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Completed

NCT Number: NCT00531024

Systemic Avastin Therapy in 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.

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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 / Phase 3

Primary location

Dept. of Ophthalmology, Rudolf Foundation Clinic

Vienna, State of Vienna, 1030, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Bevacizumab

Drug

3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals

Other names: Avastin

Sodium Chloride

Drug

3 intravenous infusions of 100ml sodium chloride 0,9% at 2 weeks intervals

Primary outcomes

  1. Lesion size

    Time frame: 6 months

Secondary outcomes

  1. Macular thickness, visual acuity

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Other

Registry information

Official study title

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

Acronym: BEAT-AMD

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 18, 2007
Registry last updated
Apr 22, 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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