Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT00451763

Collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. (Other)

Enrollment

Location

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Retina Telangiectasis	Drug: Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

Visual acuity []
Optical coherence tomography []
Fluorescein angiography []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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