Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma
Status:
Completed
Trial end date:
2018-05-01
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to assess the safety and tolerability of a 180μg/ml TID
dose regimen of recombinant human nerve growth factor (rhNGF) eye drop solution administered
over 8 weeks versus a vehicle control in patients with progressive primary open-angle
glaucoma despite IOP control.
The secondary objectives are to measure the changes in BCDVA, visual field, ERG and
structural changes in ganglion cell layer and nerve fiber layer thickness measured by optical
coherence tomography. The secondary outcomes will be examined at 1, 4 and 8 weeks of therapy,
and at 4 and 24 weeks after cessation of therapy (Week 12 visit and Week 32 visit), and will
include functional assessments to investigate evidence of a persistent biological effect
after discontinuation of the study treatment.