MAAM Study: Avastin and Macugen Versus Avastin Versus Macugen

• Sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery (Other)
• Overall Status: Completed
• CT.gov ID: NCT00531336
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Duration (Months): 29
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Macular Degeneration	Drug: intravitreal injection of Bevacizumab (Avastin); Drug: Pegaptanib (Macugen)	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. retinal thickness [54 weeks]

Secondary Outcome Measures

1. distance acuity [54 weeks]

2. number of adverse events [54 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00531336
• Other Study ID Numbers: EK06-001839-18
• First Posted: Sep 18, 2007
• Last Update Posted: Jul 2, 2009
• Last Verified: Oct 1, 2008

• Keywords provided by , ,: age-related Macular degeneration; Macugen; Avastin
• Additional relevant MeSH terms: Macular Degeneration; Bevacizumab

Study Results

No Results Posted as of Jul 2, 2009