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

NCT02110225 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-04-18

Study results available
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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.

Conditions

Interventions

DRUG

rhNGF 60 µg/ml eye drops solution

rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes

DRUG

rhNGF 180 µg/ml eye drops solution

rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes

DRUG

Placebo

Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Flavio Mantelli, MD, PhD · Dompé farmaceutici S.p.A., Milan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02110225 on ClinicalTrials.gov