Treatment of Patients With Neovascular AMD Using Indocyanine Green-Mediated Photothrombosis (i-MP).
Recruitment status was Recruiting
To establish the safety and efficacy of indocyanine green-mediated photothrombosis (i-MP) for the treatment of patients with neovascular age-related macular degeneration.
Procedure: Indocyanine Green-Mediated Photothrombosis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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.|
- Compare the groups in respect to proportion of eyes that lost less than 15 letters in ETDRS BCVA from baseline at week-54
- Compare the groups in respect to proportion of eyes that did not present any loss in ETDRS BCVA (2 letters change) from baseline at week-54
- Compare the groups in respect to mean change in ETDRS BCVA
- Compare the groups in respect to neovascular complex activity (size and CNV leaking area)
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||December 2008|
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.
|Contact: Elizeu Ramos, M.S.||55 16 33737023||ELIZEU@opto.com.br|
|Contact: Rogério Costa, M.D.||55 16 email@example.com|
|Universidade Federal de Goias||Recruiting|
|Goiania, Goias/Go, Brazil, 00000|
|Contact: Avila Marcos, MD 55-16-3252 5566 firstname.lastname@example.org|
|Contact: David Isaac, MD 55-16-3252 5566 email@example.com|
|Principal Investigator: Avila Marcos, MD|
|Study Director:||Elizeu Ramos, M.S.||Opto Eletrônica S.A.|
|Principal Investigator:||Avila Marcos, MD||Universidade Federal de Goias|