Systemic Avastin Therapy in Age-Related Macular Degeneration - Full Text View

Sponsored by:	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Information provided by:	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:	NCT00531024

Purpose

Choriodal 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.

Condition	Intervention	Phase
Macular Degeneration	Drug: Bevacizumab Drug: Natrium Chloride	Phase II Phase III

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Bevacizumab Chlorides

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Systemic Bevacizumab (Avastin) Therapy for Exudative Neovascular Age-Related Macular Degeneration

Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Primary Outcome Measures:

Lesion size [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Makularthickness, Visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	August 2005
Study Completion Date:	March 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals	Drug: Bevacizumab 3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals
2: Placebo Comparator 3 intravenous infusions of 100ml natrium chloride 0,9% at 2 weeks intervals	Drug: Natrium Chloride 3 intravenous infusions of 100ml natrium chloride 0,9% at 2 weeks intervals

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 natrium chloride 0,9%.

The patients will receive 3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals or 3 intravenous infusions of 100ml natrium 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, Flourescein Angiography, and Indocyanine Angiography will be performed. The follow-up time is 6 months.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531024

Locations

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

Sponsors and Collaborators

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Investigators

Study Director:

Katharina E Schmid-Kubista, MD

LBI

More Information

Responsible Party:	Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery ( Prof.Dr. Susanne Binder M.D. )
Study ID Numbers:	05-043-0505
Study First Received:	September 15, 2007
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00531024
Health Authority:	Austria: Ethikkommission; Austria: Federal Ministry for Health and Women

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Exudative Neovascular
AMD
Avastin
Systemic
Exudative Age-Related Macular Degeneration

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration

Bevacizumab
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs

Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009