Clinical trial to Compare the Efficacy, Safety, and Immunogenicity of Lupinâ€™s Aflibercept with EyleaÂ® in Patients with Neovascular Age-Related Macular Degeneration

Phase 3

Active, not recruiting

Conditions: Degeneration of macula and posterior pole,

Registration Number: CTRI/2023/03/050806

Lead Sponsor: Ms Lupin Limited

Brief Summary: THIS IS A PHASE III, PROSPECTIVE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, MULTICENTRE STUDY TO COMPARE THE EFFICACY, SAFETY, AND IMMUNOGENICITY OF LUPINâ€™S AFLIBERCEPT WITH EYLEAÂ® IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 498

Inclusion Criteria

1.Ambulatory male or female participants with age â‰¥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.

Exclusion Criteria

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 â‰¥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.
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 OzurdexÂ®) 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] â‰¥ 25 mmHg despite treatment with anti-glaucoma medication) in the study 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 Investigatorâ€™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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in Best Corrected Visual Acuity (BCVA) from baseline to Week 48.	From baseline to Week 48.

Secondary Outcome Measures

Name	Time	Method
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).
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.

Trial Locations

Locations (32): Agrawal Hospital
🇮🇳
Jaipur, RAJASTHAN, India
AIIMS Raipur
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Raipur, CHHATTISGARH, India
Akash Health Care super speciality Hospital
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Delhi, DELHI, India
Ambade Eye Hospital
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Nagpur, MAHARASHTRA, India
Amrita Institute of Medical Sciences & Research Centre
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Ernakulam, KERALA, India
Aravind Eye Hospital
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Coimbatore, TAMIL NADU, India
Aravind Eye Hospital and Post Graduate Institute of Ophthalmology
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Coimbatore, TAMIL NADU, India
Career institute of Medical Science and Hospital,
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Lucknow, UTTAR PRADESH, India
Chopda Medicare & Research Centre Pvt. Ltd., Magnum Heart Institute
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Nashik, MAHARASHTRA, India
Datta Meghe Institute of Higher Education & Research,
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Wardha, MAHARASHTRA, India
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Agrawal Hospital
🇮🇳Jaipur, RAJASTHAN, India
Dr Vishal Agrawal
Principal investigator
9024472330
drvishalsms@gmail.com