Comparison of efficacy and safety of BP05 product and product of Lucentis in patients with Wet Age related Macular Degeneratio
- Conditions
- wet macula degenerationMedDRA version: 20.0Level: LLTClassification code: 10075568Term: Wet age-related macular degeneration Class: 10015919Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- CTIS2023-507459-31-03
- Lead Sponsor
- Curateq Biologics Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 550
Patient or patient’s legally authorized representative is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements., Willing and able to undertake all scheduled visits and assessments as judged by the investigator., Age =50 years at Screening, Patients diagnosed with active* subfoveal CNV lesion secondary to AMD in the study eye. *Active CNV means presence of leakage as evidenced by FA and intra/subretinal fluid as evidenced by OCT, which should be confirmed by the central reading center at Screening, The area of CNV must be =50% of the total lesion area in the study eye and confirmed by the central reading center prior to randomization, Total lesion area =12.0 disc areas in size (including blood, scars, and neovascularizati-on) as assessed by FA in the study eye and confirmed by the central reading center prior to randomization, Best corrected visual acuity of 20/40 to 20/200 in the study eye using ETDRS chart at Screening, Nonchildbearing potential female (eg, permanently sterilized, postmenopausal [defined as 12 months with no menses without an alternative medical cause prior to Screening]), OR Childbearing potential female patients or male patients with their (respectively male or female) partners who agree to use at least 2 forms of appropriate contraception method that can achieve a failure rate of less than 1% per year from Screening until 3 months after the last IVT injection of the study drug.
Sub- or intraretinal hemorrhage involving the fovea in the study eye of 50% or more of the total lesion area assessed by FA and confirmed by central reading center., History of submacular surgery or other surgical intervention for AMD in the study eye, Any other intraocular surgery (including cataract surgery) or periocular surgery in the study eye within 90 days prior to randomization, except for lid surgery, which may not have taken place within 30 days prior to randomization, Any previous IVT anti-VEGF treatment (eg, bevacizumab, aflibercept, ranibizumab) in either eye, Any previous systemic anti-VEGF treatment, within 90 days prior to randomization, and such treatment will not be allowed during the study period., Any systemic treatment or therapy (including prescribed herbal medication) to treat wAMD within 30 days prior to randomization, and such treatment or therapy will not be allowed during the study period. However, dietary supplements, vitamins, or minerals will be allowed., Any IVT injection of corticosteroid (eg, triamcinolone acetonide) or IVT corticosteroid implant in the study eye within 180 days prior to randomization, and such treatment will not be allowed during the study period, Topical ocular corticosteroids administered for =30 consecutive days in the study eye within 90 days prior to Screening, Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia. For patients who have undergone previous refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye must not exceed 8 diopters of myopia, Aphakia or absence of the posterior capsule in the study eye, unless it occurred as a result of a yttrium aluminium garnet posterior capsulotomy in association with prior posterior chamber intraocular lens implantation, Presence of scleromalacia in either eye, Scarring in the study eye exceeding 50% of total lesion size., Current vitreous hemorrhage in the study eye, Active or recent (within 28 days prior to randomization) intraocular, extraocular, and periocular inflammation or infection in either eye, History of idiopathic or autoimmune-associated uveitis in either eye, Corneal transplant in the study eye, Presence of advanced glaucoma or optic neuropathy that involve or threaten the central visual field in the study eye, Uncontrolled ocular hypertension in the study eye, defined as IOP =30 mmHg despite treatment with antiglaucoma medication, History of allergy to the fluorescein sodium for injection in angiography, Contraindication for any of the excipients in BP05 or Lucentis (active or suspected ocular or periocular infection, or active severe intraocular inflammation), Reasonable suspicion of a disease or condition that might render the patient at high risk of treatment complications or affect interpretation of the study results (as judged by the investigator), Previous participation in clinical studies of ocular investigational products to treat wAMD in either eye or systemic investigational products to treat wAMD, and such participation will not be allowed during the study period, Subfoveal fibrosis or atrophy in the study eye assessed by FA and confirmed by central reading center., Previous participation in any studies of ocular or systemic investigational products (excluding dietary supplements, vitamins, and minerals) to treat ocular or systemic disease other than wAMD within 90 days prior to randomization, and such participation wi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of a biosimilar candidate BP05 versus Lucentis in patients with wAMD;Secondary Objective: To evaluate the efficacy of BP05 versus Lucentis in patients with wAMD based on CFT, area of CNV, and leakage from CNV lesion, To evaluate the safety of BP05 versus Lucentis, To evaluate immunogenicity of BP05 versus Lucentis, To evaluate the systemic exposure of BP05 versus Lucentis in patients participating in PK evaluation;Primary end point(s): Change in BCVA letters at Week 8, compared with baseline, in the study eye using the ETDRS chart
- Secondary Outcome Measures
Name Time Method