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Bevacizumab Intravitreal for Myopic Choroidal Neovascularization

NCT ID: NCT00797992

Last Updated: 2008-11-25

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

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-11-30

Brief Summary

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To evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).

Detailed Description

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Nineteen consecutive patients (19 eyes) with subfoveal PM-CNV, 18 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 1.25 mg bevacizumab or 0.5mg ranibizumab. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. IVTs were repeated only in case of persistent angiographic leakage and if OCT scans showed retinal thickening or edema and serous retinal detachment. The follow-up period was at least 6 months.

Conditions

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Myopic Choroidal Neovascularization

Keywords

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Bevacizumab Myopia Complications Neovascularization OCT

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

Myopic eyes with retinal neovascularization

Group Type EXPERIMENTAL

Injection

Intervention Type DRUG

Intravitreal injection of 1.25 mg bevacizumab

Interventions

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Injection

Intravitreal injection of 1.25 mg bevacizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Myopic CNVM,

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).
* 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.
* Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.
* 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.
* Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Olhos de Goiania

OTHER

Sponsor Role lead

Principal Investigators

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Joao J Nassaralla, PhD

Role: STUDY_CHAIR

Instituto de Olhos de Goiania

Locations

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Instituto de Olhos de Goiania

Goiânia, Goiás, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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JN-05-2008-AR

Identifier Type: -

Identifier Source: org_study_id