临床试验/CTRI/2025/08/093929

CTRI/2025/08/093929尚未招募2/3 期

A Phase 2/3, Randomized, Double-Masked, Parallel Group, Multicentre, Comparative Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of Intas Bevacizumab and Ranibizumab Intravitreal Injection in Participants with Neovascular (wet) Age- Related Macular Degeneration

Intas Pharmaceuticals Ltd.30 个研究点分布在 1 个国家目标入组 204 人开始时间: 2025年9月8日最近更新: 2026年3月26日

试验速览

阶段: 2/3 期
状态: 尚未招募
发起方: Intas Pharmaceuticals Ltd.
入组人数: 204
试验地点: 30
主要终点: Phase 2: To assess and compare safety of Intas

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Comparative Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of Intas Bevacizumab and Ranibizumab Intravitreal Injection in Participants with Neovascular (wet) Age-Related Macular Degeneration

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Double

入排标准

年龄范围: 50.00 Year(s) 至 90.00 Year(s)（—）
性别: All

入选标准

•Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study as described in section 10.1.3 and in this protocol and is willing to abide by the requirements during participation in the study.
•Male or and female (assigned at birth, inclusive of all gender identities) 3) Age of greater than or equal to 50 (completed years) at the time of signing the informed consent.
•Primary or recurrent, Anti-VEGF naïve participants with active choroid neovascularization (CNV) lesion involving the central subfield secondary to neovascular (wet) age-related macular degeneration (AMD) in the study eye at Screening as assessed by the investigator.
•Note 1: Active CNV indicates the presence of leakage as evidenced by Fluorescein Angiography (FA) and or intra- or subretinal fluid as evidenced by Optical Coherence Tomography (OCT).
•Note 2: All subtypes of nAMD CNV lesions are permissible (i.e., classic CNV, occult CNV, or with some classic CNV component, or retinal angiomatous proliferation lesions with a CNV component).
•Note 3: If both eyes are affected and eligible, the investigator should consider the worst eye in preference to the other, if the fellow eye can await treatment with anti-VEGF for the duration of study participation.
•BCVA of less than or equal to 73 and greater than or equal to 24 ETDRS letter score (Approximate 20 per 40 and 20 per 320 Snellens equivalent) using Early Treatment Diabetic Retinopathy Study chart (ETDRS) testing at a distance of 4 meters in the study eye at Screening and Baseline.
•Study eye with sufficiently clear ocular media and adequate pupillary dilation that allows for adequate visualization of the fundus with indirect ophthalmoscopy and to permit adequate quality ocular imaging.
•A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of less than 1 precent per year), with low user dependency when used consistently and correctly, as described in section 10.4 during the intervention period and for at least 3 months after the last dose of study intervention.
•The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
•WOCBP agrees not to donate eggs (ova, oocytes), freeze them for future use for reproduction or retrieve them for their own use during the recommended period of contraception.
•A WOCBP must have a negative highly sensitive serum B-human chorionic gonadotropin (BhCG) test at Screening and urine BhCG test at Baseline.
•If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.
•In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
•The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnant 8) Male participants are eligible to participate if they agree to the following during the intervention period and for at least 03 months after the last dose of the study intervention.
•Must agree not to plan to father a child or donate sperm for reproduction; PLUS, Either of the following: Be abstinent from heterosexual [or homosexual] intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent; OR Must agree to use contraception barrier as detailed below: A male participant must wear a condom when engaging in any activity so that condom prevents passage of ejaculate to another person.

排除标准

•Poor quality of SD-OCT and fundus angiography images at Screening Baseline.
•Presence of fibrosis, atrophy or scarring involving fovea in the study eye at Screening as assessed qualitatively by the investigator from CFP FA images.
•Subretinal haemorrhage in the central subfield of the study eye which either (a) involves fovea; or (b) has a total area of greater than or equal to 50 percent of the total lesion area at Screening as assessed qualitatively based on the visual inspection of the CFP by the investigator.
•Total lesion area is defined as contiguous area of abnormal tissue that will include blood, scars, neovascularization, fibrosis and atrophy.
•Any infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis in either eye within 4 weeks prior to Baseline.
•Any active intraocular inflammation (grade trace or above) in the study eye within 4 weeks prior to Baseline.
•History of idiopathic or autoimmune-associated uveitis in either eye.
•CNV in the study eyes due to causes other than AMD such as DME, RVO, histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia (spherical equivalent of -6 dioptres or more negative) or CNV lesion not likely to respond to anti-VEGF.
•Participants with coexisting CNV lesions secondary to AMD in the non-study eye that would require simultaneous treatment with anti-VEGF therapies during the study period.
•Prior interventions in the study eye Prior Treatment with verteporfin, laser photocoagulation, external beam radiation treatment and Transpupillary thermotherapy (a) within 5 years prior to randomization if it involves the fovea in the study eye; OR (b) within 3 months prior to randomization if anywhere beyond fovea in the study eye.
•Prior vitrectomy in the study eye.
•Prior glaucoma filtration surgery in the study eye.
•Prior corneal transplant in the study eye.
•Sub-macular surgery or any surgical intervention for AMD in study eye.
•Prior ocular surgery (including cataract) within the previous 2 months from baseline in the study eye.
•Prior treatment with Any prior anti-VEGF, including but not limited to Ranibizumab, bevacizumab, aflibercept and pegaptanib (intravitreal or systemic) in either eye.
•Previous treatment with intravitreal steroids (e.g., triamcinolone, anecortave acetate) in the study eye within 3 months prior to randomization or intravitreal steroid implant (like Ozurdex) within 6 months prior to randomization.
•Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components excipients thereof [Refer Investigators Brochure (IB) of bevacizumab[5] and Indian Prescribing Information (PI) of Ranibizumab [6]/Summary of Product Characteristics (SmPC) of Ranibizumab[7] ], or to drugs of similar chemical class or to fluorescein or any other component of fluorescein formulation or to topical anaesthetics or mydriatic medications.
•The participant should not be hypersensitive to any of the drugs, components of the drugs, or essential supportive drugs that are required to be used during treatment or evaluation.
•Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine hydroxychloroquine, tamoxifen, phenothiazines and ethambutol.
•History or evidence of the following in the study eye at Screening and or baseline visit: Retinal pigment epithelium (RPE) rip tear involving the macula at Screening or Baseline in the study eye.
•Current vitreous haemorrhage or history of vitreous haemorrhage within 4 weeks prior to Baseline in the study eye.
•Any macular abnormality (including a history of macular hole stage 2 and above) other than AMD at Screening.
•Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) greater than or equal to 30 mmHg despite treatment with antiglaucoma medication) and any such condition for which the investigator feels may require a glaucoma-filtering surgery while in the study.
•For participants who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye does not exceed 8 dioptres of myopia.
•Advanced glaucoma or optic neuropathy that involve(s) or threaten(s) the central visual field in the study eye at Screening or Baseline.
•Aphakia and or absence of the posterior capsule at Screening or Baseline in the study eye Absence of an intact posterior capsule is allowed if it occurred as a result of Yttrium- Aluminium-Garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens (IOL) implantation.
•Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to the first dose of investigational intervention 15) Positive hepatitis C antibody test result at screening or within 3 months prior to starting the investigational intervention.
•NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained.
•For participants with unknown HIV status, HIV testing will be performed at screening unless prohibited by local regulations.
•History of malignancy within the past 5 years except Malignancy treated with curative intent and with no known active disease for at least 3 years before the first dose of study treatment and with low potential risk for risk of metastasis or death (e.g., 5-year OS rate greater than 90 percent).
•Nonmelanoma skin cancer or lentigo maligna who underwent adequate treatment with no active disease at present.
•Adequately treated carcinoma in situ without evidence of disease.
•Localized non-invasive primary disease under surveillance.
•Documented medical history (within 6 months of screening) of thromboembolic events, stroke, cerebral infarction, or transient ischemic attacks, peripheral vascular disease, unstable angina pectoris, congestive heart failure or myocardial infarction, clinically significant cardiac diseases like New York Heart Association (NYHA) Grade II or greater, uncontrolled atrial fibrillation or any other cardiac arrhythmias.
•Documented medical history of bleeding disorders, including platelet disorders, acquired or hereditary coagulations disorders, and acquired or hereditary vascular disorders.
•Uncontrolled hypertension (systolic greater than 160 mm Hg or diastolic greater than 100 mm Hg) despite optimal antihypertensive treatment at screening.
•[If blood pressure is out of range, up to 2 repeated assessments are permitted no more than 60 minutes apart.] Note: Participants may be re-tested or rescreened after initiation or adjustments of antihypertensive medications to establish control.
•Received any other investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days or 5 half-lives prior to the first dose of study intervention, whichever is longer, or is currently enrolled in an investigational study.
•Previous randomization in the current study regardless of having received the investigational intervention or not.
•Any history or evidence of a concurrent intraocular condition in the study eye, including retinal diseases other than neovascular AMD, that in the judgment of the Investigator, could either require medical or surgical intervention during the course of the study to prevent or treat visual loss that might result from that condition or that limits the potential to gain visual acuity upon treatment with the investigational product (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma, uveitis, previous corneal transplant, recent cataract surgery etc.).
•History of a medical condition (disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding) that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product, affect interpretation of the results of the study, or renders the participant at high risk of treatment complications.
•History of gastrointestinal perforation or fistulae, haemorrhage of any kind (e.g. Hemoptysis), arterial or venous thromboembolism, renal disease, history of unhealed wound or ulcers or planned surgery during study conduct period.

结局指标

主要结局

Phase 2: To assess and compare safety of Intas

时间窗: Pre-dose before first dose (Day 1) and third dose (Day 57), Pre-dose before second dose (Day 29), After first dose (Day 1), 8.000, 12.000, 16.000, 20.000, 24.000 28.000 hrs, After third dose (Day 57) 8.000, 12.000, 16.000, 20.000, 24.000 28.000 hrs, Day 85.

bevacizumab with Ranibizumab in participants with wet neovascular AMD.

Phase 3: To assess the noninferiority of Intas

bevacizumab to Ranibizumab in participants with wet neovascular AMD.

次要结局

Phase 2: To assess and compare efficacy(parameters of Intas bevacizumab with)
Phase 2:

研究者

发起方

Intas Pharmaceuticals Ltd.

申办方类型

Pharmaceutical industry-Indian

责任方

Principal Investigator

主要研究者

Dr Naman Shah

Lambda Therapeutic Research Ltd

研究点 (30)

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