A prospective, multi-centre, randomized, double blind, parallel, active controlled, phase III study to compare the efficacy, safety, and immunogenicity of Aflibercept of Shilpa Biologicals Private Limited (SBPL) with EYLEA® (Aflibercept) of Bayer AG in subjects with Neovascular Age-related Macular Degeneration (Wet AMD)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 38
- 主要终点
- Proportion of subjects who loose grater than 15 letters (approximately 3 lines) from baseline visual acuity in the study eye.
研究概览
简要总结
This is a prospective, multi-centre, randomized, double blind, parallel, active controlled, phase III study.
The study is planned to be conducted in 180 subjects with Neovascular Age related Macular Degeneration (Wet AMD) (in a ratio of 2:1 i.e. 120 subjects with SBPL Aflibercept and 60 subjects with EYLEA® (Aflibercept) arm).
After signing the informed consent form, the subjects will be screened for confirming the eligibility for study participation.
Subjects will be screened for demographics, physical examination, ophthalmic examination, vital signs, medical history, medication history, 12-lead ECG,
laboratory investigations and urine analysis.
Eligible subjects will be randomized in a ratio of 2:1 i.e. SBPL-Aflibercept or EYLEA® (Aflibercept) arm respectively to enter into the treatment period of 8
weeks. All subjects will receive 2 mg (0.05 mL) of IVT injection on Day 0 and subsequent IVT injection of 2 mg (0.05 mL) on Day 28 and Day 56 (a total of 3
doses).
Each subject will be required to visit the site for a total of 05 visits: Visit 1 – screening visit, Visit 2 –Day 0, Visit 3- Day 28, Visit 4- Day 56 and Visit 5- Day 84; End of the study (EOS) visit). Subjects will report to the clinical site (visit) for investigational product administration on Day 0, Day 28 and Day 56. A window period of ± 2 days is allowed at visit 3, visit 4 and visit 5.
After receiving the last dose of investigational product, subjects will be followed up for a period of 4 weeks and End of Study Assessment will be performed on Day 84.
Each trial subject who requires treatment in the fellow eye as per investigator’s discretion during the study, will be provided standard of care treatment other than anti-VEGF therapy which do not interfere with the endpoint analysis of the study.
The post-trial access of the study drug - test product will be provided free of cost by the sponsor to all the trial subjects, to be taken for 4 to 6 cycles after completion of the trial i.e. Day 84 onwards.
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
- 45.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female participant between 45 and 75 years of age, both inclusive, at the time of screening.
- •2.Subject with active primary or recurrent subfoveal lesion with CNV (choroidal neovascularization) secondary to AMD in the study eye.
- •(Please note: Only one eye will be considered for study.
- •If both eyes are eligible, the one with the better visual acuity will be selected for treatment unless, based on medical reasons, the investigator deemed the other eye to be more appropriate for treatment.
- •If both eyes have similar visual acuity and similar medical reasons, then right eye will be selected) 3.Subjects having a best corrected visual acuity equivalent to Snellen acuity of 20/40 to 20/320 in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) chart for testing at 4 meters.
- •4.Central retinal thickness of ≥300 µm in the study eye as measured by SD-OCT at screening.
- •5.Subjects able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
排除标准
- •Prior treatment with verteporfin or photodynamic therapy in the study eye (except for extrafoveal laser photocoagulation in the study eye) and,or non study eye within past 3 months before study entry.
- •Prior treatment with systemic or intravitreal anti-vascular endothelial growth factor (VEGF) agents within past 6 months before study entry in the study eye.
- •Any prior treatment with systemic or intravitreal anti-VEGF agents in the fellow eye within past 3 months before study entry.
- •Total lesion size grater than 30.5 mm2, including blood, scars, and neovascularization as assessed by fluorescein angiography (FA) in the study eye.
- •Presence of aphakia in study eye.
- •Uncontrolled hypertension defined as systolic blood pressure (BP) grater than 180 mmHg or diastolic BP grater than 100 mmHg under appropriate antihypertensive treatment.
- •Subject with prior treatment within past 3 months before study entry or current treatment with medication which might cause significant detrimental effect in retina i.e., hydroxychloroquine, chloroquine, vigabatrin or amiodarone etc.
- •Prior vitrectomy or laser surgery of the macula (including photodynamic therapy or focal laser photocoagulation) within 1 month before study entry in the study eye.
- •Scar or fibrosis, making up grater than 70percentage of the total lesion in the study eye.
- •Scar, fibrosis, or atrophy involving the centre of the fovea.
- •Sub- or intra-retinal haemorrhage that comprises more than 50% of the entire lesion or presence of blood with the size of 1 DA (disc area) or more involving the centre of fovea in the study eye.
- •History of CNV in either of the two eye due to causes other than AMD such as pathologic myopia (spherical equivalent of 8 diopters or more negative or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study.
- •Retinal pigment epithelial tear involving the macula in the study eye.
- •Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 3 months study period or that could contribute to a loss of best corrected visual acuity over the 3 months study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma, uveitis, previous corneal transplant, recent cataract surgery etc).
- •The decision regarding exclusion is to be based on the opinion of the investigator.
- •Vitreous hemorrhage in the study eye or history of rhegmatogenous retinal detachment or macular hole of Stage 2 and above in the study eye.
- •Any other retinal pathology i.e. Central retinal vein occlusion (CRVO), Central retinal artery occlusion (CRAO) etc.
- •Subjects found positive for any of the serology test for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).
- •Previous participation in any clinical trial within 1 month before the entry of the study.
- •Any other condition that in the opinion of investigator could hamper participation in the study and suspected or confirmed poor compliance as per investigators judgment, in completing the trial and follow up that may make it undesirable for the subject to participate in the study.
- •Pregnant women or breast feeding, or planning to become pregnant while enrolled in the study and for 3 months after the last dose of investigational product.
- •Sexually active subjects and their partners who are of childbearing potential (i.e., neither surgically sterile nor postmenopausal) and not agreeing to use adequate contraception while on study and for 3 months after the last dose of study drug.
结局指标
主要结局
Proportion of subjects who loose grater than 15 letters (approximately 3 lines) from baseline visual acuity in the study eye.
时间窗: Baseline, Visit 5
次要结局
- Proportion of subjects who gain grater than or equal 15 letters (approximately 3 lines) from baseline visual acuity in the study eye [Time Frame: Day 84](Mean change in best corrected visual acuity (BCVA) in the study eye from baseline to end study visit [Time Frame: Day 84])
研究者
P Veerendra Kumar
Shilpa Biologicals Private Limited