NCT00451763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 23, 2008

Status Verified

March 1, 2007

Enrollment Period

11 months

First QC Date

March 21, 2007

Last Update Submit

July 21, 2008

Conditions

RetinaTelangiectasis

Keywords

Fovea centralis/pathologyFundus oculiRetinal neovascularizationTelangiectasis/diagnosisTomography, optical coherenceVitreous Body/drug effects

Outcome Measures

Primary Outcomes (3)

  • Visual acuity

  • Optical coherence tomography

  • Fluorescein angiography

Interventions

Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml)DRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with idiopathic macular telangiectasia
  • patient consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 17659962DERIVED

MeSH Terms

Conditions

TelangiectasisRetinal NeovascularizationDisease

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesRetinal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Walter Y Takahashi, M.D.

    University of Sao Paulo

    STUDY DIRECTOR

  • Otacilio O Maia Jr, M.D.

    Sao Rafael Hospital, Monte Tabor Foudation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 21, 2007

First Posted

March 23, 2007

Study Start

January 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2007

Last Updated

July 23, 2008

Record last verified: 2007-03

Locations

BR(1)