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Completed

NCT Number: NCT00531336

MAAM Study: Avastin and Macugen Versus Avastin Versus Macugen

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.

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery

Vienna, State of Vienna, A1030, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravitreal injection of bevacizumab (Avastin)

Drug

1.25 mg Avastin intravitreally applied once in arm 1 every 6 weeks in arm 2

Pegaptanib (Macugen)

Drug

0.3 mg intravitreally applied every 6 weeks as long as required

Primary outcomes

  1. retinal thickness

    Time frame: 54 weeks

Secondary outcomes

  1. distance acuity

    Time frame: 54 weeks

  2. number of adverse events

    Time frame: 54 weeks

Sponsors and collaborators

Lead sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Other

Registry information

Official study title

Comparison of Combined Therapy of Intravitreal Injection of Avastin and Macugen Versus Mono-Therapy The MAAM Study - a Pilot Study

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 18, 2007
Registry last updated
Jul 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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