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Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration

NCT ID: NCT01014468

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-02-29

Brief Summary

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To report the short term anatomic and visual acuity response after intravitreal injection of bevacizumab and ranibizumab 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 or 0.5 mg ranibizumab and had a follow-up of at least 3 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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ranibizumab bevacizumab AMD Complications Visual acuity OCt Age Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ranibizumab

Intravitreal injection of Ranibizumab (3 monthly injection followed by monthly injections as long as required)

Group Type ACTIVE_COMPARATOR

Ranibizumab (Intravitreal injection)

Intervention Type DRUG

Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly

Bevacizumab

Intravitreal injection of Bevacizumab (3 monthly injection followed by monthly injections as long as required)

Group Type ACTIVE_COMPARATOR

Bevacizumab (Intravitreal injection)

Intervention Type DRUG

Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly

Interventions

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Ranibizumab (Intravitreal injection)

Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly

Intervention Type DRUG

Bevacizumab (Intravitreal injection)

Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 50 years
* Active primary or recurrent subfoveal lesion with CNV secondary to AMD

Exclusion Criteria

* Prior treatment with any intravitreal drug in the study eye
* Prior treatment with verteporfin photodynamic therapy in the study eye
* Prior treatment with systemic bevacizumab
* Prior treatment with any intravitreal drug or verteporfin photodynamic therapy in the nonstudy eye within the 3 moths before the study entry
* Laser photocoagulation within 1 month before study entry in the study eye
* Previous participation in any clinical trial within 1 month before the entry of the study
* Subfoveal fibrosis or atrophy in the study eye
* CNV in either of the two eye due to causes other than AMD such as histoplasmosis or pathological myopia
* Retinal pigment epithelial tear involving the macula in the study eye
* Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 12 month study period or that could contribute to a loss of best corrected visual acuity over the 12 months study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma). The decision on exclusion is to be based on the opinion of the local principal investigator.
* Active intraocular inflammation
* Vitreous hemorrhage in the study eye
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Olhos de Goiania

OTHER

Sponsor Role lead

Responsible Party

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Joao Nassaralla

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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João J Nassaralla, Jr

Role: STUDY_CHAIR

IOG and UnB

Locations

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Instituto de Olhos de Goiânia

Goiânia, Goiás, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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JJNJ - 8 - 2009

Identifier Type: -

Identifier Source: org_study_id