Clinical trials

Active, recruitment completed

An 8-week phase I/II, multicenter, randomized, double-masked, vehicle controlled parallel group study with a 48 or 56 week follow-up period to evaluate the safety and efficacy of two doses (10 µg/ml and 20 µg/ml) of recombinant human nerve growth factor eye drops solution versus vehicle in patients with Stage 2 and 3 of Neurotrophic Keratitis

REPARO - NGF0212

An 8-week phase I/II, multicenter, randomized, double-masked, vehicle controlled parallel group study with a 48 or 56 week follow-up period to evaluate the safety and efficacy of two doses (10 µg/ml and 20 µg/ml) of recombinant human nerve growth factor eye drops solution versus vehicle in patients with Stage 2 and 3 of Neurotrophic Keratitis

What is the purpose of this study?

To assess the safety and the efficacy of two dose regimens (10 µg/ml or 20 µg/ml 6 times a day) of recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle for inducing a complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer) neurotrophic keratitis (NK) as measured by the central reading center evaluating the clinical pictures of corneal fluorescein staining.

Trial overview

Condition

Unilateral stage 2 (persistent epithelial defect) and stage 3 (corneal ulcer) NK refractory to one or more conventional non-surgical treatments

Study Identifiers

NCT01756456

Study type

Interventional
Randomized
Vehicle controlled

Intervention

Drug: rhNGF 10 µg/ml eye drops solution
Drug: rhNGF 20 µg/ml eye drops solution
Drug: Placebo Vehicle eye drops solution

Phase

I/II

Start date

Jan 2013

End Date

May2016

Enrollment Goal

174

Going deep into the trial

Eligibility/Recruitment

Age

≥18 years old

Gender

Accepts healthy volunteers

Key Criteria

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Inclusion

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Exclusion

Some information about patients involvement

Study participation will last a maximum of approximately 64 weeks and will include up to 26 visits to the study center

Desired Outcomes

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Primary Outcomes

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Secondary Outcomes

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