MyVisionTest News Archive
Jan 15, 2009
Two-Year Results of the ANCHOR Study
The 2-year results of the ANCHOR clinical trial finds that Lucentis therapy for age-related macular degeneration (AMD) with new-onset, predominantly classic choroidal neovascularization (CNV) is superior to verteporfin photodynamic therapy (PDT).
The ANCHOR study is a 2-year, phase III clinical trial that compared Lucentis (ranibizumab) with PDT in patients with predominantly classic, subfoveal CNV secondary to AMD. At 12 months, Lucentis had superior efficacy to PDT as indicated by both visual acuity (VA) measures and changes in CNV lesion characteristics. The percentage of patients who had lost fewer than 15 letters from baseline VA (primary efficacy end point) was 94.3% and 96.4% in the 0.3-mg and 0.5-mg Lucentis groups, respectively, compared with 64.3% of patients in the PDT group. Also, Lucentis-treated patients, on average, had improved VA compared with baseline at month 12, whereas VA declined in the PDT group. This was the first demonstration that a therapy could not only prevent further VA loss but also provide clinically meaningful improvement of VA in a substantial proportion of patients with predominantly classic CNV.
In the ANCHOR study patients were randomized 1:1:1 to PDT plus monthly sham intraocular injection or to sham verteporfin PDT plus monthly intravitreal ranibizumab (0.3 mg or 0.5 mg) injection. The need for PDT retreatment was evaluated every 3 months using fluorescein angiography (FA).
Of 423 patients (143 PDT, 140 each in the 2 ranibizumab groups), the majority (≥77% in each group) completed the 2-year study. Consistent with results at month 12, at month 24 the VA benefit from Lucentis was statistically significant: 89.9% to 90.0% of Lucentis-treated patients had lost <15 letters from baseline (vs. 65.7% of PDT patients) and 34% to 41.0% had gained ≥15 letters (vs. 6.3% of PDT group). VA was improved from baseline by 8.1 to 10.7 letters (vs. a mean decline of 9.8 letters in PDT group). Changes in lesion anatomic characteristics on FA also favored Lucentis. Overall, there was no imbalance among groups in rates of serious ocular and nonocular adverse events. In the pooled Lucentis groups, 3 of 277 (1.1%) patients developed endophthalmitis in the study eye.
The researchers conclude that Lucentis administered as monthly intravitreal injections of 0.3 mg or 0.5 mg over 24 months was effective, and superior to verteporfin PDT, in maintaining or improving VA in patients with predominantly classic subfoveal neovascular AMD. The VA benefit from ranibizumab was both rapid and sustained: The superiority of ranibizumab to PDT was evident by 1 month after starting treatment, increased to a plateau by the end of the first year, and then persisted through month 24. This represents a major breakthrough in the treatment of predominantly classic CNV secondary to AMD.
The researchers note that patients who completed the ANCHOR study are currently being followed while receiving Lucentis treatment in a 3-year extension study designated HORIZON. The outcome of this longer-term evaluation of the efficacy and adverse events profile of Lucentis in treatment of AMD-associated CNV lesions, using a more flexible, individually adjusted schedule of dosing, will be of great interest.
WHAT IT MEANS TO YOU: ANCHOR is one of the seminal studies of anti-VEGF therapy for AMD. This study demonstrated the ability of Lucentis to improve visual acuity in patients with subfoveal CNV, and the superiority of Lucentis over PDT in the treatment of these lesions. Now complete, the 2-year results confirm earlier data that visual acuity can be stabilized or improved in approximately 90% of patients with subfoveal classic CNV secondary to AMD. This truly is a major breakthrough in the treatment of AMD.
Read more...
Ophthalmology. 2009 Jan;116(1):57-65
Tags: photodynamic therapy, Lucentis, clinical trial, wet AMD
The 2-year results of the ANCHOR clinical trial finds that Lucentis therapy for age-related macular degeneration (AMD) with new-onset, predominantly classic choroidal neovascularization (CNV) is superior to verteporfin photodynamic therapy (PDT).The ANCHOR study is a 2-year, phase III clinical trial that compared Lucentis (ranibizumab) with PDT in patients with predominantly classic, subfoveal CNV secondary to AMD. At 12 months, Lucentis had superior efficacy to PDT as indicated by both visual acuity (VA) measures and changes in CNV lesion characteristics. The percentage of patients who had lost fewer than 15 letters from baseline VA (primary efficacy end point) was 94.3% and 96.4% in the 0.3-mg and 0.5-mg Lucentis groups, respectively, compared with 64.3% of patients in the PDT group. Also, Lucentis-treated patients, on average, had improved VA compared with baseline at month 12, whereas VA declined in the PDT group. This was the first demonstration that a therapy could not only prevent further VA loss but also provide clinically meaningful improvement of VA in a substantial proportion of patients with predominantly classic CNV.
Of 423 patients (143 PDT, 140 each in the 2 ranibizumab groups), the majority (≥77% in each group) completed the 2-year study. Consistent with results at month 12, at month 24 the VA benefit from Lucentis was statistically significant: 89.9% to 90.0% of Lucentis-treated patients had lost <15 letters from baseline (vs. 65.7% of PDT patients) and 34% to 41.0% had gained ≥15 letters (vs. 6.3% of PDT group). VA was improved from baseline by 8.1 to 10.7 letters (vs. a mean decline of 9.8 letters in PDT group). Changes in lesion anatomic characteristics on FA also favored Lucentis. Overall, there was no imbalance among groups in rates of serious ocular and nonocular adverse events. In the pooled Lucentis groups, 3 of 277 (1.1%) patients developed endophthalmitis in the study eye.
The researchers conclude that Lucentis administered as monthly intravitreal injections of 0.3 mg or 0.5 mg over 24 months was effective, and superior to verteporfin PDT, in maintaining or improving VA in patients with predominantly classic subfoveal neovascular AMD. The VA benefit from ranibizumab was both rapid and sustained: The superiority of ranibizumab to PDT was evident by 1 month after starting treatment, increased to a plateau by the end of the first year, and then persisted through month 24. This represents a major breakthrough in the treatment of predominantly classic CNV secondary to AMD.
The researchers note that patients who completed the ANCHOR study are currently being followed while receiving Lucentis treatment in a 3-year extension study designated HORIZON. The outcome of this longer-term evaluation of the efficacy and adverse events profile of Lucentis in treatment of AMD-associated CNV lesions, using a more flexible, individually adjusted schedule of dosing, will be of great interest.
WHAT IT MEANS TO YOU: ANCHOR is one of the seminal studies of anti-VEGF therapy for AMD. This study demonstrated the ability of Lucentis to improve visual acuity in patients with subfoveal CNV, and the superiority of Lucentis over PDT in the treatment of these lesions. Now complete, the 2-year results confirm earlier data that visual acuity can be stabilized or improved in approximately 90% of patients with subfoveal classic CNV secondary to AMD. This truly is a major breakthrough in the treatment of AMD.
Read more...
Ophthalmology. 2009 Jan;116(1):57-65
