Phase II, Randomized, Placebo-Controlled Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline.
研究概览
简要总结
Background:
- Central serous chorioretinopathy (CSC) is a disease that causes fluid to collect under the retina. It affects the macula, which is in the center of the retina and is needed for sharp, clear vision. In many cases, CSC resolves on its own and does not need treatment. However, in some cases it does not go away or comes back after treatment. This is known as chronic CSC.
- Chronic CSC may be caused by hormones called androgens. Finasteride is a drug that can alter the effects certain of androgens. Researchers want to compare finasteride with a placebo to see if it is a safe and effective treatment for chronic CSC.
Objectives:
- To see if finasteride is a safe and effective treatment for chronic CSC.
Eligibility:
- Individuals at least 18 years of age who have chronic CSC in one or both eyes.
Design:
- Participants will be screened with a physical exam and medical history. A full eye exam will be performed. Blood and urine samples will also be collected.
- Some participants may have photodynamic therapy (PDT), the standard treatment for CSC. PDT helps to reduce the amount of fluid in the eye. Participants will need to wait for 3 months after PDT before starting the finasteride study.
- Participants will be separated into two groups. One group will take finasteride 5 mg (formulated into capsules); the other group will take a placebo capsule. All participants will take the capsules for 3 months.
- After 3 months on the assigned capsule (finasteride or placebo), all participants will have the opportunity to take finasteride for at least another 4 years and 9 months. This phase of the study is optional.
- Participants will have regular study visits. At each visit, they will have physical exams and eye exams. They will also provide blood and urine samples.
- During the first 3 months, participants will have 2 study visits. After 3 months, if the participant continues in the optional (or as needed) phase of the protocol, visits will occur at Month 6, Month 12 and every 12 months thereafter. However, additional visits may be needed.
详细描述
Objective:
Central serous chorioretinopathy (CSC) is a chorioretinal disorder characterized by an accumulation of serous fluid under the retina. Although acute CSC tends to resolve spontaneously on its own with minimal sequelae, chronic CSC tends to persist and lead to irreversible visual loss. The pathogenesis of CSC is complex. However, systemic androgens have been implicated. Finasteride is an anti-androgen medication that is widely used in the treatment of various conditions. A previous study performed at the NEI demonstrated a reduction in the amount of subretinal fluid among participants treated with 5 mg of finasteride. The objective of this study is to further investigate the efficacy of oral finasteride as a treatment for chronic CSC.
Study Population:
Thirty-eight participants with chronic CSC are eligible. Up to an additional four participants may be enrolled to account for participants who withdraw from the study prior to Month 3.
Design:
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
- Triple (Participant, Care Provider, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Finasteride 5 mg
Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.
干预措施: Finasteride (Drug)
Placebo
Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline.
时间窗: Month 3
This is the regulatory filing primary outcome measure. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline
时间窗: Month 3
This is the primary outcome measure for publication of study results. Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the "Edit Segmentation" function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume.
次要结局
- Number of Participants With Adverse Reactions Related to the Investigational Product(Duration of the study, up to 1.5 years)
- Number of Participants Who Withdrew From the Study(Duration of the study, up to 1.5 years)
- Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Month 3 Compared to Baseline(Month 3)
- Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at the Safety Visit Compared to Baseline(Final Study Visit)
- Percent Change in Subretinal Fluid Volume in the Study Eye at Month 3 Compared to Baseline(Month 3)
- Changes in Mean Macular Sensitivity in the Study Eye at Month 3 Compared to Baseline(Month 3)
- Changes in Mean Macular Sensitivity in the Study Eye at the Safety Visit Compared to Baseline(Final Study Visit)
- Change in Central Retinal Thickness in the Study Eye at Month 3 Compared to Baseline(Month 3)
- Change in Central Retinal Thickness in the Study Eye at the Safety Visit Compared to Baseline(Final Study Visit)
- Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline(Month 3)
- Change in Serum Dihydrotestosterone (DHT) Concentration at the Safety Visit Compared to Baseline(Final Study Visit)
- Change in Serum Testosterone Concentration at Month 3 Compared to Baseline(Month 3)
- Change in Serum Testosterone Concentration at the Safety Visit Compared to Baseline(Final Study Visit)
- Change in Urinary Levels of Cortisol at Month 3 Compared to Baseline(Month 3)
- Change in Urinary Levels of Cortisol at the Safety Visit Compared to Baseline(Final Study Visit)
- Number of Participants Presenting No Change in Autofluorescence Patterns at Month 3 Compared to Baseline(Month 3)
- Number of Participants Presenting No Change in Autofluorescence Patterns at the Safety Visit Compared to Baseline(Final Study Visit)
- Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at Month 3 Compared to Baseline(Month 3)
- Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at the Safety Visit Compared to Baseline(Final Study Visit)
- Number of Participants Presenting No Change in Fluid Leakage at Month 3 Compared to Baseline(Month 3)
- Number of Participants Presenting No Change in Fluid Leakage at the Safety Visit Compared to Baseline(Final Study Visit)