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

Completed · Phase 3

Conditions studied: Macular Degeneration

In brief

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).

Key facts

Study ID

NCT03805100

Run by

Xbrane Biopharma AB

People needed

582

Starts

2019-04-19

Expected to finish

2021-11-11

Last updated by the study team

2023-11-13

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Retina and Vitreous Consultants — Phoenix, Arizona, United States
• Retina Centers P.C — Tucson, Arizona, United States
• Win Retina — Arcadia, California, United States
• The Retina Partners — Encino, California, United States
• Mark B. Kislinger MD Inc. — Glendora, California, United States
• Retina Consultants Medical Group Inc. — Sacramento, California, United States
• Colorado Retina Associates — Golden, Colorado, United States
• Fort Lauderdale Eye Institute — Fort Lauderdale, Florida, United States
• Sarasota Retina Institute — Sarasota, Florida, United States
• Center for Retina and Macular Disease — Winter Haven, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Georgia Retina — Marietta, Georgia, United States
• Gailey Eye Clinic — Bloomington, Illinois, United States
• Sabates Eye Centers — Leawood, Kansas, United States
• Retina Vitreous Surgeons of Central New York PC — New York, New York, United States
• Retina Associates of Western New York — Rochester, New York, United States
• Charleston Neuroscience Institute — Ladson, South Carolina, United States
• Black Hills Regional Eye Institute — Rapid City, South Dakota, United States
• Retina Research Institute of Texas — Abilene, Texas, United States
• Austin Retina Associates — Austin, Texas, United States
• Houston Eye Associates — Houston, Texas, United States
• Retina Consultants of Houston — Houston, Texas, United States
• Medical Center Ophthalmology Associates — San Antonio, Texas, United States
• Retina Consultants of Houston — The Woodlands, Texas, United States
• Retinal Research Institute, LLC — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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