Manta Study: Avastin Versus Lucentis in Age Related Macular Degeneration

NCT00710229 | Unknown Phase 3

• 1 other identifier: EK 07-192-1007
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration

Keywords

age related macular degeneration; Ranibizumab-Lucentis; Bevacizumab-Avastin

Outcome Measures

Primary Outcomes (1)

• Change of visual acuity over time

  12 months

Secondary Outcomes (1)

• Adverse events retinal thickness (OCT)

  12 months

Study Arms (2)

A

ACTIVE COMPARATOR

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

Drug: Ranibizumab

B

ACTIVE COMPARATOR

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

Drug: Bevacizumab

Interventions

Ranibizumab DRUG

intravitreal injection

Also known as: Lucentis

A

Bevacizumab DRUG

intravitreal injection

Also known as: Avastin

B

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 years
• Active primary or recurrent subfoveal lesion with CNV secondary to AMD

You may not qualify if:

• 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
• Active intraocular inflammation
• Vitreous hemorrhage in the study eye

Sponsors & Collaborators

• The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery: lead
• Krankenanstalt Rudolfstiftung: collaborator
• Medical University of Vienna: collaborator
• Medical University of Graz: collaborator
• Medical University Innsbruck: collaborator
• Krankenhaus der Barmherzigen Brüder Linz: collaborator
• Universitätsaugenklinik Salzburg: collaborator
• Hospital Hietzing: collaborator
• Hanuschkrankenhaus: collaborator

Study Sites (1)

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery

Vienna, Vienna, 1030, Austria

RECRUITING

Related Publications (1)

• Krebs I, Schmetterer L, Boltz A, Told R, Vecsei-Marlovits V, Egger S, Schonherr U, Haas A, Ansari-Shahrezaei S, Binder S; MANTA Research Group. A randomised double-masked trial comparing the visual outcome after treatment with ranibizumab or bevacizumab in patients with neovascular age-related macular degeneration. Br J Ophthalmol. 2013 Mar;97(3):266-71. doi: 10.1136/bjophthalmol-2012-302391. Epub 2013 Jan 3.

  PMID: 23292928 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Ilse Krebs, MD

CONTACT

43-17-1165; Ilse.Krebs@wienkav.at

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 4, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2011
• Last Updated: June 9, 2010

Record last verified: 2010-06

Locations

AU (1)