Treatment of Patients With Neovascular AMD Using Indocyanine Green-Mediated Photothrombosis (i-MP).

  • participants needed
  • sponsor
    Opto Eletronica S.A.
Updated on 7 November 2020
indocyanine green
wet age-related macular degeneration
fluorescein angiography
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.

Condition age-related macular degeneration
Treatment Indocyanine Green-Mediated Photothrombosis
Clinical Study IdentifierNCT00331253
SponsorOpto Eletronica S.A.
Last Modified on7 November 2020


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