MAAM Study: Avastin and Macugen Versus Avastin Versus Macugen

This study has been completed.
Sponsor:
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT00531336
First received: September 15, 2007
Last updated: June 30, 2009
Last verified: October 2008

September 15, 2007
June 30, 2009
July 2006
December 2008   (final data collection date for primary outcome measure)
retinal thickness [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]
retinal thickness [ Time Frame: 54 weeks ]
Complete list of historical versions of study NCT00531336 on ClinicalTrials.gov Archive Site
  • distance acuity [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]
  • number of adverse events [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]
  • distance acuity [ Time Frame: 54 weeks ]
  • number of adverse events [ Time Frame: 54 weeks ]
Not Provided
Not Provided
 
MAAM Study: Avastin and Macugen Versus Avastin Versus Macugen
Comparison of Combined Therapy of Intravitreal Injection of Avastin and Macugen Versus Mono-Therapy The MAAM Study - a Pilot Study

The first results of Anti-Vascular Endothelial Growth Factor (VEGF) therapy were very promising and superior to established therapies. Three different substances (all of them applied intravitreally) are available, but comparative studies have not yet been conducted. In this pilot study, the safety (number of adverse events) and efficacy (distance acuity testing retinal thickness measurement) of Avastin and Macugen applied as monotherapy will be compared to a combined treatment of Avastin followed by Macugen used for retreatment.

At least equal results of the combined therapy are expected.

The role of Vascular Endothelial Growth Factor (VEGF) in the pathogenesis of neovascular diseases like choroidal neovascularization (CNV) and proliferative diabetic retinopathy has been demonstrated in a series of publications. Therefore intravitreally applied VEGF antagonists have been used in the treatment of CNV in age-related macular degeneration (AMD) and diabetic cases. Three anti-VEGFs are available: Macugen® (Pegaptanib), Avastin® (Bevacizumab) and Lucentis® (Ranibizmab). Pegaptanib sodium is an aptamer designed to bind the VEGF 165 isoform with high affinity. Bevacizumab is a humanized monoclonal antibody to VEGF designed for intravenous administration and approved for the treatment of colorectal cancer. Ranibizumab is an anti-body binding site fragment that is derived from the same anti-VEGF antibody as bevacizumab. The decrease of retinal thickness measured in the OCT provides information concerning the amount of intraretinal fluid accumulation and therefore for the activity of a neovascular lesion. It has been proven that the aqueous humor levels of VEGF of eyes with CNV are significantly higher than those of eyes without ocular or systemic diseases. The retinal thickness and the VEGF concentration in the aqueous humor should give a good correlation to the anti vasogenic effect of the intravitreal treatment. In this study bevacizumab and pegaptanib as monotherapy should be compared with a combined therapy of bevacizumab applied first with pegaptanib used for retreatment. The benefit of this combined therapy should be that an initial blockage of all VEGF isoforms is necessary whereas for retreatment the blockage of the most important isoform in the pathogenesis of CNV is sufficient and the normal function of the retinal pigment epithelium and the choriocapillaris is not affected.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Macular Degeneration
  • Drug: intravitreal injection of Bevacizumab (Avastin)
    1.25 mg Avastin intravitreally applied once in arm 1 every 6 weeks in arm 2
  • Drug: Pegaptanib (Macugen)
    0.3 mg intravitreally applied every 6 weeks as long as required
  • Experimental: 1
    Avastin first followed by retreatment of Macugen
    Interventions:
    • Drug: intravitreal injection of Bevacizumab (Avastin)
    • Drug: Pegaptanib (Macugen)
  • Active Comparator: 2
    Avastin intravitreally every 6 weeks
    Intervention: Drug: intravitreal injection of Bevacizumab (Avastin)
  • Active Comparator: 3
    Macugen intravitreally every 6 weeks
    Intervention: Drug: Pegaptanib (Macugen)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 50 years
  • Predominantly occult CNV
  • Greatest diameter of the lesion < 5400µm
  • Distance acuity > 0.1

Exclusion Criteria:

  • Complicating general disorders inflicting with healing process
  • Vision threatening diseases other than CNV
  • Prior treatment for CNV
  • Ophthalmic surgery within 4 weeks
  • Not consented patients
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00531336
EK06-001839-18
No
Susanne Binder Prof, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Not Provided
Principal Investigator: Ilse Krebs, MD Ludwig Boltzmann Institute for Biomicroscopic Lasersurgery
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP