NCT00211419已完成1 期
Pilot Study of the Combination of Anecortave Acetate 15mg Delivered by Posterior Juxtascleral Injection and Triamcinolone Acetonide 4mg Delivered by Intravitreal Injection for the Treatment of Exudative Age-Related Macular Degeneration (AMD)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate the safety of combining juxtasclerally administered anecortave acetate 15 mg with triamcinolone acetate 4 mg administered intravitreally following photodynamic therapy with verteporfin for the treatment of exudative age-related macular degeneration (AMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •A male or female with evidence of exudative age-related macular degeneration with clinical/angiographic/optical coherence tomography (OCT) findings of subfoveal choroidal neovascularization (CNV) which has not responded to current therapy
- •Baseline best-corrected visual acuity (BCVA) 20/40 to 20/640
- •Patient must be willing and able to comply with the protocol and provide informed consent.
排除标准
- •Patients on intravenous, subcutaneous, or anticoagulant therapy (with the exception of aspirin and antiplatelet therapy) and cannot take a 5 day holiday from therapy prior to the injection procedure. Note: Patients on oral anticoagulant therapy may be considered to participate if the physician responsible for monitoring the anticoagulant therapy agrees that the patient may take a 5 day holiday from therapy prior to each anecortave injection. The attending doctor must notify the principal investigator and this notification will be made part of the source documentation. Anticoagulant therapy may resume either the evening of or the morning after the injection procedure.
- •Patient with known glaucoma or steroid induced ocular hypertension
- •Intraocular pressures of 21 mmHg or greater at time of entry into the study
- •Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions
- •Patients who have undergone intraocular surgery within last 2 months or capsulotomy within last month in study eye
- •Patient participating in any other investigational drug study
- •Inability to obtain photographs to document CNV (including difficulty with venous access)
- •Concomitant oral steroids or topical ophthalmic steroid use
- •Sub-Tenon's injection of steroids within the past 6 months
- •Patient with significant liver disease or uremia
- •Patient with known adverse reaction to indocyanine green, iodine, verteporfin, or triamcinolone
- •Patient is pregnant or nursing
- •Age less than 50 years old
研究者
研究点 (1)
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