CTRI/2025/05/087515招募中2/3 期
A prospective, multicentre, randomized, open label, two-arm, parallel group, active control, comparative phase II / phase III clinical study to evaluate efficacy, safety and immunogenicity of R-TPR-023 (RLS-Bevacizumab) / Accentrix® (Ranibizumab) in patients with neovascular (wet) age-related macular degeneration
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 202
- 试验地点
- 13
- 主要终点
- Proportion of patients who lost fewer than 15 letters in visual acuity from baseline to week 16
研究概览
简要总结
This is a phase II/ phase III, prospective, multicentre, open label, two-arm, noninferiority, parallel group, active control, randomized, comparative clinical study to evaluate efficacy, safety and immunogenicity of R-TPR-023 (RLS-Bevacizumab)/ Accentrix® (Ranibizumab) in patients with neovascular (wet) age-related macular degeneration. In phase II, total 70 subjects will be enrolled in 1:1 ratio (35 in RLS Bevacizumab group and 35 in Accentrix group). In phase III study, 132 patients with wet AMD will be enrolled in 2:1 ratio (88 in Bevacizumab group and 44 in Accentrix® group)
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients of age more than or equal to 50 years.
- •Active primary or recurrent subfoveal lesions with classic or occult 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.
- •Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential.
排除标准
- •Treatment with verteporfin photodynamic therapy in the study eye within 6 months or in the non-study eye within 1 week prior to randomization.
- •Previous external-beam radiation therapy, trans-pupillary thermotherapy or subfoveal focal laser photocoagulation in the study eye.
- •Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month prior to randomization.
- •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 randomization
- •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 controlled or uncontrolled diabetes mellitus.
- •PT and aPTT 1.5 times of ULN
- •Patients who are HIV, HBsAg, HCV test positive.
- •Female patients with positive serum pregnancy test at screening.
- •Prior use of study medication (ranibizumab or bevacizumab); hypersensitivity to ranibizumab/bevacizumab or any of the excipients in study medication, or history of allergy to fluorescein.
- •Use of any other anti-VEGF agents within 3 months or 5 half-lives whichever is longer
- •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 which in the opinion of the investigator will render 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
Proportion of patients who lost fewer than 15 letters in visual acuity from baseline to week 16
时间窗: Proportion of patients who lost fewer than 15 letters in visual acuity from baseline to week 16
次要结局
- Proportion of patients who lost fewer than 15 letters in visual acuity from baseline to week 24(Day1, week 1, week 4, week 8, week 12 week 16, week 20, Week 24)
- Proportion of patients who gained at least 15 letters in visual acuity from baseline to week 24(Day1, week 1, week 4, week 8, week 12 week 16, week 20, Week 24)
- Mean change in best corrected visual acuity (number of letters) from baseline to week 24(Day1, week 1, week 4, week 8, week 12 week 16, week 20, Week 24)
- Proportion of patients with a visual acuity Snellen equivalent of 20/40 or better from baseline to week 24(Day1, week 1, week 4, week 8, week 12 week 16, week 20, Week 24)
- Change in central macular thickness assessed by Optical Coherence Tomography from baseline to week 24(Day1, week 1, week 4, week 8, week 12 week 16, week 20, Week 24)
- Proportion of patients with a visual acuity Snellen equivalent of 20/200 or worse from baseline to week 24(Day1, week 1, week 4, week 8, week 12 week 16, week 20, Week 24)
- Evaluation of Safety(Day 1, week 1, week 4, week 8, week 12 week 16, week 20, Week 24)
- Immunogenecity Assessment(Day 1, week 1, week 16, week 24)
研究者
Dr Ajay Kumar Yadav
Reliance life sciences
研究点 (13)
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