- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00451763
Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Bahia
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Salvador, Bahia, Brazil, 41253-190
- From the Retina and Vitreous Service, Department of Ophthalmology. Sao Rafael Hospital, Monte Tabor Foudation
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Visual acuity
|
Fluorescein angiography
|
Optical coherence tomography
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Walter Y Takahashi, M.D., University of Sao Paulo
- Principal Investigator: Otacilio O Maia Jr, M.D., Sao Rafael Hospital, Monte Tabor Foudation
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 165/07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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