Clinical Studies:
Anchor
Citation: Brown DM, Michels M, Kaiser PK, et al. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: two-year results of the ANCHOR study. Ophthalmology 2009; 116: 57-65.
Key Points
- ANCHOR was a randomized, controlled clinical trial of patients with predominantly classic choroidal neovascularization (CNV) from age-related macular degeneration (AMD) that compared monthly ranibizumab 0.3mg or 0.5mg to verteporfin photodynamic therapy (PDT)
- At 24 months, monthly ranibizumab 0.3mg or 0.5mg produced significantly better visual outcomes, with significant visual acuity gains, as compared to verteporfin PDT, which resulted in significant visual acuity loss
- Angiographic anatomic outcomes were likewise better in ranibizumab treated eyes
- Delayed ranibizumab treatment (in PDT group eyes that crossed over at 18 months) stabilized vision, but outcomes were still worse than those treated initially with ranibizumab
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Objective
To study the efficacy of ranibizumab vs. PDT for predominantly classic CNV from AMD
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STUDY DESIGN
Phase 3, multicenter, randomized, double-masked, treatment- controlled trial
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DURATION
24 months
Watch VBS members discuss this study on New Retina Radio Journal Club
With Jorge Fortun, MD; Cynthia Qian, MD; Christina Weng, MD, MBA; and Basil K. Williams, MD
STUDY SUBJECTS
Major inclusion criteria:
- predominantly classic (classic component > 50% of total lesion area) subfoveal CNVM secondary to AMD
Major exclusion criteria:
- permanent structural foveal damage
- history of treatment for subfoveal neovascular AMD that "by its nature or timing might compromise valid assessment of the effects of the study treatment"
RANDOMIZATION SCHEME AND INTERVENTIONS
Randomized 1:1:1 to
(a) verteporfin full-fluence PDT + monthly sham injections
(b) sham verteporfin PDT + monthly intravitreal ranibizumab 0.3mg
(c) sham verteporfin PDT + monthly intravitreal ranibizumab 0.5mg
FA performed every 3 months in all groups and if leakage consistent with CNVM noted, then repeat PDT (active in the PDT group; sham in the ranibizumab groups) administered
Amendment: upon review of 12 month data, PDT patients who had not yet completed the final study visit (23 month) were eligible for crossover to monthly ranibizumab 0.3mg. Those who participated in the amendment received ranibizumab, and no active/sham PDT. Those who did not participate in the amendment continued to receive PDT as per the original randomization scheme.
RESULTS (24 months)
Study population
- 423 patients overall
- Study completion was 77% PDT, 84% ranibizumab 0.3mg, 83% ranibizumab 0.5mg
Visual acuity end-points
- Loss of < 15 letters: 66% PDT vs. ~90% in both ranibizumab groups
- Gain of > 15 letter: PDT 6% vs. 34% ranibizumab 0.3mg, 41% ranibizumab 0.5mg
- Mean VA change: PDT -9.8 letters vs. ranibizumab 0.3mg +8.1 letters, ranibizumab 0.5mg +10.7 letters
Angiographic end-points
- Total lesion, total CNVM areas: essentially stable in ranibizumab groups vs. increased area in the PDT group
Crossover to ranibizumab in the PDT group
- 35% of patients in the PDT group crossed over to monthly ranibizumab at 18 months or later(mean 3.3 injections received by this group)
- Those who crossed over maintained similar VA to VA at time of crossover
- At month 24, for the PDT group, VA change was -5.7 letters in for who crossed over and -12.1 for those who did not
Adverse events
- Rates of any serious and non-serious ocular events, overall, similar between all groups
- "Presumed endophthalmitis": 1% of patients in pooled ranibizumab groups, 0% PDT; 0.05% of injections in the pooled ranibizumab groups, 0% PDT
- No other cases of serious uveitis. Nonserious intraocular inflammation rates higher in ranibizumab groups: 12% ranibizumab 0.3mg, 17% ranibizumab 0.5mg, 4% PDT
- Antiplatelet Trialists' Collaboration criteria (ATCC) events were similar: 4% ranibizumab 0.3mg, 5% ranibizumab 0.5mg, 4% PDT
CONCLUSIONS
Ranibizumab 0.3mg and 0.5mg produced significantly better visual outcomes, compared to PDT, in predominantly classic CNVM from AMD.