Manta Study: Avastin Versus Lucentis in Age Related Macular Degeneration - Full Text View

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

This study is currently recruiting participants.

Verified June 2010 by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

First Received on July 1, 2008. Last Updated on June 8, 2010 History of Changes

Sponsor:	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
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

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 III

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:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Bevacizumab Ranibizumab

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

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 February 09, 2012