Abstract | OBJECTIVE: DESIGN: Multicenter, international, randomized, double-masked, active-treatment-controlled clinical trial. PARTICIPANTS: Patients with predominantly classic, subfoveal CNV not previously treated with PDT or antiangiogenic drugs. INTERVENTION: MAIN OUTCOME MEASURES: The primary, intent-to-treat efficacy analysis was at 12 months, with continued measurements to month 24. Key measures included the percentage losing <15 letters from baseline visual acuity (VA) score (month 12 primary efficacy outcome measure), percentage gaining >or=15 letters from baseline, and mean change over time in VA score and FA-assessed lesion characteristics. Adverse events were monitored. RESULTS: Of 423 patients (143 PDT, 140 each in the 2 ranibizumab groups), the majority (>or=77% in each group) completed the 2-year study. Consistent with results at month 12, at month 24 the VA benefit from ranibizumab was statistically significant (P<0.0001 vs. PDT) and clinically meaningful: 89.9% to 90.0% of ranibizumab-treated patients had lost <15 letters from baseline (vs. 65.7% of PDT patients); 34% to 41.0% had gained >or=15 letters (vs. 6.3% of PDT group); and, on average, 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 ranibizumab (all comparisons P<0.0001 vs. PDT). Overall, there was no imbalance among groups in rates of serious ocular and nonocular adverse events. In the pooled ranibizumab groups, 3 of 277 (1.1%) patients developed presumed endophthalmitis in the study eye (rate per injection = 3/5921 [0.05%]). CONCLUSIONS: FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
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Authors | David M Brown, Mark Michels, Peter K Kaiser, Jeffrey S Heier, Judy P Sy, Tsontcho Ianchulev, ANCHOR Study Group |
Journal | Ophthalmology
(Ophthalmology)
Vol. 116
Issue 1
Pg. 57-65.e5
(Jan 2009)
ISSN: 1549-4713 [Electronic] United States |
PMID | 19118696
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Angiogenesis Inhibitors
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Photosensitizing Agents
- Porphyrins
- Verteporfin
- Ranibizumab
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Topics |
- Aged
- Aged, 80 and over
- Angiogenesis Inhibitors
(therapeutic use)
- Antibodies, Monoclonal
(therapeutic use)
- Antibodies, Monoclonal, Humanized
- Choroidal Neovascularization
(drug therapy, etiology)
- Double-Blind Method
- Female
- Fluorescein Angiography
- Humans
- Injections
- Intraocular Pressure
- Macular Degeneration
(complications, drug therapy)
- Male
- Middle Aged
- Photochemotherapy
- Photosensitizing Agents
(therapeutic use)
- Porphyrins
(therapeutic use)
- Ranibizumab
- Treatment Outcome
- Verteporfin
- Visual Acuity
- Vitreous Body
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