search
Back to results

Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia

Primary Purpose

Retina, Telangiectasis

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml)
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retina focused on measuring Fovea centralis/pathology, Fundus oculi, Retinal neovascularization, Telangiectasis/diagnosis, Tomography, optical coherence, Vitreous Body/drug effects

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • From the Retina and Vitreous Service, Department of Ophthalmology. Sao Rafael Hospital, Monte Tabor Foudation

Outcomes

Primary Outcome Measures

Visual acuity
Optical coherence tomography
Fluorescein angiography

Secondary Outcome Measures

Full Information

First Posted
March 21, 2007
Last Updated
July 21, 2008
Sponsor
University of Sao Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
search

1. Study Identification

Unique Protocol Identification Number
NCT00451763
Brief Title
Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia
Official Title
Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retina, Telangiectasis
Keywords
Fovea centralis/pathology, Fundus oculi, Retinal neovascularization, Telangiectasis/diagnosis, Tomography, optical coherence, Vitreous Body/drug effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml)
Primary Outcome Measure Information:
Title
Visual acuity
Title
Optical coherence tomography
Title
Fluorescein angiography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Y Takahashi, M.D.
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Otacilio O Maia Jr, M.D.
Organizational Affiliation
Sao Rafael Hospital, Monte Tabor Foudation
Official's Role
Principal Investigator
Facility Information:
Facility Name
From the Retina and Vitreous Service, Department of Ophthalmology. Sao Rafael Hospital, Monte Tabor Foudation
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41253-190
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
17659962
Citation
Maia OO Jr, 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. doi: 10.1016/j.ajo.2007.03.059.
Results Reference
derived

Learn more about this trial

Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia

We'll reach out to this number within 24 hrs