Manta Study: Avastin Versus Lucentis in Age Related Macular Degeneration

Phase 3

• Conditions: Age Related Macular Degeneration
• Interventions: Drug: Bevacizumab; Drug: Ranibizumab

• Registration Number: NCT00710229
• Lead Sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-04
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-08
• Last Update Posted: 2010-06-09
• Primary Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Bevacizumab	Intravitreal injectin of Bevacizumab (3 monthly injection followed by monthly injectins as long as required
A	Ranibizumab	Intravitreal injectin of Ranibizumab (3 monthly injection followed by monthly injectins as long as required

Primary Outcome Measures

Name	Time	Method
Change of visual acuity over time	12 months

Secondary Outcome Measures

Name	Time	Method
Adverse events retinal thickness (OCT)	12 months

Trial Locations

Locations (1)

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery; 🇦🇹 Vienna, Austria