Ranibizumab and Reduced Fluence Photodynamic Therapy for Choroidal Neovascularization in Age Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.
研究概览
简要总结
Single agent anti-VEGF therapies such as ranibizumab have shown great promise and have set the standard for visual outcomes in treating wet macular degeneration. However, they need to be administered frequently by intraocular injections with the attendant risk of endophthalmitis, lens damage, retinal detachment, and vitreous hemorrhage. The purpose of this trial is to see if using photodynamic therapy in combination with ranibizumab will decrease the number of treatments with ranibizumab.
详细描述
A randomized, prospective, multicenter trial will compare two groups of patients with subfoveal choroidal neovascularization secondary to AMD. One group will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year. The other group will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year. Re-treatment will be determined by the individual investigator based on visual acuity, retinal thickness as measured by optical coherence tomography (OCT), and fluorescein angiography. Visual acuity and OCT measurements will be performed by masked examiners.
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
- Single (Outcomes Assessor)
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
- •Willingness to sign informed consent.
- •Age greater than
- •Evidence of macular degeneration in the form of drusen in either eye.
- •Visual acuity of 20/25 to 20/
- •Subfoveal choroidal neovascularization. Both occult and classic subtypes will be allowed. If lesion is purely occult there has to be one of the following:
- •Recent loss of vision (5 letters on ETDRS or doubling of visual angle by snellen)
- •Documented enlargement of lesion on FA
- •Increase of 50 microns or more in the central subfield on OCT
- •Total active lesion must be less than 12 disc areas in size. -
排除标准
- •Myopia, ocular histoplasmosis, or other retinal pathology that could affect vision
- •Previous treatment of the enrolled eye for CNV
- •Intraocular surgery within 6 weeks of enrollment
- •Geographic atrophy, subretinal fibrosis, or pigment epithelial tear involving the fovea of the eligible eye
- •Known hypersensitivity to verteporfin
- •Medical condition that would preclude regular follow-up for one year.
- •Previous vitrectomy
- •Media opacities limiting visual acuity, retinal examination, or retinal imaging.
- •A lesion where > 50% of the lesion is a pigment epithelial detachment. -
研究组 & 干预措施
Group I
Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
干预措施: ranibizumab (Drug)
Group II
Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
干预措施: ranibizumab (Drug)
Group II
Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
干预措施: verteporfin (Drug)
结局指标
主要结局
The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.
时间窗: 1 year
次要结局
- Percentage of Participants With Retreatments Over One Year(1 year)
- Number of Injections Over 12 Months(1 year)
- Percentage of Subjects Gaining More Than 15 ETDRS Letters of Acuity(1 year)
- Improvement in OCT (Optical Coherent Tomography) Foveal Thickness at 12 Months(1 year)