A Prospective, Open-Label Multi Center Trial Evaluating The Safety And Efficacy Of 0.3 Mg/Eye Pegaptanib Sodium (Macugen) Intravitreous Injection Given Every 6 Weeks For 54 Weeks In Patients With Small Neovascular Age-Related Macular Degeneration (AMD) Lesions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)
研究概览
简要总结
To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart), of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in patients with exudative age-related macular degeneration and evidence of recent onset, subfoveal and/or juxtafoveal choroidal neovascularization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and angiographic evidence of juxtafoveal or subfoveal choroidal neovascularization secondary to AMD with a total lesion size of less than 2 MPS disc areas
- •Best-corrected visual acuity in the study eye greater than 54 letters (ETDRS)
- •Women must be using 2 forms of effective contraception
- •Adequate hematological, renal and liver functions
排除标准
- •Any atrophy or fibrosis; any retinal hemorrhage measuring more than 1 disc area
- •Any extrafoveal choroidal neovascularization
- •Any intraocular surgery or thermal laser to the study eye within 3 months of enrollment
- •Previous or concomitant therapy for AMD including PDT with verteporfin (Visudyne) or subfoveal/non-foveal thermal laser therapy, transpupillary thermotherapy, external beam radiation, submacular surgery.
- •Presence of other causes of choroidal neovascularization, including pathological myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis
研究组 & 干预措施
Active
干预措施: pegaptanib sodium (Macugen) (Drug)
结局指标
主要结局
Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)
时间窗: Baseline, 54 Weeks
Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain.
次要结局
- Change From Baseline in Visual Acuity(Baseline, 6 weeks, 12 weeks, 54 weeks)
- Number of Subjects Gaining Vision(54 weeks or at early termination)
- Number of Subjects Maintaining Vision(54 weeks or at early termination)
- Number of Subjects With Severe Visual Loss(54 weeks or at early termination)
- Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)(54 weeks)
- Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).(Baseline, 54 weeks or at early termination)