Trial | NCT00710229  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    320
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.
Study Started
Jul 31
2008
Primary Completion
Dec 31
2011
Anticipated
Last Update
Jun 09
2010
Estimate

Drug Ranibizumab

intravitreal injection

  • Other names: Lucentis

Drug Bevacizumab

intravitreal injection

  • Other names: Avastin

B Active Comparator

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

A Active Comparator

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

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
No Results Posted