Dexamethasone Intravitreal Implant for the Management of Exudative Retinal Detachment in Patients With Uveal Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Ivana K. Kim
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events Related to the Implant
研究概览
简要总结
This is an investigator-initiated Phase I study of a single dose of an intravitreally-administered dexamethasone implant (Ozurdex™) in subjects with uveal melanomas (UM) and exudative retinal detachments (ERD: build-up of fluid under the retina that causes it to detach) being treated with proton beam radiation (PBI) or plaque radiotherapy. Although PBI is an effective treatment for UM, ERDs may persist after radiation, leading to vision loss. Effective treatments for ERD are currently lacking. We are conducting this study to evaluate whether Ozurdex™ can help resolve ERDs that occur in patients with UM. Ozurdex™ has been approved by the Food and Drug Administration (FDA) to treat certain ocular conditions such as macular edema, non-infectious uveitis, and diabetic macular edema but it is not approved for use in patients with UM and ERD. This study will determine the safety of the dexamethasone implant and provide preliminary evidence of efficacy in this population.
详细描述
Study Objective: The primary objective of the study will be to determine the safety of the Ozurdex (dexamethasone) intravitreal implant. The secondary objective is to determine if the implant helps to resolve exudative retinal detachment, a secondary complication associated with uveal melanoma.
Background: This is a single site investigator-initiated Phase I study of a single dose of intravitreally administered dexamethasone implant (Ozurdex™) in subjects with choroidal melanomas and exudative retinal detachments being treated with proton beam irradiation or plaque radiation therapy. This is one of the first studies to evaluate the Ozurdex™ implant in this setting. Therefore the primary goal is to evaluate safety.
Patient Population: Twenty patients will be enrolled in this randomized pilot study. Patients must meet the following eligibility criteria to enroll: Tumor thickness ≤ 10 mm, associated serous retinal detachment > two clock hours in extent, primary treatment of ocular melanoma with proton irradiation or plaque radiotherapy. Males and females >18 years of age are eligible.
Methods: Patients will be randomized (1:1) to receive the dexamethasone implant or no treatment. A stratified randomization scheme will be performed, with strata defined by tumor height (< 5mm and 5mm - ≤ 10 mm). Patients will be masked to their treatment assignment.
Patients will be randomly assigned to receive Ozurdex™ (0.7 mg dexamethasone) or no treatment at either (1) the time of their tumor localization (tantalum ring placement) surgery before proton therapy or (2) their surgery removing the plaque following plaque radiotherapy. A sham treatment procedure to maintain the mask will be unnecessary.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tumor thickness <= 10 mm.
- •Associated serous retinal detachment extending beyond tumor, > two clockhours in extent.
- •Primary treatment of ocular melanoma with proton irradiation or plaque radiotherapy.
排除标准
- •Any pre-existing glaucoma.
- •History of elevated IOP (> 25 mm Hg).
- •History of steroid response glaucoma.
- •Active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva: active ocular herpes simplex, active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
- •Any history of ocular herpes simplex.
- •Torn or ruptured posterior lens capsule.
- •Known hypersensitivity to any components of the dexamethasone intravitreal implant.
- •Women of child-bearing potential: pregnant or planning to become pregnant.
研究组 & 干预措施
Treatment Group
Participants receiving dexamethasone implant.
干预措施: Dexamethasone intravitreal implant (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events Related to the Implant
时间窗: Throughout 12 month study period
The primary outcome of the study will be to evaluate the safety of the implant. All adverse effects not related to the melanoma or radiation treatment identified by ocular examination, diagnostic tests, and subject reporting will be tabulated. This includes significant vision loss, other sight-threatening events, and unforeseen systemic events.
次要结局
- Exudative retinal detachment resolution(6 and 12 months after implant insertion)
- Visual Acuity(6 and 12 months after implant insertion)
- Complications(Throughout 12 month study period.)
研究者
Ivana K. Kim
Associate Professor of Ophthalmology
Massachusetts Eye and Ear Infirmary