Early efficacy results favorable for systemic anti-VEGF treatment for CNV

May 4, 2005

Systemic bevacizumab (Avastin) therapy in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration has been associated with functional and anatomic improvements, according to early results from an open-label, uncontrolled clinical study undertaken at Bascom Palmer Eye Institute, Miami, FL.

May 4

- Fort Lauderdale, FL - Systemic bevacizumab (Avastin) therapy in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration has been associated with functional and anatomic improvements, according to early results from an open-label, uncontrolled clinical study undertaken at Bascom Palmer Eye Institute, Miami, FL.

"While this agent appears to have promising efficacy, it has higher systemic risks than any other drugs we are currently using, and we need to determine with further study if its benefits exceed the risks," stated Philip J. Rosenfeld, MD, PhD, who spoke on behalf of the Systemic bevacizumab (Avastin) therapy for Neovascular Age-related macular degeneration (SANA) study group.

Bevacizumab is an anti-VEGF humanized monoclonal antibody that binds to all biologically active isoforms of VEGF. It is commercially available and approved by the FDA for treatment of metastatic colorectal cancer in conjunction with chemotherapy.

One eye of patients enrolled in SANA was identified as the study eye. It was required to have recent disease progression and the patient must have been either not a candidate for verteporfin (Visudyne) photodynamic therapy or refused that treatment. Fifteen of 18 patients had evidence of CNV in their fellow eye.

Six months of follow-up was available for an initial cohort of nine patients and a second cohort of nine patients had been followed for 3 months. Treatment was with the oncology recommended dose of 5 mg/kg, but patients received only two or three doses given at 2-week intervals. Additional treatment was received by three of the first nine patients in the first cohort who had worsening acuity and/or increased retinal thickness.

Results of efficacy analyses performed after 3 to 6 months showed improvements in both study and fellow eyes with CNV with regard to visual acuity, fluorescein and ICG angiography, and OCT-measured central retinal thickness.

The treatment has been well-tolerated so far, but onset or worsening of hypertension occurred in 10 of 18 patients.