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Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00451763
First Posted: March 23, 2007
Last Update Posted: July 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
University of Sao Paulo
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451763


Locations
Brazil
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00451763     History of Changes
Other Study ID Numbers: 165/07
First Submitted: March 21, 2007
First Posted: March 23, 2007
Last Update Posted: July 23, 2008
Last Verified: March 2007

Keywords provided by University of Sao Paulo:
Fovea centralis/pathology
Fundus oculi
Retinal neovascularization
Telangiectasis/diagnosis
Tomography, optical coherence
Vitreous Body/drug effects

Additional relevant MeSH terms:
Telangiectasis
Vascular Diseases
Cardiovascular Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents