Trials / NCT02110225
A Dose Ranging Study to Evaluate the Safety and Potential Efficacy of rhNGF in Patients With Retinitis Pigmentosa (RP)
Completed Phase 1 / Phase 2 Drug / neuroprotection
- Sponsor
- Dompé Farmaceutici S.p.A
- Treatment
- rhNGF 60 µg/ml eye drops solution; rhNGF 180 µg/ml eye drops solution; Placebo
- Gene
- Not stated
- Conditions
- Retinitis Pigmentosa
- Ages
- 18 Years to no upper limit
- Enrollment
- 50 participants
- Started
- 2014-01
- Main results expected
- 2015-11
- Results posted
- Yes
- Record last updated
- 2024-04-18
What the study is testing
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.
Where it runs
Italy (5)
- Azienda Ospedaliero Universitaria Careggi, Florence
- Azienda Ospedaliera San Paolo - U.O. Oculistica, Milan
- A.O. Seconda Università Degli Studi di Napoli - Nuovo Policlinico - UOC Oftalmologia, Naples
- Università Cattolica del Sacro Cuore - Policlinico Gemelli - Istituto di Oftalmologia, Rome
- IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia, Rome