A Phase 3 Study to Compare Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Test Product (BP05) Versus Reference Product (Lucentis®) in Patients with Wet (Neovascular) Age-Related Macular Degeneration.

Phase 3

Recruiting

• Conditions: Degeneration of macula and posterior pole,

• Registration Number: CTRI/2022/01/039264
• Lead Sponsor: CuraTeQ Biologics Private Ltd

Brief Summary

This is a Phase 3, multicenter, randomized, double-blind, multi-dose, parallel group, active comparator study comparing the efficacy, safety, PK, and immunogenicity profiles of BP05 with the comparator marketed product, Lucentis, in patients with wAMD. Efforts will be made to include approximately 30% of the patients with light iris color to meet the FDA and EU regulations A total of 550 patients with wAMD will be randomized in this study in approximately 65 sites across the globe. Efforts will be made to recruit approximately 50% of the patients from India and 50% of the patients from Europe and Russia. Each patient will be assigned a screening number and evaluated for the inclusion and exclusion criteria as part of the screening procedures. Patients who meet all of the inclusion criteria and none of the exclusion criteria will be randomly assigned and treated on Day 1. At this visit, the patient will be randomly assigned in 1:1 ratio using IWRS to one of the following cohorts :Cohort 1: BP05 (275 patients with wAMD) Cohort 2: Lucentis (275 patients with wAMD) The study is designed to compare 2 preparations of ranibizumab (BP05 or Lucentis) in patients with wAMD when administered as a single IVT injection of 0.05 mL (0.5 mg) into the study eye on Day 1 of 4-week cycle. Randomization will be stratified by baseline BCVA scores, baseline CNV classification, and country. Patients will be treated with either BP05 or Lucentis every 4 weeks until Week 48 as detailed in the Schedule of Events. Pharmacokinetic evaluation will be performed in a subset of patients who provided consent (20 patients in each treatment group). This study includes a screening duration up to 2 weeks, study treatment duration up to 48 weeks, and the follow-up duration up to 4 weeks; thus, the total duration of study participation is approximately up to 54 weeks.All patients will be assessed once every 4 weeks as detailed in the Schedule of Events. The EOT visit will be scheduled at Week 48 for those who receive all the scheduled injections. The EOS visit will occur at Week 52, which is 4 weeks after the EOT visit for patients who receive all the scheduled injections. The end of the study is defined as the date of the last visit of the last patient in the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

• 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 neovascularization) 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 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.

Exclusion Criteria

• 1.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.
• 2.Scarring in the study eye exceeding 50% of total lesion size.
• 3.Subfoveal fibrosis or atrophy in the study eye assessed by FA and confirmed by central reading center.
• 4.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.
• 5.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.
• 7.History or clinical evidence of diabetic retinopathy (except for mild non-proliferative diabetic retinopathy) or diabetic macular edema in either eye.
• 8.History of vitrectomy surgery in the study eye.
• 9.History of trabeculectomy or other filtration surgery in the study eye.
• 10.History of submacular surgery or other surgical intervention for AMD in the study eye.
• 11.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 12.Any previous IVT anti-VEGF treatment (eg, bevacizumab, aflibercept, ranibizumab) in either eye.
• 13.Any previous systemic anti-VEGF treatment, within 90 days prior to randomization, and such treatment will not be allowed during the study period.
• 14.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.
• 15.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.
• 16.Topical ocular corticosteroids administered for ≥30 consecutive days in the study eye within 90 days prior to Screening.
• 17.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.
• 18.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.
• 19.Presence of scleromalacia in either eye.
• 20.Current vitreous hemorrhage in the study eye.
• 21.Active or recent (within 28 days prior to randomization) intraocular, extraocular, and periocular inflammation or infection in either eye.
• 22.History of idiopathic or autoimmune-associated uveitis in either eye.
• 23.Corneal transplant in the study eye.
• 24.Presence of advanced glaucoma or optic neuropathy that involve or threaten the central visual field in the study eye.
• 25.Uncontrolled ocular hypertension in the study eye, defined as IOP ≥30 mmHg despite treatment with antiglaucoma medication 26.History of allergy to the fluorescein sodium for injection in angiography.
• 27.Contraindication for any of the excipients in BP05 or Lucentis (active or suspected ocular or periocular infection, or active severe intraocular inflammation).
• 28.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).
• 29.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.
• 30.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 will not be allowed during the study period even if the investigational product is dietary supplements, vitamins, or minerals.
• 31.Any concurrent ocular condition in the study eye, which in the opinion of the investigator, could either increase the risk to the patient safety or which otherwise may interfere with evaluation of efficacy or safety including, but not limited to ocular media opacities such as corneal opacity or cataract that do not allow proper fundus visualization and fundus imaging, and ocular surface abnormalities, which prevent applanation tonometry during the study period after randomization.
• 32.History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of the study drug in the opinion of the investigator.
• 33.Pregnant or lactating women.
• A urine pregnancy test must be required for women of childbearing potential at Screening and must agree to pregnancy prevention throughout the duration of the study.
• 34.Employees of investigational sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of a biosimilar candidate BP05 versus Lucentis in patients with wAMD	Week 48 and Week 52

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of BP05 versus Lucentis in patients with wAMD based on CFT, area of CNV, and leakage from CNV lesion	Change in BCVA letters over the course of the study compared with baseline in the study eye using the ETDRS chart
To evaluate the systemic exposure of BP05 versus Lucentis in patients participating in PK evaluation	Number of patients without intra/subretinal fluid at Week 24 and Week 52 in the study eye

Trial Locations

Locations (32)

Advanced Eye Centre,PGIMER; 🇮🇳 Chandigarh, CHANDIGARH, India

Agrawal Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

AIIMS Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

Amrita Institute of Medical Sciences and Research Center; 🇮🇳 Ernakulam, KERALA, India

Anjani Eye Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Aravind Eye Hospital & Postgraduate Institute of Ophthalmology; 🇮🇳 Coimbatore, TAMIL NADU, India

Chopda Medicare & Research Centre Pvt. Ltd.; 🇮🇳 Nashik, MAHARASHTRA, India

Disha Eye Hospitals Pvt Ltd; 🇮🇳 Parganas, WEST BENGAL, India

Dr Agarwals Eye Hospital Ltd; 🇮🇳 Chennai, TAMIL NADU, India

Dr. Chakne eye and children hospital; 🇮🇳 Pune, MAHARASHTRA, India

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Advanced Eye Centre,PGIMER

🇮🇳Chandigarh, CHANDIGARH, India

Dr Simar Rajan Singh

Principal investigator

9914427851

simarrajansingh@gmail.com