The i-MP procedure is in phase II of a multicenter clinical trial to establish the safety and efficacy of the treatment of patients bearing exudative AMD. The study involves 280 patients at 17 medical centres in Brazil.

Official Title
A 54-Week, Phase 2, Multicenter, Masked, Randomised, 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.

Accreditation
Approval was given by the National Health Surveillance Agency (ANVISA) and the National Committee for Ethics in Research (CONEP) of Brazil for trialling 280 patients.

Study start: April 2007

Expected completion: December 2008

Chief Investigator: Dr. Marcos Avila, Head Professor and Chairman of the Ophthalmology Department at Universidade Federal de Goias, and Chief of the Vitreo Retinal Department, Centro Brasileiro de Cirurgia de Olhos, Goiania, Brazil.
 

Phase II Study Details

  

Eligibility

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.

Inclusion criteria:

  • Age over 50 years;
  • Presence of at least of soft Drusen in macular region, associated or not with pigment alterations (hyper or hypo-pigmentation), thus characterizing AMD;
  • Vision reduction arising exclusively from exudative macular processes resulting from the formation of associated choroidal neovascularization (neovascular AMD);
  • Neovascular complexes characterized by presence of some component of occult CNV in its formation as diagnosed fluorescein angiography and BCVA worse than 20/80;
  • Neovascular complexes with total area of CNV (classic and occult) by fluorescein angiography occupying an area lesser than 50% of the neovascular complex and BCVA worse than 20/80;
  • Direct involvement of the non-vascular foveal zone by the neovascular complex;
  • Term of free informed consent in writing and appropriately signed.

Exclusion criteria:

  • BCVA lesser than 20/400;
  • Greatest linear dimension (GLD) of the neovascular complex larger than 6,000 (six thousand) microns;
  • Previous Photodynamic Therapy (PDT);
  • Thermal laser for the treatment of any CNV;
  • Intra-vitreous injection of corticosteroids or anti-angiogenic drugs;
  • Opacities of the media which can affect significantly the VA, ophthalmic clinical assessment, documentation of the eye fundus and realization of laser therapy;
  • Other causes of CNV such as pathologic myopia (spheric equivalent greater than 6 [six] diopters and/or axial length greater than 26mm), angioid streaks, active uveitis, ocular presumed histoplasmosis and traumatic choroidal rupture;
  • CNV associated to serous/sero hemorrhagic RPED (vascular RPED/hemorrhagic RPED);
  • Absence of identifiable CNV by fluorescein angiography (massive presence of thick blood);
  • CNV with absence of ICG uptake by ICG angiography despite the eligibility of the patient by clinical criteria and fluorescein angiography;
  • Intraocular surgery undertaken in the last 3 months;
  • Posterior vitrectomy or retinopexy with scleral introflexion, at any time;
  • Severe form of non-proliferative Diabetic Retinopathy;
  • Acute ocular infection;
  • Ionizing radiation treatment on the face, skull and neck region;
  • Allergy to fluorescein or indocyanine green;
  • Excessive known use of alcohol or drugs;
  • Medical or psychological conditions which may impede the patient of completing the study or sing the informed consent;
  • Significant uncontrolled disease which, in the opinion of the investigator, may exclude the patient from the study;
  • Impediment or limited legal capability;
  • Participation in other clinical study in the last 30 days. NOTE: Patients who have participated of any clinical study in the last 12 months, even though they had finished their participation prior to the last 30 days, will only be eligible to inclusion if the participation in the present protocol will bring clear benefit to the patient.

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 the Opto i-MP 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 the Opto i-MP 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.

Primary Outcomes:
a) Compare the groups in respect to proportion of eyes that lost less than 15 letters in ETDRS BCVA from baseline at week-54;
b) 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.

Secondary Outcomes:
a) Compare the groups in respect to mean change in ETDRS BCVA
b) Compare the groups in respect to neovascular complex activity (size and CNV leaking area).

 

If you would like further information please go to www.ClinicalTrials.gov
Identifier: NCT00331253