drugset / Trial / NCT02110225

A Dose Ranging Study to Evaluate the Safety and Potential Efficacy of rhNGF in Patients With Retinitis Pigmentosa (RP)

NCT02110225 ↗

Phase 1/2 Completed 50 enrolled Dompé Farmaceutici S.p.A
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to assess the safety and tolerability of two dose regimens of recombinant human nerve growth factor (rhNGF) eye drops solution administered over 6 months versus a vehicle control in patients with typical retinitis pigmentosa. The secondary objective of this study is to attempt to show a dose response by assessing the potential efficacy of the rhNGF dose regimens for improving or slowing the deterioration of visual function outcomes at 3 and 6 months. During a 6 month follow-up period patients will be monitored to determine if there is evidence of a persistent biological effect after discontinuation of the study treatment.

Timeline

Start
2014-01
Primary completion
2015-11
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject rhNGF Protein / enzyme biologic 60 ug/ml Topical
Subject rhNGF Protein / enzyme biologic 180 ug/ml Topical

Indications