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Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration

NCT ID: NCT00556348

Last Updated: 2011-11-22

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

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-11-30

Brief Summary

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To report the short term anatomic and visual acuity response after intravitreal injection of bevacizumab (Avastin, Roche, Rio de Janeiro, Brazil) in patients with choroidal neovascularization secondary to age-related macular degeneration.

Detailed Description

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We conducted a retrospective study of 500 eyes with choroidal neovascularization secondary to age-related macular degeneration who were treated with at least two (initial and one month after) intravitreal injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. Patients underwent Snellen visual acuity testing, optical coherence tomography (OCT) imaging and ophthalmoscopic examination at baseline and follow-up visits.

Conditions

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Age Related Macular Degeneration

Keywords

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bevacizumab AMD Complications Visual acuity OCt Age Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

bevacizumab

Intervention Type DRUG

1.25mg

Interventions

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bevacizumab

1.25mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
* Myopic CNVM, Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
* Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
* Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.

Exclusion Criteria

* Patients with poor compliance
* Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (\< one year). (Physician clearance was obtained for all patients).
* Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Olhos de Goiania

OTHER

Sponsor Role lead

Responsible Party

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Joao Nassaralla

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joao J Nassaralla, Jr

Role: PRINCIPAL_INVESTIGATOR

UnB and IOG

Other Identifiers

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JN-02-2007-ARVO

Identifier Type: -

Identifier Source: org_study_id