Authors' objectives:

The objective of the report was to to assess the usefulness of VEGF inhibitors in the treatment of ARMD.

Authors' results and conclusions: In general, the results analyzed were change in visual acuity , which was measured using a chart with lines containing 5 letters of decreasing sizes. Pegaptanib: The VISION trial randomized 1,186 patients to receive intravitreous injections of pgatanib every 6 weeks (0.3 mg, 1 mg or 3 mg dose) or placebo. At Week 54, the rate of patients with a visual acuity loss fewer than 15 letters was higher in all treatment arms (65-71%; p<0.03) compared to the control (55%). The percentage of patients who maintain or improve their visual acut compared to baseline was also higher in the treatment groups (between 31-37% for ranibizumab groups versus 23% for the control group, p<0.03). During the second year, the number of patients with visual acuity loss of more than 15 letters was significantly lower for the continuous treatment group (7% in the 0.3 mg group), than in those assigned to discontinue treatment after the first year or in those belonging to the control group (14% in both cases, p<0,05). This showed that the benefit of the intervention decreases if discontinued. No differences were found regarding the rate of systemic or extraocular adverse events. Ranibizumab: The MARINA trial included 716 patients with minimally classic or occult neovascularization, who were randomized to receive monthly intravitreous injections of 0.3 mg, 0.5 mg ranibizumab or simulated injections for 2 years. The primary endpoint (rate of patients with visual acuity loss fewer than 15 letters compared to baseline) was 90-92% for ranibizumab and 52.2% for the control group (p<0.001). The secondary endpoint (rate of patients with visual acuity improvement of more than 15 letters compared to baseline) was 26.1-33.3% for ranibizumab and 3.8% for the control group (p<0.001). ANCHOR trial (preliminary results at one year): 423 patients with predominantly classic choroidal neovascularization were randomized to receive intravitreous ranibizumab 0.3 mg or 0.5 mg or verteporfin photodynamic therapy. The rate of patients with visual acuity loss fewer than 15 letters compared to baseline was between 94.3-96.4% for ranibizumab and 64.3% for the verteporfin group (p<0.001). The rate of patients with visual acuity loss improvement more than 15 letters compared to baseline was 35.7-40.3% for ranibizumab and 5.6% for the verteporfin group (p<0.001). FOCUS trial (preliminary results at one year): One hundred and sixty two patients with predominantly classic ARMD were randomized to receive monthly ranibizumab intravitreous injections or simulated injections. In addition, all patients received verteporfin photodynamic therapy. The rate of patients with visual acuity loss fewer than 15 letters compared to baseline was 90.5% for the combined treatment group and 67.9% for the patients who only received verteporfin (p<0.001). The rate of patients with visual acuity loss improvement more than 15 letters compared to baseline was 23.8% for the ranibizumab group plus verteporfin and 5.4% for the verteporfin group (p=0.003). No differences were found regarding the rate of systemic or extraocular adverse events with ranibizumab. Bevacizumab: Several non-controlled trials on the use of this drug for this pathology, both intravenously and intravitreously were found. In some cases, the treatment was combined with photodynamic therapy or pegaptanib. Although satisfactory patient evolution is often described, the differences as regards dosage, short follow-up periods and the absence of a control group do not allow to draw conclusions regarding its safety and/or efficacy. Clinical Practice Guidelines and Recommendations Two guidelines mention pegaptanib and ranibizumab as first line alternatives for the treatment of all kinds of ARMD neovascularizations; mainly for those cases where verteporfin has shown lower efficacy (minimally classic and occult neovascularization). However, ranibizumab is considered to be more efficacious than pegaptanib.

Authors' recommendations: Both pegaptanib and ranibizumab are effective for the treatment of all wet forms of ARMD, and can be considered as first line. Ranibizumab seems to be better than pegaptanib, as the latter not only does it delay or decrease vision loss, but it also causes a great number of patients to have a significant vision improvement. Its use should be limited to subfoveal or juxtafoveal lesions, where laser photocoagulation is not applicable. However, the high cost reported forces to assess their usefulness in this group of patients as regards the available resources health organizations in our country can count on. There is not adequate evidence on the usefulness of bevacizumab. No VEGF inhibitor is indicated for extrafoveal neovascular lesions or in the presence of dry or early ARMD.

Authors' methods: Overview

Project Status: Completed

URL for project: http://www.iecs.org.ar/

Year Published: 2007

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)