Trial record 19 of 967 for:    "Macular degeneration"

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

This study has been completed.
Sponsor:
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT00531024
First received: September 15, 2007
Last updated: April 20, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Macular Degeneration
Drug: Bevacizumab
Drug: Sodium Chloride
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Systemic Bevacizumab (Avastin) Therapy for Exudative Neovascular Age-Related Macular Degeneration

Resource links provided by NLM:


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:
  • Macular thickness, 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
Experimental: 1
3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals
Drug: Bevacizumab
3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals
Other Name: Avastin
Placebo Comparator: 2
3 intravenous infusions of 100ml sodium chloride 0,9% at 2 weeks intervals
Drug: Sodium Chloride
3 intravenous infusions of 100ml sodium 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 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.

  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

No publications provided

Responsible Party: Prof.Dr. Susanne Binder M.D., Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
ClinicalTrials.gov Identifier: NCT00531024     History of Changes
Other Study ID Numbers: 05-043-0505
Study First Received: September 15, 2007
Last Updated: April 20, 2009
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

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014