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Comparison of efficacy and safety of BP05 product and product of Lucentis in patients with Wet Age related Macular Degeneration
EU CTIS ID: 2023-507459-31-03
What this study is testing
To evaluate the efficacy of a biosimilar candidate BP05 versus Lucentis in patients with wAMD
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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 will not be allowed during the study period even if the investigational product is dietary supplements, vitamins, or minerals
- 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
- 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
- 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.
- 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
- Stroke, transient ischemic attacks, or myocardial infarction within 90 days prior to randomization
- History of recurrent significant infections and/or current treatment for active systemic infection.
- Pharmacokinetic subgroup only: contraindication for additional blood sampling (as judged by the investigator).
- 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 in the study eye.
- History of trabeculectomy or other filtration surgery in the study eye
The study team makes the final eligibility decision.
Where it's taking place
- India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.