CTRI/2021/06/033972已完成4 期
A prospective, multi-center, single arm, open label, study to evaluate safety and efficacy of RanizuRelTM containing Ranibizumab for intra-vitreal injection, manufactured by Reliance Life Sciences, Pvt. Ltd. India in patients with neovascular (wet) age-related macular degeneration.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 21
- 主要终点
- Incidence of adverse events occurring during the study,
研究概览
简要总结
The purpose of this trial is to evaluate safety andefficacy of RanizuRel containing Ranibizumab for intra-vitreal injection ,manufactured by Reliance Life Sciences, Pvt. Ltd. India in patients withneovascular (wet) age-related macular degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients of age ≥ 50 years.
- •Active primary or recurrent subfoveal lesions with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.
- •Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye.
- •Able to understand the study procedures and the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
- •Men and women of childbearing potential must be using adequate birth control measures, as discussed with the study doctor.
排除标准
- •Treatment with verteporfin photodynamic therapy in the study eye within 6 months or in the nonstudy eye within 1 week prior to enrolment.
- •Previous external-beam radiation therapy, transpupillary thermotherapy or subfoveal focal laser photocoagulation in the study eye.
- •Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month prior to enrolment.
- •CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia.
- •History of submacular surgery or other surgical intervention for AMD, previous intravitreal drug delivery or vitrectomy surgery in the study eye.
- •Current vitreous haemorrhage, subretinal hemorrhage that involves the fovea, subfoveal fibrosis or atrophy, active intraocular inflammation or infection in the study eye
- •History of retinal pigment epithelial tear, rhegmatogenous retinal detachment or macular hole (Stage 3 or 4), aphakia or absence of the posterior capsule in the study eye.
- •Uncontrolled glaucoma (defined as intraocular pressure of 30 mmHg or more despite treatment with antiglaucoma medications) or history of glaucoma filtering surgery in the study eye
- •Intraocular surgery (including cataract surgery) within 2 months in the study eye prior to enrolment.
- •Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either require medical or surgical intervention during the study period, or could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity.
- •History of idiopathic or autoimmune-associated uveitis in either eye.
- •Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- •Patients with history of diabetes mellitus.with HbA1c >8% [64 mmol/mol]
- •Patients who are HIV, HBsAg, HCV test positive.
- •Patients with positive urine pregnancy test at screening.
- •Hypersensitivity to ranibizumab or any of the excipients, or history of allergy to fluorescein.
- •Participation in any clinical study of an investigational product within previous 3 months.
- •Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease that renders the patient incapable of participating in the study.
- •History of other disease, active systemic infection, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.
结局指标
主要结局
Incidence of adverse events occurring during the study,
时间窗: at Day 0 , Week 4, Week 8 , Week 12, Week 16, Week 20 , Week 24 and Withdrawal Visit.
次要结局
- •Other safety endpoints:(- SAEs, Serious (sight - threatening)Ocular Adverse Events)
- • Proportion of patients who lost fewer than 15 letters in visual acuity.(at baseline to week 24)
- • Proportion of patients who gained at least 15 letters in visual acuity(at baseline to week 24)
- • Mean change in best corrected visual acuity (no. of letters).(at baseline to week 24)
- • Proportion of patients with a visual acuity Snellen equivalent of 20/40 or better(at baseline to week 24)
- • Proportion of patients with a visual acuity Snellen equivalent of 20/200 or worse(at baseline to week 24)
- • Change in central macular thickness assessed by Optical Coherence Tomography(at baseline to week 24)
研究者
研究点 (21)
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