MAAM Study: Avastin and Macugen Versus Avastin Versus Macugen
Information source: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Macular Degeneration
Intervention: intravitreal injection of Bevacizumab (Avastin) (Drug); Pegaptanib (Macugen) (Drug)
Phase: Phase 2
Sponsored by: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Official(s) and/or principal investigator(s):
Ilse Krebs, MD, Principal Investigator, Affiliation: Ludwig Boltzmann Institute for Biomicroscopic Lasersurgery
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.
Official title: Comparison of Combined Therapy of Intravitreal Injection of Avastin and Macugen Versus Mono-Therapy The MAAM Study - a Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: retinal thickness
number of adverse events
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.
Minimum age: 50 Years.
Maximum age: N/A.
- Age > 50 years
- Predominantly occult CNV
- Greatest diameter of the lesion < 5400µm
- Distance acuity > 0. 1
- 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
Locations and Contacts
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery, Vienna A1030, Austria
Starting date: July 2006
Last updated: June 30, 2009