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

NCT00331253 | Unknown Phase 2 DMC

• 1 other identifier: 001/04/i-MP
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Maculopathy, Age-Related

Keywords

Indocyanine Green-Mediated Photothrombosis; Neovascular; Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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)

Interventions

Indocyanine Green-Mediated Photothrombosis PROCEDURE

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Opto Eletronica S.A.: lead

Study Sites (1)

Universidade Federal de Goias

Goiânia, Goias/Go, 00000, Brazil

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Elizeu Ramos, M.S.

  Opto Eletrônica S.A.

  STUDY DIRECTOR

• Avila Marcos, MD

  Universidade Federal de Goias

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizeu Ramos, M.S.

CONTACT

55 16 33737023; ELIZEU@opto.com.br

Rogério Costa, M.D.

CONTACT

55 16 33364427; rog.retina@uol.com.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 26, 2006
• First Posted: May 29, 2006
• Study Start: April 1, 2007
• Study Completion: December 1, 2008
• Last Updated: April 27, 2007

Record last verified: 2007-04

Locations

BR (1)