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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional




Official Title: A 24 Week Phase Ib/II, Multicenter, Randomized, Double-masked, Vehicle Controlled, Parallel Group, Dose Ranging Study With a 24 Week Follow-up Period to Evaluate the Safety and Potential Efficacy of T

Brief 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.