This study aims at investigating the therapeutic potential of recombinant human Nerve Growth Factor ( rhNGF ) eye drops treatment in patients with Retinitis Pigmentosa (RP) associated with cystoid macular edema (CME) in a phase II, randomized, double-masked, controlled clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
eye drops
placebo
Ospedale San Raffaele
Milan, Italy
Ospedale Sacco
Milan, Italy
macular thickness
assessed by ocular coherence tomography (OCT)
Time frame: 28 days of treatment
visual field
mean deviation
Time frame: 28 days of treatment, 1 month, 6 months and 12 months of follow-up
macular photoreceptors thickness
assessed by OCT
Time frame: 28 days of treatment, 1 month,3 months, 6 months and 12 months of follow-up
macular thickness
assessed by OCT
Time frame: 1 month,3 months, 6 months and 12 months of follow-up
electroretinogram (ERG)
amplitudes
Time frame: 28 days of treatment, 1 month, 6 months and 12 months of follow-up
visual acuity
Time frame: 28 days of treatment,1 month,3 months, 6 months and 12 months of follow-up
contrast sensitivity
Time frame: 28 days of treatment, 1 month,3 months, 6 months and 12 months of follow-up
quality of life
Time frame: 28 days of treatment, 1 month,3 months, 6 months and 12 months of follow-up
number of cystoid macular edema relapses
Time frame: through study completion, up to 12 months of follow-up
number of drop out for inefficacy of the study treatment
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Time frame: through study completion, up to 12 months of follow-up
adverse events
Time frame: through study completion, up to 12 months of follow-up