Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis.

Phase 1/2 Completed 174 enrolled Dompé Farmaceutici S.p.A

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is aimed at assessing the safety and the efficacy of two dose regimens of recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle for inducing a complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer) neurotrophic keratitis

Timeline

Start: 2013-01
Primary completion: 2015-04
Completion: 2016-05

Outcome

Met primary endpoint

registry analysis (superiority test); 4_rhNGF10_Phase 2_treatment vs 6_vehicle group_Phase 2_treatment; p <0.001; Difference in percentage 35.3 (97.06% CI 15.88 to 54.71); Chi-squared NCT01756456 ↗

registry analysis (superiority test); 5_rhNGF20_Phase 2_treatment vs 6_vehicle group_Phase 2_treatment; p =0.001; Difference in percentage 38.4 (97.06% CI 18.96 to 57.83); Chi-squared NCT01756456 ↗

Publications

Yanai R, Nishida T, Chikama T, Morishige N, Yamada N, Sonoda KH. Potential New Modes of Treatment of Neurotrophic Keratopathy. Cornea. 2015 Nov;34 Suppl 11:S121-7. doi: 10.1097/ICO.0000000000000587.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	rhNGF	Protein / enzyme biologic	10 ug/ml	Other
Subject	rhNGF	Protein / enzyme biologic	20 ug/ml	Other