CTRI/2024/11/076857尚未招募4 期
A Phase IV, Multicentrer, open-Label, Single-Arm Study in Patients with neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to evaluate the safety and effectiveness of the Faricimab intravitreal Injection in India (VITREAL Study)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 6
- 主要终点
- nAMD & DME: Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This is a Phase IV, Open-Label, Single-Arm Study in Patients With NeoVascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety and Effectiveness of the Faricimab intravitREAL injection in India. The multi-center study is proposed to be conducted at 5 centres across India in about 68 patients. The study duration will be approximately 18 months which include screening and enrollment phase and treatment phase. For each participant the duration of the study will be approximately 5 months (20 weeks). No formal sample size calculation will be performed. 68 patients will be enrolled in the study and will be equally distributed in both cohorts in 1:1 ratio. Descriptive statistics (n, mean, SD, Median, Minimum, and Maximum) will be calculated for continuous data. Categorical data will be depicted with count (%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to provide voluntary written informed consent.
- •Willing and able to comply with clinic visits and study-related procedures.
- •Confirmed diagnosis of neovascular age-related macular degeneration (nAMD; any subtype) or diabetic macular edema in one or both eyes by the study site investigator (only one eye will be selected as the study eye, as determined by the retina specialist) with onset at any time prior to study start.
- •For patients with nAMD: 5a.
- •Active subfoveal choroidal neovascularization secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by OCT in the study eye, as determined by the investigator.
- •Treatment naive.
- •BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the ETDRS protocol and assessed at the initial testing distance of 4 meters on Day
- •For patients with DME: 6a.
- •Patients with clinically significant DME with central involvement (greater than or equal to 325 μm in the Central subfoveal thickness on OCT).
- •BCVA of 73 to 25 letters, inclusive (20/40 to 20/320 approximate Snellen equivalent), using the ETDRS protocol at the initial testing distance of 4 meters on Day
- •HbA1c of less than or equal to 10% within 2 months prior to the Day 1 visit date.
- •Study eye is deemed to be indicated for Faricimab intravitreal treatment at the discretion of the retina specialist.
- •Historical optical coherence tomography data available for the study eye within 30 days prior to Day
- •For female patients of childbearing potential: agree to remain abstinent or use contraception, and agree to refrain from donating eggs, as defined in the protocol.
排除标准
- •Pregnancy or breastfeeding, or intention to become pregnant during the study or within 3 months after the final dose of Faricimab.
- •Requirement on Day 1 for continuous use of any medications and treatments considered prohibited therapy per the protocol.
- •Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals) within 3 months prior to Day
- •Subject with vision only in one eye.
- •Laser photocoagulation in the study eye within 1 month before screening the subject.
- •Stroke or myocardial infarction within 6 months prior to Day
- •History of other diseases, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of Faricimab or renders the patient at high risk for treatment complications in the opinion of the investigator.
- •Uncontrolled hypertension.
- •Patients with cataracts and patients at risk of developing cataracts during the study period Systemic treatment for suspected or active systemic infection on Day 1
- •Legally blind in the study eye on Day 1 (Best-corrected visual acuity of 20/200 or less).
- •History of or any current clinically relevant intraocular inflammation or ocular inflammatory reaction, including non-infectious uveitis or infectious uveitis, or sterile inflammatory reaction after previous IVT injections with any agent in either eye.
- •Suspected or active ocular or periocular infection in either eye on Day
- •Subfoveal fibrosis or Subfoveal atrophy in the study eye.
- •History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular or subconjunctival bleeding or hemorrhages after IVT injection or intraocular procedures in either eye.
- •Uncontrolled glaucoma in the study eye.
- •Prior treatment with any intravitreal drug in the study eye in the past and/or non-study eye within the past 3 months before enrollment in the study.
- •Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation in the study eye at any time during the 3 months prior to Day
- •Any other condition that in the opinion of investigator could hamper participation in the study.
结局指标
主要结局
nAMD & DME: Incidence of treatment-emergent adverse events (TEAEs)
时间窗: baseline to Week 16
次要结局
- nAMD & DME: Mean change from baseline in BCVA in the study eye in patients with nAMD(At Week 16)
- nAMD: Change from baseline in BCVA in the study eye in patients with nAMD over time.(At Baseline, Weeks 4, 8, 12)
- nAMD & DME: Change from baseline in Central subfoveal thickness on OCT in the study eye.(At Week 16)
- nAMD & DME: Change from baseline in Central subfoveal thickness on OCT in the study eye over time.(At Baseline, Weeks 4, 8,12 & 16)
- DME: Change from baseline in BCVA in the study eye in patients with DME over time(At Baseline, Weeks 4, 8,12 & 16)
研究者
研究点 (6)
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