NCT00331253

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

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.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 280 (planned)
• Sponsor: Opto Eletronica S.A. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To establish the safety and efficacy of indocyanine green-mediated photothrombosis (i-MP) for the treatment of patients with neovascular age-related macular degeneration.

Detailed description

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.

Conditions

• Maculopathy, Age-Related

Interventions

Type	Name	Description
PROCEDURE	Indocyanine Green-Mediated Photothrombosis

Timeline

• Start date: 2007-04-01
• Completion: 2008-12-01
• First posted: 2006-05-29
• Last updated: 2007-04-27

Locations

1 site across 1 country: Brazil