At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 24 Week Phase Ib/II, Multicenter, Randomized, Controlled, Parallel Group, Dose Ranging Study With a 24 Week Follow-up to Evaluate Safety and Potential Efficacy of 2 Doses (60, 180 µg/ml) of rhNGF Solution vs Vehicle in Patients With RP.
In Brief
A Phase 2 clinical trial evaluating rhNGF 60 µg/ml eye drops solution, rhNGF 180 µg/ml eye drops solution, and 1 other intervention for Retinitis Pigmentosa. Completed, enrolled 50 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes
rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes
Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes