A study investigating the efficacy, safety, pharmacokinetics, and Immunogenicity of BP05 Versus EU-Approved Lucentis in adults patients with Wet (Neovascular) Age-Related Macular Degeneratio
- Conditions
- Wet (Neovascular) Age-Related Macular DegenerationMedDRA version: 20.0Level: LLTClassification code 10075568Term: Wet age-related macular degenerationSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2021-000590-93-SK
- Lead Sponsor
- CuraTeQ Biologics Private Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 550
1.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.
2.Willing and able to undertake all scheduled visits and assessments as judged by the investigator.
3.Age =50 years at Screening.
4.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.
5.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.
6.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.
7.Best corrected visual acuity of 20/40 to 20/200 in the study eye using ETDRS chart at Screening.
8.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 (as detailed in Appendix 2 [Section 13.2]) from Screening until 3 months after the last IVT injection of the study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 550
-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
-Scarring in the study eye exceeding 50% of total lesion size
-Subfoveal fibrosis or atrophy in the study eye assessed by FA and confirmed by central reading center
-Presence of CNV in either eye due to non-AMD causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia, assessed by FA and confirmed by central reading center
-History or presence of RPE tear or retinal detachment involving the macula in the study eye and fellow eye as assessed by FA and confirmed by central reading center
-History or presence of macular hole in the study eye at Screening, confirmed by central reading center
-History or clinical evidence of diabetic retinopathy (except for mild non-proliferative diabetic retinopathy) or diabetic macular edema in either eye.
-History: of vitrectomy surgery, of trabeculectomy or other filtration surgery, 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.
-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
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<br>•To evaluate the systemic exposure of BP05 versus Lucentis in patients participating in PK evaluation<br>•To evaluate immunogenicity of BP05 versus Lucentis<br>•To evaluate the safety of BP05 versus Lucentis;Primary end point(s): •Change in BCVA letters at Week 8, compared with baseline, in the study eye using the ETDRS chart;Timepoint(s) of evaluation of this end point: at Week 8, compared with baseline
- Secondary Outcome Measures
Name Time Method