Improved vision-related function after ranibizumab vs photodynamic therapy: a randomized clinical trial
Autor: | Tom S. Chang, J. T. Fine, James Ward, Neil M. Bressler, Chantal M. Dolan |
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Rok vydání: | 2009 |
Předmět: |
Male
Vascular Endothelial Growth Factor A medicine.medical_specialty Visual acuity Porphyrins genetic structures Visual Acuity Angiogenesis Inhibitors Antibodies Monoclonal Humanized law.invention Injections Macular Degeneration Randomized controlled trial Double-Blind Method law Ophthalmology Ranibizumab Sickness Impact Profile Surveys and Questionnaires Medicine Humans Fluorescein Angiography Aged Aged 80 and over Photosensitizing Agents business.industry Antibodies Monoclonal Verteporfin Macular degeneration Middle Aged medicine.disease eye diseases Confidence interval Choroidal Neovascularization Clinical trial Vitreous Body Choroidal neovascularization Photochemotherapy Female medicine.symptom business medicine.drug Follow-Up Studies |
Zdroj: | Archives of ophthalmology (Chicago, Ill. : 1960). 127(1) |
ISSN: | 1538-3601 |
Popis: | Objective To compare patient-reported visual function in those with neovascular age-related macular degeneration treated with ranibizumab or verteporfin photodynamic therapy (PDT). Design Multicenter, double-masked, phase 3 trial (ANCHOR). Participants were randomized in a 1:1:1 ratio to receive 0.3 or 0.5 mg of intravitreal ranibizumab plus sham verteporfin or sham injections plus active verteporfin monthly. The National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) was administered at baseline and 1, 2, 3, 6, 9, 12, 18, and 24 months. Main Outcome Measure Mean change from baseline in NEI VFQ-25 scores at 12 months. Results At 12 months, patients treated with ranibizumab (0.3 mg [n = 137] or 0.5 mg [n = 139]) had mean improvements in NEI VFQ-25 composite scores of 5.9 (95% confidence interval [CI], 3.6 to 8.3) and 8.1 (95% CI, 5.3 to 10.8) points, respectively; patients treated with PDT (n = 142) had a mean improvement of 2.2 points (95% CI, −0.3 to 4.7; vs 0.5 mg of ranibizumab, P P = .003). At each dose through 24 months, patients treated with ranibizumab were more likely to improve in most subscales, including the prespecified subscales (near activities, distance activities, and vision-specific dependency). Conclusions Patients treated with ranibizumab were more likely to report clinically meaningful improvements in visual function through 24 months compared with those treated with verteporfin PDT. Application to Clinical Practice Ranibizumab treatment in neovascular age-related macular degeneration can improve patient-reported visual function. Trial Registration clinicaltrials.gov Identifier:NCT00061594 |
Databáze: | OpenAIRE |
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