen, Janos Nemeth, Joaquim Neto Murta, Luis Torrao
发表日期
2018/9/1
期刊
Ophthalmology
卷号
125
期号
9
页码范围
1332-1343
出版商
Elsevier
简介
Purpose
To evaluate the safety and efficacy of topical recombinant human nerve growth factor (rhNGF) for treating moderate-to-severe neurotrophic keratitis (NK), a rare degenerative corneal disease resulting from impaired corneal innervation.
Design
Phase II multicenter, randomized, double-masked, vehicle-controlled trial.
Participants
Patients with stage 2 (moderate) or stage 3 (severe) NK in 1 eye.
Methods
The REPARO phase II study assessed safety and efficacy in 156 patients randomized 1:1:1 to rhNGF 10 μg/ml, 20 μg/ml, or vehicle. Treatment was administered 6 drops per day for 8 weeks. Patients then entered a 48- or 56-week follow-up period. Safety was assessed in all patients who received study treatment, whereas efficacy was by intention to treat.
Main Outcome Measures
Corneal healing (defined as <0.5-mm maximum diameter of fluorescein staining in the lesion area) was assessed by masked central …
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