Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia

Retina Clinical Trial

Official title:

Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451763
• Other study ID #: 165/07
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2007
• Last updated: July 21, 2008
• Start date: January 2006
• Est. completion date: December 2007

Study information

• Verified date: March 2007
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retina
• Telangiectasis

Intervention

Drug:
• Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml)

Locations

Country	Name	City	State
Brazil	From the Retina and Vitreous Service, Department of Ophthalmology. Sao Rafael Hospital, Monte Tabor Foudation	Salvador	Bahia

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity
Primary	Optical coherence tomography
Primary	Fluorescein angiography