Systemic Avastin Therapy in Age-Related Macular Degeneration (BEAT-AMD)

Systemic Bevacizumab (Avastin) Therapy for Exudative Neovascular Age-Related Macular Degeneration

Choroidal neovascularisation (CNV) in age-related macular degeneration is one of the major causes of blindness in the western world. It is already known that the vascular endothelial growth factor (VEGF) plays a major role in the development of CNV. Photodynamic therapy (PDT), subretinal surgery, and intravitreal injection of VEGF- inhibitors are the common treatments. These methods are either very invasive or need to be repeated several times over long periods of time in order show some effect. Furthermore PDT can only be performed in eyes with pigment epithelium detachments (PED) of maximum 50% of the avascular zone, while intravitreal injections can lead to endophthalmitis and acute glaucoma. A systemic treatment, which would only need to be administered 3 times within 6 weeks would be a major effort in macular degeneration therapy.

Study Overview

Status

Completed

Detailed Description

Bevacizumab (Avastin®, Genentech Inc.) is a new anti-vascular endothelial growth factor (anti-VEGF) which has shown promising results as a combination therapy with 5-fluorouracil, leucovorin, and oxaliplatin in first-line treatment of metastatic colorectal cancer14,15. Since intraocular anti-VEGF therapies for CNV in AMD have already shown promising results, the idea of this study is to administer the anti-VEGF bevacizumab intravenously, as a systemic therapy, in AMD-patients.

The rationale of the present study is to determine the effect of systemic bevacizumab therapy in patients with fibrovascular pigment epithelium detachment (PED), involving the geometric center of the foveal avascular zone, in comparison to placebo treatment with sodium chloride 0,9%.

The patients will receive 3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals or 3 intravenous infusions of 100ml sodium chloride 0,9% at 2 weeks intervals. Medical internal reviews, ETDRS and Radner visual acuity assessment, ophthalmologic examinations, ocular imaging with OCT 3, multifocal ERG, fluorescein angiography, and indocyanine angiography will be performed. The follow-up time is 6 months.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vienna, Austria, 1030
        • Dept. of Ophthalmology, Rudolf Foundation Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • AMD patients with fibrovascular pigment epithelium detachment (PED), subfoveal choroidal neovascularisations (CNV) extending under the geometric center of the foveal avascular zone, and a central retinal thickness of at least 300 microns.

Exclusion Criteria:

  • Patients who had arterial thromboembolic diseases
  • Patients with: Cancer, Proteinuria, Renal impairment, Hepatic dysfunction, Vision threatening ophthalmic diseases other than AMD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals
3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals
Other Names:
  • Avastin
Placebo Comparator: 2
3 intravenous infusions of 100ml sodium chloride 0,9% at 2 weeks intervals
3 intravenous infusions of 100ml sodium chloride 0,9% at 2 weeks intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lesion size
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Macular thickness, visual acuity
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Katharina E Schmid-Kubista, MD, LBI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

September 15, 2007

First Submitted That Met QC Criteria

September 17, 2007

First Posted (Estimate)

September 18, 2007

Study Record Updates

Last Update Posted (Estimate)

April 22, 2009

Last Update Submitted That Met QC Criteria

April 20, 2009

Last Verified

April 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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