CTRI/2023/03/050806 [Registered on: 17/03/2023] Trial Registered Prospectively
Last Modified On:
07/05/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Clinical trial to Compare the Efficacy, Safety, and Immunogenicity of Lupin’s Aflibercept with Eylea® in Patients with Neovascular Age-Related Macular Degeneration
Scientific Title of Study
A Phase III, Prospective, Randomized, Parallel group, Double-blind, Multicentre Study to Compare the Efficacy, Safety, and Immunogenicity of Lupin’s Aflibercept with Eylea® in Patients with Neovascular Age-Related Macular Degeneration
Ethics Commitee,Sanjeevani Cancer Hospital, Sanjeevani CBCC USA Cancer Hospital, Front Of Jain Mandir Dawada Colony, Pachpedi Naka, Raipur, Chhattishgarh-492001
Approved
Ethics Committee of CIMS Care Institute of Medical Sciences Care Institute of Medical Sciences Nr. Shukan Mall, Off Science City Road, Sola Ahmedabad Ahmedabad Gujarat
Approved
Ethics Committee, Dr D. Y. Patil vidyapeeth, sant Tukaram Nagar, Pimpri, Pune 411018 Maharshtra India
Approved
G.V. Meditech Ethics Committee, G. V. Meditech Pvt.Ltd.,B-38/46-H, Raman Nivas, Mahmoorganj Varanasi-221010
Approved
IHEC PSG IMS&R, Academic Block, 1st Floor, PSG Institute of Medical Science & Resesrch Centre, Avinashi Road, Peelamedu, Coimbtore-641004, Tamilnadu, India
Approved
Instituational Ethics Commitee, GMERS medical college Sola, S-G Highway Near Gujarat High Court Ahmedabad Gujarat 380060 India
Approved
Instituational Ethics Committee Arvind Eye Hospital, No.1 Anna Nagar, Madhurai-625020, Tamilnadu, India
Approved
Instituational Ethics Committee of Amrita Institute of Medical Science & Research, Ponekkara, P.O Kochi-682041
Approved
Instituational Ethics Committee, Room 6006,B block,PGIMER, Chandigarh 160012 India
Approved
Instituational Ethics Committee, Sri Guru Ram Das Institute of Medical Sciences & Research, VPO vallah, Mehta Road Amritsar-143006, Punjab India
Approved
Instituational Ethics, Committee NKP Salve Institute of Medical Sciences & Lata Mangeshkar Hospital, Digdoh Hills, Hingna -440019,Nagpur, Maharashtra
Approved
Institute Ethics Commitee, Room No -2013, 2nd Floor South Wing Medical College Complex, Gate No 5, All India Institute of Medical Sciences, Tatibandh, GE Road, Raipur, 492099, Chhattisgarh
Approved
INSTITUTIONAL ETHICS COMMITTEE B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL OFFICE OF MEDICAL SUPERINTENDENT CIVIL HOSPITAL Ahmedabad, Gujarat - 380016 India
Approved
Institutional Ethics Committee mysore medical college & Research Institute & associated Hospital, Department of Pathalogy, K R Hospital, Mysore Medical College and Research Institute, Irwin Road, Mysuru Karnataka 570001 India
Institutional Human Ethics Committee,PSG Institute of Medical Sciences & Research, Peelamedu, Coimbatore, Tamil Nadu, India
Approved
Kashyap Memorial eye Hospital Ethics Committee, Purulia Road, Near Dangratoli Chowk,Ranchi,Jharkhand 834001 India
Approved
kenia Medical research and foundation, Institutional Ethics Committee, C -101, Rizvi Nagar, 1st floor Corner of Milan subway S.V, ROad, Santacruz(W).Mumbai-400054
Approved
Magna Care Ethics Committee,Chopda Medicare & Research Centre Pvt.Ltd, Magnum Heart Institute, Canada Corner, Nashik, Maharashtra-422005
Approved
Magna Care Ethics Committee,Chopda Medicare & Research Centre Pvt.Ltd, Magnum Heart Institute, Canada Corner, Nashik, Maharashtra-422005
Approved
Medilink Ethics Committee,1st floor, Medilink hospital research centre, near Shyamal cross road, 132 ft, ring road, Satellite, Ahmedabad-380015
Approved
Shri Ganesh Vinayak Eye Hospital Institutional Ethics Committee, In Front of colours Mall, Near Dhamtari Road, Near Pachpedi Naka, Lalpur, Raipur-492001 Chattisgharh India
Unity Hospital Ethics Committee, Unity Hospital, Janki Park Housing Society, Opp. Raghuvir Business Empire, Aai Mata Road, Parvat Patiya,Surat-395010
Approved
Veracity Independent Ethics Committee, Rock Arkad, shop No-55, Camp Road (Block)Tapovan Road, Amravati- 444602 Maharashtra, India
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: H353||Degeneration of macula and posterior pole,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Eylea
Eylea will be administered at a dose of 2 mg every 4 weeks for initial 12 weeks and thereafter every 8 weeks (last dose at Week 40) as intravitreal injection (study duration will be approximately 52 weeks for each patient which will include: Screening Period up to 28 days and Treatment Period of 48 weeks)
Intervention
Lupin’s Aflibercept
Lupin’s Aflibercept will be administered at a dose of 2 mg every 4 weeks for initial 12 weeks and thereafter every 8 weeks (last dose at Week 40) as intravitreal injection (study duration will be approximately 52 weeks for each patient which will include: Screening Period up to 28 days and Treatment Period of 48 weeks
Inclusion Criteria
Age From
50.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.Ambulatory male or female participants with age ≥50 years who are capable of understanding and giving written informed consent.
2.Active sub-foveal choroidal neovascularization (CNV) lesion secondary to AMD in the study eye.
Active CNV is defined as any leakage detected on fluorescein angiography (FA).
3.BCVA between 20/40 and 20/200 (Snellen equivalent), both inclusive, in the study eye before pupil dilation, using Early treatment diabetic retinopathy study (ETDRS) testing.
4.Females, who are of non-childbearing potential (surgically sterile or menopausal), OR, if of childbearing potential using effective birth control measures during the study and 3 months after the last dose and who are non-pregnant and non-lactating at study entry.
5.Willing and able to undertake all scheduled visits and assessments.
ExclusionCriteria
Details
1. Sub-retinal hemorrhage that comprises >50% of the total lesion or presence of blood with the size of 1 DA (disc areas) or more involving the center of fovea in the study eye as assessed by FA.
2. Scar or fibrosis, making up >50% of total lesion in the study eye as assessed by FA.
3. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye as assessed by FA.
4. Total lesion area ≥12.0 DA in size (including blood, scars, and neovascularization) as assessed by FA in the study eye.
5. Presence of CNV due to other causes, such as pathologic myopia (spherical equivalent of -8.0 diopters or more, or axial length of 25 mm or more), trauma, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye.
6. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
7. Presence of macular hole of any stage in the study eye.
8. Any concurrent macular abnormality other than AMD which could affect central vision or the efficacy assessments in the study eye.
9. Any concurrent ocular/intraocular condition in the study eye which, in the opinion of the Investigator, may interfere with the injection procedure or may confound the evaluation of efficacy or safety.
10. History or clinical evidence of diabetic retinopathy, diabetic macular edema (DME) or any other vascular disease affecting the retina, other than AMD, in either eye.
11. History of any vitreous hemorrhage within 4 weeks prior to randomization in the study eye.
12. Any previous anti-vascular endothelial growth factor (VEGF) treatment in study eye.
13. Any prior ocular treatment/surgery for neovascular AMD in the study eye within 12 months prior to randomization.
14. Prior treatment with aflibercept in the fellow eye.
15. History of previous systemic treatment with Aflibercept or requiring concurrent systemic anti-VEGF treatment during study.
16. History of vitrectomy, scleral buckling (encircling), glaucoma filtration surgery, or pan-retinal photocoagulation in the study eye.
17. Previous treatment with intravitreal steroids (e.g., triamcinolone, anecortave acetate) in the study eye within 3 months prior to randomization.
18. Previous treatment with intravitreal steroid implant in the study eye (like Ozurdex®) or with long-acting systemic steroid within 6 months prior to randomization.
19. Any intraocular or periocular surgery within 3 months prior to randomization in the study eye.
20. Previous radiation therapy in the region of the study eye.
21. Previous participation in any clinical study for treatment of neovascular AMD in study eye or previous participation in any clinical study for treatment of neovascular AMD in fellow eye within last 3 months prior to randomization.
22. Concurrent treatment with an investigational drug or device in the study eye or non-study eye for treatment of disease other than neovascular AMD, or less than 30 days or 5 half-lives (whichever is longer) since ending treatment on another investigational drug or device study(ies) prior to randomization.
23. "Aphakia or pseudophakia with absence of the posterior capsule [unless it occurred as a result of a yttrium aluminum garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens (IOL) implantation] in the study eye.
24. Active intraocular inflammation including scleritis or active or suspected ocular or periocular infection in either eye, within 2 weeks prior to randomization.
25. Clinical evidence of uveitis in either eye.
26. Uncontrolled glaucoma (defined as intraocular pressure [IOP] ≥ 25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
27. Presence or history of scleromalacia in either eye.
28. Known hypersensitivity to aflibercept or any of the components of study medication.
29. History of allergy to the fluorescein sodium for injection in angiography.
30. History or presence of concurrent systemic diseases or dysfunctions requiring significant medical/surgical intervention during study period that might affect interpretation of the results or contraindicates the use of aflibercept or render the subject at high risk for treatment complications based on the Investigator’s judgment such as
Cardiovascular disease (e.g., stroke, myocardial infarction), uncontrolled respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic (e.g., optic neuropathy), metabolic, pulmonary, autoimmune disease or psychiatric disease based on previous history and relevant reports of clinical examination, laboratory tests, or electrocardiogram (ECG) etc.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Mean change in Best Corrected Visual Acuity (BCVA) from baseline to Week 48.
From baseline to Week 48.
Secondary Outcome
Outcome
TimePoints
Efficacy Endpoint: Mean change in BCVA from baseline to Week 16 and Week 32.
From baseline to Week 16 and Week 32.
Safety Endpoint: Incidence of treatment emergent adverse events (TEAEs).
Screening visit to End of study visit.
Immunogenicity Endpoint: Proportion of patients with anti-drug antibodies at pre-dose (Day 1), 4, 8, 16, 32, and 48 weeks.
At pre-dose (Day 1), 4, 8, 16, 32, and 48 weeks.
Target Sample Size
Total Sample Size="498" Sample Size from India="150" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
THIS IS A PHASE III, PROSPECTIVE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, MULTICENTRE STUDY TO COMPARE THE EFFICACY, SAFETY, AND IMMUNOGENICITY OF LUPIN’S AFLIBERCEPT WITH EYLEA® IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION.