A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Santen Inc.
- 入组人数
- 60
- 主要终点
- Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye
研究概览
简要总结
The objective of this extension study is to evaluate the long-term safety of treatment with DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the SAKURA development program.
详细描述
This is a multicenter, open-label, extension study of intravitreal injections of the 440 μg dose of DE-109 in subjects with non-infectious uveitis of the posterior segment who received any dose of DE-109 and exited the SAKURA program under Santen Protocol 32-007, Amendment 05.
Subjects who were randomized and received at least two injections of DE-109 during the first five months of the SAKURA program and obtained clinical benefit from the study medication, as determined by the Investigator, may be considered for entry in this 12-month extension study. The minimum time lag from last injection in the SAKURA program to entry into the current protocol is 60 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Participated in the SAKURA study
- •Received clinical benefit from treatment in the SAKURA study
- •Ability to sign informed consent and attend all study visits
排除标准
- •Uveitis of infectious etiology
- •Implanted device
- •Suspected or confirmed central nervous system or ocular lymphoma
- •Uncontrolled glaucoma
- •Significant ocular disease
- •Intravitreal injections in the past 60 days
- •Intraocular surgery or treatment
- •Ocular or periocular infection
- •History of herpetic infection
- •Toxoplasmosis or toxoplasmosis scar
- •Ocular malignancy
- •Allergy or hypersensitivity to study drug
- •Participation in other uveitis device clinical trials within 30 days
- •Any recent systemic condition/infection
- •Immunosuppressive therapy or immunocomprimised
- •Cytomegalovirus infection
- •Malignancy in remission
- •Females who are pregnant or lactating and who are not using adequate contraceptive
- •Medical marijuana or illegal drug use
- •Systemic saroidosis
- •Therapeutic radiation to the head or neck
研究组 & 干预措施
DE-109 Sirolimus
DE-109 440 μg
干预措施: DE-109 440 μg (Drug)
结局指标
主要结局
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye
时间窗: Day 1 (Baseline) and Month 12 or early termination visit
Best Corrected Visual Acuity (BCVA) measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters. An increase in BCVA indicates improvement in the best-corrected vision. A BCVA score of 85 ETDRS letters is equivalent to 20/20 vision, which is considered normal vision.
Mean Change From Baseline in Intraocular Pressure at Month 12 in the Study Eye
时间窗: Day 1 (Baseline) and Month 12 or early termination visit
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg) with one decimal point.
Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye.
时间窗: Day 1 (Baseline) and Month 12 or early termination visit
Ophthalmoscopy findings were reported as normal or abnormal.
Changes From Baseline in Vitreous Haze (VH) Scores at Month 12
时间窗: Day 1 (Baseline) and Month 12 or early termination visit
Vitreous Haze (VH) scores were measured using the modified Standardized Uveitis Nomenclature Photographic Scale (SUN) : 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex) 1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+ 2. Moderate blurring of the optic nerve head 3. Marked blurring of the optic nerve head 4. Optic Nerve head not visible
Number of Subjects Who Receive Rescue Therapy.
时间窗: By Month12
Rescue therapy was defined as any treatment that would have a therapeutic effect on the uveitis in the posterior segment (e.g., systemic treatment with an immunosuppressant agent, or a corticosteroid injection in the study eye) other than intravitreal DE-109 determined by the Investigator.
Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye.
时间窗: Day 1 (Baseline) and Month 12 or early termination visit
Ophthalmoscopy findings were reported as normal or abnormal.
Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye.
时间窗: Day 1 (Baseline) and Month 12 or early termination visit
Ophthalmoscopy findings were reported as normal or abnormal.
Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye.
时间窗: Day 1 (Baseline) and Month 12 or early termination visit
Ophthalmoscopy findings were reported as normal or abnormal.
次要结局
未报告次要终点