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

Sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery (Other)

Overall Status

Unknown status

CT.gov ID

NCT00710229

Collaborator

Krankenanstalt Rudolfstiftung (Other), Medical University of Vienna (Other), Medical University of Graz (Other), Medical University Innsbruck (Other), Krankenhaus der Barmherzigen Brüder Linz (Other), Universitätsaugenklinik Salzburg (Other), Hospital Hietzing (Other), Hanuschkrankenhaus (Other)

320

Enrollment

Location

Arms

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2011

Arms and Interventions

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 Names: Lucentis
Active Comparator: B Intravitreal injectin of Bevacizumab (3 monthly injection followed by monthly injectins as long as required	Drug: Bevacizumab intravitreal injection Other Names: Avastin

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 Names:

Lucentis

Active Comparator: B

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

Drug: Bevacizumab

intravitreal injection

Other Names:

Avastin

Outcome Measures

Primary Outcome Measures

Change of visual acuity over time [12 months]

Secondary Outcome Measures

Adverse events retinal thickness (OCT) [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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