Systemic Avastin Therapy in Age-Related Macular Degeneration

NCT00531024 | Completed Phase 2

• 1 other identifier: 05-043-0505
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration

Keywords

Exudative Neovascular; AMD; Avastin; Systemic; Exudative Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Lesion size

  6 months

Secondary Outcomes (1)

• Macular thickness, visual acuity

  6 months

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Bevacizumab

2

PLACEBO COMPARATOR

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

Drug: Sodium Chloride

Interventions

Bevacizumab DRUG

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

Also known as: Avastin

1

Sodium Chloride DRUG

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

2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery: lead

Study Sites (1)

Dept. of Ophthalmology, Rudolf Foundation Clinic

Vienna, Vienna, 1030, Austria

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Bevacizumab; Sodium Chloride

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Katharina E Schmid-Kubista, MD

  LBI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2007
• First Posted: September 18, 2007
• Study Start: August 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 22, 2009

Record last verified: 2009-04

Locations

AU (1)