Systemic Avastin Therapy in Age-Related Macular Degeneration

Phase 2

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: Sodium Chloride; Drug: Bevacizumab

• Registration Number: NCT00531024
• Lead Sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Brief Summary

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.

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 Timeline

• Study Start: 2005-08
• Study First Submitted: 2007-09-15
• Study First Submitted QC: 2007-09-17
• Study First Posted: 2007-09-18
• Primary Completion: 2008-01
• Study Completion: 2008-03
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-20
• Last Update Posted: 2009-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Sodium Chloride	3 intravenous infusions of 100ml sodium chloride 0,9% at 2 weeks intervals
1	Bevacizumab	3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals

Primary Outcome Measures

Name	Time	Method
Lesion size	6 months

Secondary Outcome Measures

Name	Time	Method
Macular thickness, visual acuity	6 months

Trial Locations

Locations (1)

Dept. of Ophthalmology, Rudolf Foundation Clinic; 🇦🇹 Vienna, Austria