Pilot Study of Intravitreal Bevacizumab vs. Combination Therapy for Choroidal Neovascularization Secondary to Causes Other Than Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Mean number of treatments per group
研究概览
简要总结
Anti-VEGF therapy has been proven efficacious for the wet (neovascular) form of macular degeneration and may be beneficial for the treatment of choroidal neovascularization (CNV) due to other causes. The limitation of this type of treatment is the necessity for frequent intraocular injections. The purpose of this study is to determine if using anti-VEGF therapy in combination with photodynamic therapy can reduce the number of treatments needed with monotherapy while achieving similar visual results. There are ongoing multicenter trials evaluating combination therapy in patients with wet AMD but no similar trial for patients with CNV due to non-AMD causes. Therefore, in this study the investigators will focus on patients with CNV not due to AMD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- •Age > 18 years
- •Clinical diagnosis of choroidal neovascularization secondary to the following causes: ocular histoplasmosis, toxoplasmosis, idiopathic, angioid streaks, choroidal ruptures, intraocular inflammation (without signs of active uveitis i.e. multifocal choroiditis), central serous retinopathy and pathologic Myopia.
- •Only one eye will be assessed in the study. If both eyes are eligible, the investigator and patient will determine which eye is to be treated, considering such factors as disease duration, and likelihood of response to treatment.
- •Clear media and dilation to permit good stereo fundus photography
- •Evidence of active CNV present on OCT images manifest by subretinal fluid, intraretinal fluid or retinal thickening ≥ 250 µm
- •Best corrected VA in the study eye must be 20/40 and to 20/400 at 4 meters using ETDRS protocol.
排除标准
- •Pregnancy or lactation
- •Premenopausal women not using adequate contraception The following are considered effective means of contraception: surgical sterilization; use of oral contraceptives; barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel; and IUD; or contraceptive hormone implant or patch.
- •CNV secondary to AMD
- •Diabetic Retinopathy
- •Prior enrollment in clinical studies in the study eye
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- •Previous participation in another simultaneous medical investigation or trial within 1 month preceding Day 0 (excluding vitamins and minerals)
- •Use of drug or treatment related or unrelated to their condition within 30 days prior to enrollment (Verteporfin, pegaptanib, ranibizumab, bevacizumab, triamcinilone or other AMD therapy in study eye)
- •Concurrent use of systemic anti-VEGF therapy
- •Any other ocular condition the investigator believes would pose a significant hazard to the subject if investigational treatment were initiated
- •History of allergy to fluorescein
- •Inability to obtain fundus photographs or FAs of sufficient quality to document CNV
- •Inability to comply with study or follow-up procedures
- •History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.
- •Current treatment for active systemic infection
- •History of uncontrolled glaucoma (defined as intraocular pressure >30mmHg despite treatment with anti-glaucoma medication) or filtering surgery in the study eye
- •Family history of glaucoma
- •Patients who have undergone intraocular surgery within last 2 months
- •Aphakia or absence of the posterior capsule in the study eye Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
研究组 & 干预措施
Monotherapy
Bevacizumab (Avastin; Genentech, Inc.)1.25 mg by intravitreal injection on day 0 and then prn (as-needed) based on ophthalmic examination and OCT findings
干预措施: Bevacizumab (Avastin; Genentech, Inc.) (Drug)
Combination therapy
Intravitreal injection of bevacizumab 1.25 mg (Avastin; Genentech, Inc.) combined with reduced fluence PDT(Visudyne®; Novartis,) and 200 ug of intravitreal dexamethasone(4mg/ml, American regent, Inc) on Day 0 and then monthly retreatment with bevacizumab as-needed and triple therapy every 3 months as-needed.
干预措施: Bevacizumab, Dexamethasone, Verteporfin Photodynamic Therapy (Drug)
结局指标
主要结局
Mean number of treatments per group
时间窗: 12 months
次要结局
- Mean change in visual acuity from baseline(12 months)