CTRI/2025/10/095593招募中3 期
A Prospective, Multicenter, Randomized, Double-Blind, Parallel-Group, Two-Arm Comparative Clinical Study to evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of R-TPR-051 (RLS-Aflibercept) and Eylea® administered by intravitreal injection in Patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD)
Reliance Life Sciences Pvt. Ltd26 个研究点 分布在 1 个国家目标入组 382 人开始时间: 2026年3月17日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 382
- 试验地点
- 26
- 主要终点
- The primary objective of this study is to demonstrate the equivalence in efficacy of
研究概览
简要总结
This is a prospective, multicenter, double-blind, two-arm, parallel group, active control, randomized, comparative phase III clinical trial. After obtaining written informed consent, subjects will be screened to determine their eligibility forstudy participation. Subjects will be randomised in a 1:1 ratio to receive either RTPR-051 or Eylea® (administered via intravitreal [IVT] injection 2 mg [0.05 mL] every 4 weeks for the first 3 doses (i.e., at Weeks 0, 4, and 8), followed by 2 mg [0.05 mL] once every 8 weeks). At Week 32, subjects in Eylea® treatment group (except those who have consented for PK assessment) will be randomised again in a 1:1 ratio to either continue on Eylea® treatment or be transitioned to R-TPR-051 treatment. In the 8-week treatment cycle, IPs (RTPR-051 or Eylea®) will be administered up to Week 48, and the last assessment will be done at Week 52, corresponding to the end of follow-up for all subjects. A total of 382 patients with neovascular AMD will be enrolled
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.99 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 (BCVA) of 20/40 to 20/200 (letter score of 73 to 34, inclusive) using original series Early Treatment Diabetic Retinopathy Study (ETDRS) charts in the study eye at screening and at week 0 (day 1) prior to randomization 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
- •Non-childbearing potential female (e.g., permanently sterilized, postmenopausal [defined as 12 months with no menses without an alternative medical cause prior to Screening]), OR childbearing potential female subjects or male subjects with their (respectively male or female) partners who agree to use at least two forms of appropriate contraception method that can achieve a failure rate of less than 1% per year (e.g., established use of oral, injected, intravaginal, transdermal, or implanted hormonal contraceptive, placement of an intrauterine device or intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, physical barrier, sexual abstinence) from Screening until 3 months after the last IVT injection of IP.
排除标准
- •Known history of hypersensitivity or allergic reactions to aflibercept or any of its excipients.
- •Study eye: Sub- or intra-retinal haemorrhage that comprises more than 50% of the entire lesion or presence of blood with the size of 1 DA or more involving the centre of fovea (confirmed by the central reading center during screening)
- •Study eye: Scar, fibrosis, or atrophy involving the centre of the fovea (confirmed by the central reading center during screening)
- •Study eye: Presence of CNV due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia (confirmed by the central reading center during screening)
- •Study eye: Presence of retinal pigment epithelial tears or rips involving the macula (confirmed by the central reading center during screening)
- •Study eye: Presence of macular hole at any stage (confirmed by the central reading center during screening)
- •Study eye: Any concurrent macular abnormality other than AMD which could affect central vision or the efficacy of IP including but not limited to epiretinal membrane, vitreomacular traction, macular telangiectasia, retinal vascular abnormality, etc. (confirmed by the central reading center during screening)
- •Study eye: Any concurrent ocular condition which, in the opinion of the Investigator, could either confound the interpretation of efficacy and safety of IP (e.g., ocular media opacities such as significant cataract, optic neuropathy etc.) or require medical or surgical intervention during the study period
- •Either eye: History or clinical evidence of diabetic retinopathy (except for mild nonproliferative diabetic retinopathy) or diabetic macular oedema (DME)
- •Study eye: Current vitreous haemorrhage
- •Either eye: Any previous IVT anti-vascular endothelial growth factor (VEGF) treatment (e.g., bevacizumab, ranibizumab, aflibercept, pegaptanib, etc.)
- •Any previous systemic anti-VEGF treatment
- •Study eye: History of treatment involving macula such as macular laser photocoagulation, photodynamic therapy (PDT), transpupillary thermotherapy (TTT), radiation therapy, or any ocular treatment for neovascular AMD
- •Any systemic treatment or therapy (including prescribed herbal medication) to treat neovascular AMD within 30 days prior to randomisation, and such treatment or therapy will not be allowed during the study period. However, dietary supplements, vitamins, or minerals will be allowed.
- •Study eye: History of vitrectomy, scleral bucking (encircling), glaucoma filtration surgery, corneal transplantation, or pan-retinal photocoagulation
- •Study eye: Previous ocular (intraocular and peribulbar) corticosteroids injection/implant within 1 year prior to randomisation
- •Study eye: Topical ocular corticosteroids administered for less than 30 consecutive days or for more than 60 non-consecutive days within 90 days prior to randomisation.
- •Use of systemic corticosteroids for 30 or more consecutive days within 90 days prior to randomisation (inhaled steroid is permitted)
- •Study eye: Any other intraocular surgery (including cataract surgery or Yttrium Aluminium Garnet [YAG] laser posterior capsulotomy in association with prior posterior chamber intraocular lens [IOL] implantation) or periocular surgery within 90 days prior to randomisation, except for lid surgery, which may not have taken place within 30 days prior to randomisation
- •Current use of medications known to be toxic to the lens, retina, or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin, ethambutol at Screening and such medications will not be allowed during the study period
- •Study eye: Previous radiation therapy near the region of the study eye.
- •Previous participation in clinical studies with IP to treat neovascular AMD in either eye
- •Previous participation in clinical studies with IP to treat disease other than neovascular AMD within 90 days prior to randomisation (excluding dietary supplementary, vitamins, and minerals). Such participation will not be allowed during the study period even if the IP is dietary supplementary, vitamins, or minerals.
- •Subject with only one functional eye (defined as BCVA of counting finger or less on the eye with worse vision)
- •Study eye: Spherical equivalent of the refractive error demonstrating more than 6 diopters of myopia. For subjects who have undergone previous refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 6 diopters of myopia.
- •Study eye: Aphakia or absence of the posterior capsule (unless it occurred as a result of a YAG laser posterior capsulotomy in association with prior posterior chamber IOL implantation)
- •Either eye: Active or suspected ocular and periocular infection at Screening or at randomisation (e.g., infectious blepharitis, infectious conjunctivitis, infection in eyelid) 28 Either eye.
- •Active intraocular inflammation including scleritis at Screening or at randomisation
- •Either eye- History of idiopathic or autoimmune-associated uveitis
- •Study eye: Uncontrolled ocular hypertension (defined as intraocular pressure [IOP] more than 25 mmHg despite treatment with anti-glaucoma medication) at Screening
- •Known allergic reactions and/or hypersensitivity to any component of Eylea® or RTPR-051
- •History of allergy to the fluorescein sodium for injection in angiography
- •History of a medical condition that would preclude scheduled study visits or safe use of IP in the opinion of the Investigator (e.g., history of organ transplant, immunocompromised subject, etc.)
- •Uncontrolled systemic disease including but not limited to uncontrolled diabetes mellitus (in the opinion of the Investigator), uncontrolled systemic hypertension (systolic blood pressure more than 180 mmHg and/or diastolic blood pressure more than 100 mmHg on optimal medical regimen), or uncontrolled atrial fibrillation (resting heart rate more than 110 beats per minutes) at Screening.
- •Stroke, transient ischaemic attacks, or myocardial infarction within 180 days prior to randomisation
- •History of recurrent significant infections and, or current treatment for systemic infection
- •Severe renal impairment with dialysis or a history of renal transplant
- •Malignancy (other than non-melanoma skin cancer) under treatment or with history of metastatic disease.
- •Women of childbearing potential who are pregnant, planning to become pregnant, lactating, or not using adequate birth control, as specified in protocol. For women of childbearing potential, a serum pregnancy test must result negative at Screening.
- •Positive HIV, HBsAg or HCV test at screening.
结局指标
主要结局
The primary objective of this study is to demonstrate the equivalence in efficacy of
时间窗: Change from baseline in Best Corrected Visual Acuity (BCVA) at Week 8
R-TPR-051 compared to Eylea® in subjects with neovascular age-related macular
时间窗: Change from baseline in Best Corrected Visual Acuity (BCVA) at Week 8
degeneration (AMD)
时间窗: Change from baseline in Best Corrected Visual Acuity (BCVA) at Week 8
次要结局
- To evaluate the immunogenicity of R-TPR-051 compared to Eylea: 1. Incidence of anti-drug antibodies (ADAs) to aflibercept(2. Incidence of neutralising antibodies (NAbs) to aflibercept)
- Quality of Life(baseline to Week 32 and Week 52)
- Secondary Outcomes :(1. Change from baseline in BCVA over time)
- Safety Evaluation:(1. Incidence of ocular adverse events (AEs) or serious ocular AEs)
研究者
Dr Ajay Kumar Yadav
Reliance Life Sciences
研究点 (26)
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