Phase IV Multicenter, Prospective, Open-Label Clinical Trial of Cenegermin (rhNGF) for Stage 1 Neurotrophic Keratopathy (DEFENDO)

Phase IV Multicenter, Prospective, Open-Label Clinical Trial of Cenegermin (rhNGF) for Stage 1 Neurotrophic Keratopathy (DEFENDO)

Introduction Cenegermin is approved for treatment of neurotrophic keratopathy (NK) and has been studied in patients with stage 2 or 3 NK. This study evaluated the efficacy and safety of cenegermin in adults with stage 1 NK. Methods This was a phase IV, multicenter, prospective, open-label, uncontrol...

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Veröffentlicht in:Ophthalmology and therapy 2024-02, Vol.13 (2), p.553-570
Hauptverfasser: Hamrah, Pedram, Massaro-Giordano, Mina, Schanzlin, David, Holland, Edward, Berdy, Gregg, Goisis, Giovanni, Pasedis, Georgea, Mantelli, Flavio
Format: Artikel
Sprache:eng
Schlagworte:
Cenegermin
Corneal epithelial defect
Internal Medicine
Medicine
Medicine & Public Health
NCT
NCT04485546
Neurotrophic keratitis
Neurotrophic keratopathy
Ophthalmology
Original Research
Recombinant human nerve growth factor
rhNGF
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Zusammenfassung:Introduction Cenegermin is approved for treatment of neurotrophic keratopathy (NK) and has been studied in patients with stage 2 or 3 NK. This study evaluated the efficacy and safety of cenegermin in adults with stage 1 NK. Methods This was a phase IV, multicenter, prospective, open-label, uncontrolled trial. Adults with stage 1 NK (Mackie criteria) and decreased corneal sensitivity (≤ 4 cm) received 1 drop of cenegermin 20 mcg/ml in the affected eye(s) 6 times/day for 8 weeks with a 24-week follow-up. Results Of 37 patients, corneal epithelial healing was observed in 84.8% (95% confidence interval [CI] 68.1–94.9%; P  
ISSN:2193-8245
2193-6528
DOI:10.1007/s40123-023-00866-y