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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery.
Recruitment status was  Recruiting
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
ClinicalTrials.gov Identifier:
NCT00710229
First received: July 1, 2008
Last updated: June 8, 2010
Last verified: June 2010
History of Changes
  Purpose

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 Intervention Phase
Age Related Macular Degeneration
 Drug: Ranibizumab
Drug: Bevacizumab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Primary Outcome Measures:
  • Change of visual acuity over time [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events retinal thickness (OCT) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 320
Study Start Date: July 2008
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710229

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

Locations
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

No publications provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Susanne Binder Prof, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT00710229     History of Changes
Other Study ID Numbers: EK 07-192-1007
Study First Received: July 1, 2008
Last Updated: June 8, 2010
Health Authority: Austria: Ethikkommission

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:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013