Photodynamic Therapy Using Verteporfin for Treatment of Chronic Central Serous Chorioretinopathy (CSC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- mean change in VA (ETDRS) from baseline to 24 months
研究概览
简要总结
Central serous choroidal (CSC) retinopathy is a disease of the macula characterized by exudation of fluid under the retina localized to the posterior pole as well as loss of vision. The etiology is unknown, but according to the studies this condition is more common in young males and is associated with type A personality. Clinically, CSC is characterized by serous retinal detachment and area of leakage of in the subretinal space. The standard of care for acute CSC is observation for a period of up to 3 months. If there is no complete resolution of the retinal detachment by 3 months, there is an indication for focal laser photocoagulation therapy of the area of leakage. This treatment is usually effective in stopping leakage of fluid under the retina and causing resolution of detachment. However, laser photocoagulation therapy is not beneficial in the treatment of chronic CSC because there is not a single easily identifiable point of leakage but rather diffuse disease of RPE thus rendering laser treatment ineffective.The purpose of this medical research study is to evaluate Verteporfin therapy as an approach which may benefit patients with CSC, based on observations in exudative type of AMD patients treated with Photodynamic Therapy using Verteporfin.
详细描述
7.1 Visit 1 - Screening Visit
The first visit by the patient is for the purpose of screening the patient for the study. This visit must occur within 1 week prior to the treatment visit. At this visit the investigator and the supporting staff will:
- Determine if the patient is eligible for enrollment in the study, explain the study to the patient, and obtain an informed consent from the patient. The form should be witnessed and documented by obtaining the patient's signature at this visit.
- Only one eye of the patient can be enrolled in the study. For patients with lesions in both eyes, the investigator may enroll the eye they deem most eligible or amenable to treatment.
- Record patient demographics, complete medical history and contact information on the initial visit form.
- Perform a complete eye examination including:
i. visual acuity. ii. slit-lamp biomicroscopy. iii. dilated fundus examination. 5. Obtain stereo color fundus photographs (30 degree field of view) of the study eye. 6. Obtain sodium fluorescein angiogram of the study eye via digital imaging system. 7. Obtain ICGA of the study eye. NOTE: If a patient presents with any acute illness during screening and the day of treatment administration, his entry into the study is deferred until the acute illness resolves.
7.2 Visit 2 - Treatment Visit (Day Zero)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Evidence of chronic central serous chorioretinopathy and clinical/angiographic findings typical of the disease of greater than 6 months duration.Chronic central serous chorioretinopathy could be defined on the basis of two factors: a) persistence of the detachment for more than 6 months and b) chronic recurrent acute detachments with widespread decompensation of the retinal pigment epithelium.
- •VA 20/40 and 20/320 Study Eye on the ETDRS visual acuity chart.
- •VA 20/800 or better Fellow Eye on the ETDRS visual acuity chart.
排除标准
- •Patient with tears in retinal pigment epithelium.
- •Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
- •Patients who have undergone intraocular surgery within last 2 months or capsulotomy within last month in study eye.
- •Patient participating in any other investigational drug study.
- •Inability to obtain photographs to document CNV (including difficulty with venous access).
- •Patient with significant liver disease or uremia.
- •Patient with known adverse reaction to indocyanine green or iodine.
- •Patient is pregnant or nursing
- •Age less than 18 years old
结局指标
主要结局
mean change in VA (ETDRS) from baseline to 24 months
时间窗: 24 months
investigate the potential of photodynamic therapy using verteporpin in chronic central serous chorioretinopathy
时间窗: 24 months
次要结局
- mean change of VA(ETDRS), OCT, FA from baseline to 24 months(2 years)