Overview

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

Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Dompé Farmaceutici S.p.A
Treatments:
Mitogens
Ophthalmic Solutions
Pharmaceutical Solutions
Tetrahydrozoline