Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia - Full Text View

Sponsors and Collaborators:	University of Sao Paulo Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00451763

Purpose

Idiopathic Macular Telangiectasia is characterized by incompetent and dilated retinal capillaries in the foveolar region of unknown cause for retinal telangiectasia.

In Idiopathic Macular Telangiectasia, proliferative changes occur in the deep retinal capillary network, leading to intraretinal neovascularization that, unlike in age-related macular degeneration, seems to be retinal rather than choroidal in origin. Before the hemorrhagic and fibrotic state, these vessels may lead to exudation and decrease in the visual acuity. Long-term visual prognosis in patients with this complication may be poor and treatment with laser photocoagulation is unproven. Although newly reported treatment, by photodynamic therapy for neovascular membrane associated with Idiopathic Macular Telangiectasia, may show vision and angiographic stability in a few cases, the improvement may be transient. VEGF has been implicated as the major angiogenic stimulus responsible for neovascularization in AMD, ensuing specific anti-VEGF treatment in these cases.

The purpose of the study is to evaluate intravitreal injection of bevacizumab (1.25mg/0.05ml) in the treatment of Idiopathic Macular Telangiectasia.

Condition	Intervention	Phase
Retina Telangiectasis	Drug: Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml)	Phase III

Drug Information available for: Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

Visual acuity
Optical coherence tomography
Fluorescein angiography

Enrollment:	31
Study Start Date:	January 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients with idiopathic macular telangiectasia
patient consent

Exclusion Criteria:

heart attack or cerebrovascular attack
previous treatment for others retinopathy
media opacities that preclude visualization of the fundus
inability to understands the implications of the protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451763

Locations

Brazil, Bahia
From the Retina and Vitreous Service, Department of Ophthalmology. Sao Rafael Hospital, Monte Tabor Foudation
Salvador, Bahia, Brazil, 41253-190

Sponsors and Collaborators

University of Sao Paulo

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Investigators

Study Director:	Walter Y Takahashi, M.D.	University of São Paulo
Principal Investigator:	Otacilio O Maia Jr, M.D.	Sao Rafael Hospital, Monte Tabor Foudation

More Information

Publications indexed to this study:

Maia Junior OO, Bonanomi MT, Takahashi WY, Nascimento VP, Takahashi BS. Intravitreal bevacizumab for foveal detachment in idiopathic perifoveal telangiectasia. Am J Ophthalmol. 2007 Aug;144(2):296-9.

Study ID Numbers:	165/07
Study First Received:	March 21, 2007
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00451763
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:

Fovea centralis/pathology
Fundus oculi
Retinal neovascularization

Telangiectasis/diagnosis
Tomography, optical coherence
Vitreous Body/drug effects

Study placed in the following topic categories:

Retinal Neovascularization
Telangiectasis
Vascular Diseases
Bevacizumab
Neovascularization, Pathologic

Additional relevant MeSH terms:

Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs
Cardiovascular Diseases

Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009