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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Opto Eletronica S.A..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Opto Eletronica S.A.
ClinicalTrials.gov Identifier:
NCT00331253
First received: May 26, 2006
Last updated: April 25, 2007
Last verified: April 2007
  Purpose

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


Condition Intervention Phase
Maculopathy, Age-Related
Procedure: Indocyanine Green-Mediated Photothrombosis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Opto Eletronica S.A.:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 280
Study Start Date: April 2007
Estimated Study Completion Date: December 2008
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 50 years;
  • Presence of at least 1 soft drusen in the macular region, associated or not to pigment alterations (hyper- or hypo-pigmentation), thus characterising AMD;
  • Reduction of vision due exclusively to macular exudative processes resulting from the formation of associated choroidal neovascularisation (neovascular AMD);
  • Patients presenting:
  • Neovascular complexes characterised by presence of some occult CNV component in their formation by fluorescein angiography and BCVA worse than 20/80, OR;
  • Neovascular complexes with total CNV (classic and occult) area by fluorescein angiography occupying an area lesser than 50% of the neovascular complex and BCVA worse than 20/80, OR;
  • BCVA lesser than 20/200, regardless of the type of composition of the neovascular complex;
  • Direct involvement of the avascular foveal zone by the neovascular complex;
  • Informed Consent Form in writing and appropriately signed.

Exclusion Criteria:

  • BCVA lesser than 20/400;
  • Greatest linear dimension of the neovascular complex greater than 6000 (six thousand) micron;
  • 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 that can significantly interfere on the VA, clinical ophthalmic assessment, documentation of the eye fundus and performance of laser therapy;
  • Other causes of CNV such as pathologic myopia (spherical equivalent greater than 6 [six] spherical 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 Form;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331253

Contacts
Contact: Elizeu Ramos, M.S. 55 16 33737023 ELIZEU@opto.com.br
Contact: Rogério Costa, M.D. 55 16 33364427 rog.retina@uol.com.br

Locations
Brazil
Universidade Federal de Goias Recruiting
Goiania, Goias/Go, Brazil, 00000
Contact: Avila Marcos, MD    55-16-3252 5566    retina@cbco.com.br   
Contact: David Isaac, MD    55-16-3252 5566    cruvinelisaac@hotmail.com   
Principal Investigator: Avila Marcos, MD         
Sponsors and Collaborators
Opto Eletronica S.A.
Investigators
Study Director: Elizeu Ramos, M.S. Opto Eletrônica S.A.
Principal Investigator: Avila Marcos, MD Universidade Federal de Goias
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00331253     History of Changes
Other Study ID Numbers: 001/04/i-MP
Study First Received: May 26, 2006
Last Updated: April 25, 2007
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Opto Eletronica S.A.:
Indocyanine Green-Mediated Photothrombosis
Neovascular
Age-Related Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 16, 2014