Manta Study: Avastin Versus Lucentis in Age Related Macular Degeneration

Age Related Macular Degeneration Clinical Trial

— MANTA  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00710229
• Other study ID #: EK 07-192-1007
• Status: Recruiting
• Phase: Phase 3
• First received: July 1, 2008
• Last updated: June 8, 2010
• Start date: July 2008

Study information

• Verified date: June 2010
• Source: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
• Contact: Ilse Krebs, MD
• Phone: 43-17-1165
• Email: Ilse.Krebs[@]wienkav.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Ranibizumab
intravitreal injection
• Bevacizumab
intravitreal injection

Locations

Country	Name	City	State
Austria	Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery	Vienna

Sponsors (9)

Lead Sponsor	Collaborator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery	Hanuschkrankenhaus, Hospital Hietzing, Krankenanstalt Rudolfstiftung, Krankenhaus der Barmherzigen Brüder Linz, Medical University Innsbruck, Medical University of Graz, Medical University of Vienna, Universitätsaugenklinik Salzburg

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of visual acuity over time		12 months	Yes
Secondary	Adverse events retinal thickness (OCT)		12 months	Yes