Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia

NCT ID: NCT00451763

Last Updated: 2008-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Retina Telangiectasis

Keywords

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Fovea centralis/pathology Fundus oculi Retinal neovascularization Telangiectasis/diagnosis Tomography, optical coherence Vitreous Body/drug effects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Principal Investigators

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Walter Y Takahashi, M.D.

Role: STUDY_DIRECTOR

University of Sao Paulo

Otacilio O Maia Jr, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sao Rafael Hospital, Monte Tabor Foudation

Locations

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

Salvador, Estado de Bahia, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 17659962 (View on PubMed)

Other Identifiers

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165/07

Identifier Type: -

Identifier Source: org_study_id