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
  Purpose

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.


Condition Intervention Phase
Macular Degeneration
Drug: intravitreal injection of Bevacizumab (Avastin)
Drug: Pegaptanib (Macugen)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Combined Therapy of Intravitreal Injection of Avastin and Macugen Versus Mono-Therapy The MAAM Study - a Pilot Study

Resource links provided by NLM:


Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Primary Outcome Measures:
  • retinal thickness [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • distance acuity [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]
  • number of adverse events [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: July 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Avastin first followed by retreatment of Macugen
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
Active Comparator: 2
Avastin intravitreally every 6 weeks
Drug: intravitreal injection of Bevacizumab (Avastin)
1.25 mg Avastin intravitreally applied once in arm 1 every 6 weeks in arm 2
Active Comparator: 3
Macugen intravitreally every 6 weeks
Drug: Pegaptanib (Macugen)
0.3 mg intravitreally applied every 6 weeks as long as required

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531336

Locations
Austria
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
Vienna, Austria, A1030
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Investigators
Principal Investigator: Ilse Krebs, MD Ludwig Boltzmann Institute for Biomicroscopic Lasersurgery
  More Information

No publications provided

Responsible Party: Susanne Binder Prof, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT00531336     History of Changes
Other Study ID Numbers: EK06-001839-18
Study First Received: September 15, 2007
Last Updated: June 30, 2009
Health Authority: Austria: Ethikkommission

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
age-related Macular degeneration
Macugen
Avastin

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014