MAAM Study: Avastin and Macugen Versus Avastin Versus Macugen

NCT ID: NCT00531336

Last Updated: 2009-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2008-12-31

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.

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.

Conditions

Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Avastin first followed by retreatment of Macugen

Group Type: EXPERIMENTAL

intravitreal injection of Bevacizumab (Avastin)

Intervention Type: DRUG

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

Pegaptanib (Macugen)

Intervention Type: DRUG

0.3 mg intravitreally applied every 6 weeks as long as required

2

Avastin intravitreally every 6 weeks

Group Type: ACTIVE_COMPARATOR

intravitreal injection of Bevacizumab (Avastin)

Intervention Type: DRUG

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

3

Macugen intravitreally every 6 weeks

Group Type: ACTIVE_COMPARATOR

Pegaptanib (Macugen)

Intervention Type: DRUG

0.3 mg intravitreally applied every 6 weeks as long as required

Interventions

intravitreal injection of Bevacizumab (Avastin)

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

Intervention Type: DRUG

Pegaptanib (Macugen)

0.3 mg intravitreally applied every 6 weeks as long as required

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

OTHER

Sponsor Role: lead

Responsible Party

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Principal Investigators

Ilse Krebs, MD

Role: PRINCIPAL_INVESTIGATOR

Ludwig Boltzmann Institute for Biomicroscopic Lasersurgery

Locations

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery

Vienna, Vienna, Austria

Countries

Austria

Other Identifiers

EK06-001839-18

Identifier Type: -

Identifier Source: org_study_id