Maculopathy, Age-Related Clinical Trial
Official title:
A 54-WEEK, PHASE 2, MULTICENTER, MASKED, RANDOMIZED, CONTROLLED TRIAL TO ESTABLISH THE SAFETY AND EFFICACY OF INDOCYANINE GREEN-MEDIATED PHOTOTHROMBOSIS (i-MP) FOR THE TREATMENT OF PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION.
To establish the safety and efficacy of indocyanine green-mediated photothrombosis (i-MP) for the treatment of patients with neovascular age-related macular degeneration.
Comparative, controlled, multicenter, masked, randomized study, three parallel groups,
comparing the Indocyanine Green-Mediated Photothrombosis to two control groups, for the
treatment of neovascular Age-Related Macular Degeneration.
Only patients matching the following criteria are eligible:
A. BCVA worse than 20/80 and neovascular complex with some component of occult CNV as
defined by the fluorescein angiography, or; B. BCVA worse than 20/80 and neovascular complex
with total area of CNV (classic and occult) by fluorescein angiography occupying an area
lesser than 50% of the neovascular complex, or; C. BCVA worse than 20/200 and neovascular
complex with some CNV (classic OR occult) by fluorescein angiography.
The eligibility of the patients will be assessed by an independent Centre of Interpretation
after masked analysis.
Eligible patients will be allocated into one of the three study groups, randomized at 2:1:1
proportion:
Group 1: Treatment Procedure #1 = i-MP (ICG + Laser), at proportion of 2. In this group the
patients will be submitted to endovenous infusion of ICG followed by irradiation with diode
laser.
Group 2: Treatment Procedure #2 (Distilled water + Laser), at proportion of 1. In this group
the patients will receive endovenous placebo infusion (distilled water) followed by
irradiation with diode laser with same power utilized in Group 1.
Group 3: Treatment Procedure #3 (Distilled water + Sham Laser), at proportion of 1. In this
group the patients will receive endovenous placebo infusion (distilled water) followed by
simulated application of laser.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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