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Manta Study: Avastin Versus Lucentis in Age Related Macular Degeneration (MANTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00710229
Recruitment Status : Unknown
Verified June 2010 by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery.
Recruitment status was:  Recruiting
First Posted : July 4, 2008
Last Update Posted : June 9, 2010
Sponsor:
Collaborators:
Krankenanstalt Rudolfstiftung
Medical University of Vienna
Medical University of Graz
Medical University Innsbruck
Krankenhaus der Barmherzigen Brüder Linz
Universitätsaugenklinik Salzburg
Hospital Hietzing
Hanuschkrankenhaus
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Drug: Ranibizumab Drug: Bevacizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Observer and Subject Masked Trial Comparing the Visual Outcome After Treatment With Ranibizumab or Bevacizumab in Patients With Neovascular Age-related Macular Degeneration Multicenter Anti VEGF Trial in Austria (MANTA)
Study Start Date : July 2008
Estimated Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A
Intravitreal injectin of Ranibizumab (3 monthly injection followed by monthly injectins as long as required
 Drug: Ranibizumab
intravitreal injection
Other Name: Lucentis
Active Comparator: B
Intravitreal injectin of Bevacizumab (3 monthly injection followed by monthly injectins as long as required
 Drug: Bevacizumab
intravitreal injection
Other Name: Avastin


Outcome Measures
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Primary Outcome Measures :
  1. Change of visual acuity over time [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Adverse events retinal thickness (OCT) [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710229


Contacts
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Contact: Ilse Krebs, MD 43-17-1165 ext 94682 Ilse.Krebs@wienkav.at

Locations
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Austria
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery Recruiting
Vienna, Austria, 1030
Contact: Ilse Krebs, MD    43-17-1165 ext 94682    Ilse.Krebs@wienkav.at   
Sub-Investigator: Ilse Krebs, MD         
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Krankenanstalt Rudolfstiftung
Medical University of Vienna
Medical University of Graz
Medical University Innsbruck
Krankenhaus der Barmherzigen Brüder Linz
Universitätsaugenklinik Salzburg
Hospital Hietzing
Hanuschkrankenhaus
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Susanne Binder Prof, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT00710229    
Other Study ID Numbers: EK 07-192-1007
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: June 9, 2010
Last Verified: June 2010
Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
age related macular degeneration
Ranibizumab-Lucentis
Bevacizumab-Avastin
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Ranibizumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors