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Ranibizumab Combined With Verteporfin Photodynamic Therapy in Neovascular Age-Related Macular Degeneration
- Source :
- Archives of Ophthalmology. 124:1532
- Publication Year :
- 2006
- Publisher :
- American Medical Association (AMA), 2006.
-
Abstract
- To investigate the safety and efficacy of intravitreal ranibizumab treatment combined with verteporfin photodynamic therapy (PDT) in patients with predominantly classic choroidal neovascularization secondary to age-related macular degeneration.In this 2-year, phase I/II, multicenter, randomized, single-masked, controlled study, patients received monthly ranibizumab (0.5 mg) (n = 106) or sham (n = 56) injections. The PDT was performed 7 days before initial ranibizumab or sham treatment and then quarterly as needed.Proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months (primary efficacy outcome) and the incidence and severity of adverse events.At 12 months, 90.5% of the ranibizumab-treated patients and 67.9% of the control patients had lost fewer than 15 letters (P.001). The most frequent ranibizumab-associated serious ocular adverse events were intraocular inflammation (11.4%) and endophthalmitis (1.9%; 4.8% if including presumed cases). On average, patients with serious inflammation had better visual acuity outcomes at 12 months than did controls. Key serious nonocular adverse events included myocardial infarctions in the PDT-alone group (3.6%) and cerebrovascular accidents in the ranibizumab-treated group (3.8%). CONCLUSION/APPLICATION TO CLINICAL PRACTICE: Ranibizumab + PDT was more efficacious than PDT alone for treating neovascular age-related macular degeneration. Although ranibizumab treatment increased the risk of serious intraocular inflammation, affected patients, on average, still experienced visual acuity benefit.
- Subjects :
- Male
medicine.medical_specialty
Porphyrins
Visual acuity
genetic structures
Visual Acuity
Angiogenesis Inhibitors
Antibodies, Monoclonal, Humanized
law.invention
Macular Degeneration
Randomized controlled trial
law
Ranibizumab
Ophthalmology
medicine
Humans
Single-Blind Method
Prospective Studies
Adverse effect
Prospective cohort study
Aged
Aged, 80 and over
Photosensitizing Agents
business.industry
Antibodies, Monoclonal
Verteporfin
Middle Aged
Macular degeneration
medicine.disease
Choroidal Neovascularization
eye diseases
Treatment Outcome
Choroidal neovascularization
Photochemotherapy
Drug Therapy, Combination
Female
medicine.symptom
business
medicine.drug
Subjects
Details
- ISSN :
- 00039950
- Volume :
- 124
- Database :
- OpenAIRE
- Journal :
- Archives of Ophthalmology
- Accession number :
- edsair.doi.dedup.....dcfc40198bf338aeb0c41658754bd08f
- Full Text :
- https://doi.org/10.1001/archopht.124.11.1532