OCTA-Directed PDT Triple Therapy for Treatment-Naïve Patients With Exudative Age-Related Macular Degeneration Versus Standard of Care Anti-VEGF(Anti-vascular Endothelial Growth Factor) Monotherapy
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percentage of subretinal exudation resolution
研究概览
简要总结
Optical Coherent Tomography Angiography (OCTA)-Directed PDT Triple Therapy for Treatment-Naïve Patients with Exudative Age-related Macular Degeneration (ARMD) versus Standard of Care Anti-VEGF Monotherapy
详细描述
This study is a 48 week, single center, randomized controlled clinical trial. Approximately 150 subjects will be randomized into three separate arms. This study compares the efficacy of standard of care Lucentis (ranibizumab) monotherapy versus OCTA-Directed PDT Triple Therapy with Lucentis (ranibizumab), PDT with Visudyne (verteporfin), and Triescence (triamcinolone acetonide) in treatment-naïve patients with Exudative Age-Related Macular Degeneration. OCTA-Directed PDT Double Therapy with Lucentis (ranibizumab) and PDT with Visudyne (verteporfin) will also be tested to confirm the hypothesis that steroids are necessary.
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 (Participant)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to give written informed consent
- •Willing and able to comply with all study procedures for the duration of the study.
- •Presence of Exudative ARMD with evidence of choroidal neovascularization: type 1, 2, and/or 3 on spectral domain OCT, fluorescein angiography, indocyanine green angiogram and optical coherent tomography angiography
- •Visual Acuity of 20/25 to 20/400 at screening and baseline visits using an autorefractor or Early Treatment Diabetic Retinopathy Study
- •Intraocular pressure less than or equal to 25mmHG
- •Females of childbearing potential that are willing to use medically acceptable methods of birth control.
排除标准
- •Exudation maculopathies without drusen
- •Previous treatment with macular photocoagulation, anti-VEGF medication or PDT with Visudyne
- •Myocardial infarction or cerebrovascular accident within the last 6 weeks
- •Previous vitrectomy
- •Optic neuropathy
- •Diabetic retinopathy
- •Traction maculopathies
- •Allergies to fluorescein and indocyanine, dilating agents or anti-VEGF medications
- •Have received previous treatment for ARMD
- •Any uncontrolled condition or illness that in the opinion of the investigator makes the subject unsuitable for the study
研究组 & 干预措施
Arm A: Lucentis
A standard of care treatment of 0.05ml/0.5mg Lucentis given every 4 weeks for 48 weeks.
干预措施: Ranibizumab (Drug)
Arm B: Lucentis & PDT Laser
A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence.
干预措施: Ranibizumab (Drug)
Arm B: Lucentis & PDT Laser
A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence.
干预措施: Photodynamic laser treatment (PDT) (Device)
Arm B: Lucentis & PDT Laser
A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence.
干预措施: verteporfin (Drug)
Arm C: Lucentis, PDT Laser and Triescense
A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence and an intravitreal injection of 0.5ml-2mg Triescence at the time of PDT treatment.
干预措施: Ranibizumab (Drug)
Arm C: Lucentis, PDT Laser and Triescense
A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence and an intravitreal injection of 0.5ml-2mg Triescence at the time of PDT treatment.
干预措施: Photodynamic laser treatment (PDT) (Device)
Arm C: Lucentis, PDT Laser and Triescense
A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence and an intravitreal injection of 0.5ml-2mg Triescence at the time of PDT treatment.
干预措施: Triamcinolone Acetonide (Drug)
Arm C: Lucentis, PDT Laser and Triescense
A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence and an intravitreal injection of 0.5ml-2mg Triescence at the time of PDT treatment.
干预措施: verteporfin (Drug)
结局指标
主要结局
Percentage of subretinal exudation resolution
时间窗: 6 months
The percentage of subretinal exudation resolution
Percentage of intraretinal exudation resolution
时间窗: 6 months
The percentage of intraretinal exudation resolution
次要结局
- Percentage of intraretinal exudation resolution(12 months)
- Percentage of subretinal exudation resolution(12 months)
- Best corrected visual acuity (BCVA)(12 months)
- Duration of treatment effect(Up to 6 months)
- Foveal thickness(12 Months)