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

Primary Purpose

Age Related Macular Degeneration

Status
Unknown status
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Ranibizumab
Bevacizumab
Sponsored by
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring age related macular degeneration, Ranibizumab-Lucentis, Bevacizumab-Avastin

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ludwig Boltzmann Institute for Retinology and Biomicroscopic LasersurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of visual acuity over time

Secondary Outcome Measures

Adverse events retinal thickness (OCT)

Full Information

First Posted
July 1, 2008
Last Updated
June 8, 2010
Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Collaborators
Krankenanstalt Rudolfstiftung, Medical University of Vienna, Medical University of Graz, Medical University Innsbruck, Krankenhaus der Barmherzigen Brüder Linz, Universitätsaugenklinik Salzburg, Hospital Hietzing, Hanuschkrankenhaus
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1. Study Identification

Unique Protocol Identification Number
NCT00710229
Brief Title
Manta Study: Avastin Versus Lucentis in Age Related Macular Degeneration
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
age related macular degeneration, Ranibizumab-Lucentis, Bevacizumab-Avastin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Intravitreal injectin of Ranibizumab (3 monthly injection followed by monthly injectins as long as required
Arm Title
B
Arm Type
Active Comparator
Arm Description
Intravitreal injectin of Bevacizumab (3 monthly injection followed by monthly injectins as long as required
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
intravitreal injection
Primary Outcome Measure Information:
Title
Change of visual acuity over time
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Adverse events retinal thickness (OCT)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilse Krebs, MD
Phone
43-17-1165
Ext
94682
Email
Ilse.Krebs@wienkav.at
Facility Information:
Facility Name
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
City
Vienna
ZIP/Postal Code
1030
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilse Krebs, MD
Phone
43-17-1165
Ext
94682
Email
Ilse.Krebs@wienkav.at
First Name & Middle Initial & Last Name & Degree
Ilse Krebs, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
23292928
Citation
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.
Results Reference
derived

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Manta Study: Avastin Versus Lucentis in Age Related Macular Degeneration

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