Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis in Patients With nAMD

  • STATUS
    Recruiting
  • End date
    Dec 24, 2021
  • participants needed
    580
  • sponsor
    Xbrane Biopharma AB
Updated on 24 January 2021
angiography
vegf
be 50
bevacizumab
vascular endothelial growth factor
ranibizumab
neovascularization
lucentis
corrected visual acuity
fluorescein angiography
optical coherence tomography
age-related macular degeneration

Summary

The objectives of the study are to demonstrate the equivalence of Xlucane to Lucentis in treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).

Description

This is a phase III multicenter, double-masked, randomized, parallel group study in subjects with wAMD. Approximately 580 subjects will be enrolled and randomized in a 1:1 ratio to receive either Lucentis or the investigational product, Xlucane in the study eye once every 4 weeks for 52 weeks. The study eye will be defined as the eye meeting the enrollment criteria. The assigned study drug will be administered as an ophthalmic intravitreal (IVT) injection. A subgroup of 60 subjects at a select number of participating sites will be sequentially asked to participate in an evaluation of PK.

Details
Condition age-related macular degeneration, Maculopathy, Macular Degeneration
Treatment ranibizumab
Clinical Study IdentifierNCT03805100
SponsorXbrane Biopharma AB
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written and signed informed consent form obtained at screening, before any study-related procedures
Willingness and ability to undertake all scheduled visits and assessments as judged by the investigator
Newly diagnosed, active subfoveal Choroidal Neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD) in the study eye. Note: Active CNV indicates the presence of leakage as evidenced by Fluorescein Angiography (FA) and intra- or subretinal fluid as evidenced by Optical Coherence Tomography (OCT) which must be confirmed by the central reading center during Screening
The area of CNV must be 50% of the total lesion area in the study eye, and
Total lesion area 9.0 Disc Areas (DA) in size (including blood, scars and neovascularization) as assessed by FA in the study eye
Best Corrected Visual Acuity (BCVA) of 73 and 49 ETDRS letter score in the study eye, using ETDRS chart (20/40 to 20/100 Snellen equivalent) at Screening
Fellow eye should not be expected to need any anti-VEGF treatment for the duration of study participation
Age 50 years at screening
Male and female subjects of childbearing potential must be willing to completely abstain or agree to use an appropriate method of contraception, from the time of signing informed consent and for the duration of study participation through 3 months, following the last dose of study drug

Exclusion Criteria

Any previous intervention including pharmacological treatment, laser and/or surgery for wAMD in either eye; (Exception: Vitamin supplementation for AMD prevention)
Any previous vitreoretinal surgery in the study eye for any cause
Any previous IVT treatment including any anti-VEGF medications, steroids and/or any other investigational medication in either eye
The use of long-acting steroids, either systemic or intraocular in any eye, in the 18 months before planned initiation of study treatment. (Note: Iluvien [fluocinolone acetonide intravitreal], current or planned implantation during the study, is prohibited.)
Subfoveal fibrosis, atrophy or scarring extending > 50% of total lesion area, in the study eye as assessed by the investigator at screening and confirmed by the central reading center prior to randomization
Choroidal neovascularization in either eye due to non-AMD causes (eg, DME, RVO, ocular histoplasmosis or trauma, etc.) as assessed by FA and confirmed by central reading center
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
Infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye
Unmedicated intraocular pressure (IOP) 30 mmHg at Screening in either eye
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
Corneal transplant or corneal dystrophy in the study eye
History of rhegmatogenous retinal detachment in the study eye
History of macular hole in the study eye
Retinal pigment epithelial tear or rip, involving the macula in the study eye as assessed by FA and confirmed by the central reading center
Current vitreous hemorrhage in the study eye
Subretinal hemorrhage that is 50% of the total lesion area in the study eye, or if the subretinal hemorrhage involves the fovea is 1 or more DA ( 2.54 mm2) in size in the study eye, as assessed by FA and confirmed by the central reading center
Other intraocular surgery (including cataract surgery) in the study eye within the 3 months prior to baseline. The yttrium aluminum garnet [YAG] posterior capsulotomy is allowed not later than 4 weeks prior to screening
Any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could require treatment during the study period to prevent or treat loss of visual acuity
Significant media opacities (including cataract) in the study eye interfering with BCVA assessment or fundus imaging (FA/FP/OCT)
Aphakia or absence of the posterior capsule in the study eye, unless it occurred as a result of a YAG posterior capsulotomy in association with prior posterior chamber intraocular lens implantation
Presence of advanced glaucoma or optic neuropathy that involve(s) or threaten(s) the central visual field in the study eye (as judged by the investigator)
History of glaucoma filtering surgery or argon laser trabeculoplasty in the study eye (Exception: Laser iridotomy and selective laser trabeculoplasty are allowed)
Uncontrolled ocular glaucoma or hypertension in the study eye, defined as IOP 25 mmHg despite treatment with anti-glaucoma medication
Any previous systemic anti-VEGF treatment (eg, bevacizumab)
Contraindication for Lucentis (hypersensitivity to ranibizumab or to any of the study treatment excipients)
Current treatment for active systemic infection
Females who are pregnant, nursing, planning a pregnancy during the study, or of childbearing potential and not using a reliable method of contraception and/or not willing to use a reliable method of contraception during their participation in the study
Participation in another clinical trial within the previous 3 months or any other clinical trial of anti-angiogenic drugs
Reasonable suspicion of other disease or condition that might render the subject at a high risk of treatment complications or otherwise confound interpretation of the study results (as judged by the investigator)
PK subgroup only: Contraindication for additional blood sampling (as judged by the investigator)
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