Anti-vascular endothelial growth factor therapy for subfoveal choroidal neovascularization secondary to age-related macular degeneration: phase II study results
yucloud 添加于 2012-7-11 10:35
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摘 要
PURPOSE: There is evidence to suggest that anti-vascular endothelial growth factor (anti-VEGF) therapy may be useful in treating ocular neovascularization. A phase IA single intravitreal injection study of anti-VEGF therapy for patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) revealed a good safety profile. We performed a phase II multiple injection study of anti-VEGF therapy with and without photodynamic therapy for patients with subfoveal CNV secondary to AMD to determine the safety profile of multiple injection therapy. DESIGN: A phase II multiple-dose safety study. PARTICIPANTS/METHODS: Twenty-one patients were treated with intravitreal injection with and without photodynamic therapy. MAIN OUTCOME MEASURES: Clinical evidence of toxicity and complications. RESULTS: No drug-related serious adverse events were revealed. Ophthalmic evaluation revealed that 87.5% of patients who received the anti-VEGF aptamer alone showed stabilized or improved vision 3 months after treatment and that 25% of eyes demonstrated a 3 line or greater improvement in vision on the Early Treatment of Diabetic Retinopathy Study chart during this period. A 60% 3 line gain at 3 months was noted in patients who received both the anti-VEGF aptamer and photodynamic therapy. CONCLUSIONS: Anti-VEGF therapy is a promising treatment for various forms of ocular neovascularization, including AMD. Multiple intravitreal injections of the anti-VEGF aptamer were well tolerated in this phase II study. Further clinical trials are necessary to demonstrate the efficacy and long-term safety of anti-VEGF therapy for AMD. -
详细资料
- 关键词: Aged; Aged, 80 and over; Choroidal Neovascularization/*drug therapy/etiology; Combined Modality Therapy; Endothelial Growth Factors/*antagonists & inhibitors; Female; *Fovea Centralis; Humans; Injections; Intercellular Signaling Peptides and Proteins; Lymphokines/*antagonists & inhibitors; Macular Degeneration/*complications; Male; Middle Aged; Oligonucleotides/administration & dosage/adverse effects/*therapeutic use; Photochemotherapy; Photosensitizing Agents/therapeutic use; Porphyrins/therape ...
- 文献种类: Multicenter Study
- 期刊名称: Ophthalmology
- 期刊缩写: Ophthalmology
- 期卷页: 2003年 第110卷 第5期 979-986页
- ISBN: 0161-6420
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