Manta Study: Avastin Versus Lucentis in Age Related Macular Degeneration

NCT ID: NCT00710229

Last Updated: 2010-06-09

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

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Brief Summary

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Angiogenesis plays a key role in the development of choroidal neovascularizations (CNV) in age-related macular degeneration. Vascular endothelial growth factor (VEGF) is the most important factor involved in this angiogenetic processes in the eye. This forms the basis for new therapeutic interventions in exudative AMD. Currently two drugs have been approved by the FDA and one drug is used off-label. All these drugs are administered intravitreally. The present study aims to directly compare the effects ranibizumab and bevacizumab in a randomized controlled study in patients with neovascular AMD.

Detailed Description

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Conditions

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Age Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A

Intravitreal injectin of Ranibizumab (3 monthly injection followed by monthly injectins as long as required

Group Type ACTIVE_COMPARATOR

Ranibizumab

Intervention Type DRUG

intravitreal injection

B

Intravitreal injectin of Bevacizumab (3 monthly injection followed by monthly injectins as long as required

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

intravitreal injection

Interventions

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Ranibizumab

intravitreal injection

Intervention Type DRUG

Bevacizumab

intravitreal injection

Intervention Type DRUG

Other Intervention Names

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Lucentis Avastin

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 durg or verteprofin 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 pathologica 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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Krankenanstalt Rudolfstiftung

UNKNOWN

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role collaborator

Medical University Innsbruck

OTHER

Sponsor Role collaborator

Krankenhaus der Barmherzigen Brüder Linz

OTHER

Sponsor Role collaborator

Universitätsaugenklinik Salzburg

UNKNOWN

Sponsor Role collaborator

Hospital Hietzing

OTHER

Sponsor Role collaborator

Hanuschkrankenhaus

UNKNOWN

Sponsor Role collaborator

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

OTHER

Sponsor Role lead

Responsible Party

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The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Locations

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Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Ilse Krebs, MD

Role: CONTACT

43-17-1165 ext. 94682

Facility Contacts

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Ilse Krebs, MD

Role: primary

43-17-1165 ext. 94682

References

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Krebs I, Schmetterer L, Boltz A, Told R, Vecsei-Marlovits V, Egger S, Schonherr U, Haas A, Ansari-Shahrezaei S, Binder S; MANTA Research Group. A randomised double-masked trial comparing the visual outcome after treatment with ranibizumab or bevacizumab in patients with neovascular age-related macular degeneration. Br J Ophthalmol. 2013 Mar;97(3):266-71. doi: 10.1136/bjophthalmol-2012-302391. Epub 2013 Jan 3.

Reference Type DERIVED
PMID: 23292928 (View on PubMed)

Other Identifiers

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EK 07-192-1007

Identifier Type: -

Identifier Source: org_study_id

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