Transpupillary Thermotherapy (TTT) Alone Versus the Combined Therapy Consisting of TTT and Intravitreal Injection of Triamcinolone to Decrease Exudation in Choroidal Melanoma After Proton Beam Therapy
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Decrease of exudation, as indicated by compairing the extent of exudation measured in quadrants in color fundus photographs, autofluorescence imaging, and/or optical coherence tomogaphy.
研究概览
简要总结
Proton beam therapy is a safe irradiation modality for choroidal melanoma. But often after irradiation the exudation increases resulting in an exudative retinal detachment requiring vitreoretinal surgery. It is known that intravitreally injected triamcinolone and TTT is capable to decrease the exudation. If there is any advantage in a combined treatment this study will investigate.
详细描述
Proton beam therapy is an eye preserving irradiation modality for uveal melanoma. After proton beam therapy tumor related lipid exudation and exudative retinal detachment often increase. Therefore vitreoretinal surgery is sometimes required to reattach the retina to protect visual acuity. It is known that intravitreally injected triamcinolone and TTT is capable to decrease exudation. If there is any advantage in a combined treatment and if it is that effective to possibly avoid vitreoretinal surgery this study will investigate.
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
- •exudation (tumor associated exudation/exudative retinal detachment) after proton beam therapy in choroidal melanoma and/or ciliary body melanoma
- •Exclusion criteria:
- •Tumor recurrence
- •Endoresection and / or previous vitrectomy
- •Treatment with anti-angiogenic drugs or intravitreal corticosteroids or any other investigational drug within 3 months prior to randomisation
- •Prior laser photocoagulation treatment within 3 months (focal / grid laser) or 6 months (panretinal) prior to study entry
- •Known hypersensitivity against local anaesthetics
排除标准
- 未提供
研究组 & 干预措施
Transpupillary therapy alone
Transpupillary thermotherapy is performed as monotherapy. It is performed with an infrared diode laser adapted to a slit-lamp biomicroscope at a wavelength of 810 nm and beam diameters of 0.5, 0.8, 1.2, 2.0, or 3.0 mm using a contact lens and through a dilated pupil. Each TTT spot was applied for a duration of about 1 minute to achieve a grayish-white color on the surface of the tumor. TTT could be repeated at intervals of 6-8 weeks with the goal of achieving a complete resolution of fluid
干预措施: Transpupillary thermotherapy (Procedure)
TTT+Triamcinolone Acetonide
transpupillary thermotherapy followed by an intravitreal injection of triamcinolone. It is performed with an infrared diode laser adapted to a slit-lamp biomicroscope at a wavelength of 810 nm and beam diameters of 0.5, 0.8, 1.2, 2.0, or 3.0 mm using a contact lens and through a dilated pupil. Each TTT spot was applied for a duration of about 1 minute to achieve a grayish-white color on the surface of the tumor. After an intravitreal injection of triamcinolone was perfomed under sterile conditions. TTT and triamcinolone injection could be repeated at intervals of 6-8 weeks with the goal of achieving a complete resolution of fluid.
干预措施: Triamcinolone Acetonide (Drug)
TTT+Triamcinolone Acetonide
transpupillary thermotherapy followed by an intravitreal injection of triamcinolone. It is performed with an infrared diode laser adapted to a slit-lamp biomicroscope at a wavelength of 810 nm and beam diameters of 0.5, 0.8, 1.2, 2.0, or 3.0 mm using a contact lens and through a dilated pupil. Each TTT spot was applied for a duration of about 1 minute to achieve a grayish-white color on the surface of the tumor. After an intravitreal injection of triamcinolone was perfomed under sterile conditions. TTT and triamcinolone injection could be repeated at intervals of 6-8 weeks with the goal of achieving a complete resolution of fluid.
干预措施: Transpupillary thermotherapy (Procedure)
结局指标
主要结局
Decrease of exudation, as indicated by compairing the extent of exudation measured in quadrants in color fundus photographs, autofluorescence imaging, and/or optical coherence tomogaphy.
时间窗: 6 weeks, 6 months
次要结局
- Toxic tumor syndrone and required secondary vitrectomy(3 years)
研究者
Dr. Ira Seibel
TTT Versus TTT and Triamcinolone to Decrease Exudation in Choroidal Melanoma After Proton Beam Therapy
Charite University, Berlin, Germany