Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration
Condition: Age-related Macular Degeneration (AMD)
MeSH terms: Macular Degeneration
Intervention: ranibizumab
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 712.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy and safety of the biosimilar
      ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular
      degeneration.
    

Eligibility criteria:

        Inclusion criteria:

          -  Age ≥ 50 years of either gender

          -  Signed informed consent form must be obtained before any study-related procedure is
             performed

          -  Willingness and ability to undertake all scheduled visits and assessments

          -  Women must be postmenopausal or surgically sterile

          -  Newly diagnosed, angiographically documented, primary active Choroidal
             Neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD)

          -  Sufficiently clear ocular media and adequate pupillary dilation to permit good quality
             ocular imaging

          -  Best-corrected Visual Acuity (BCVA) in the study eye, determined by standardized Early
             Treatment Diabetic Retinopathy Study (ETDRS) testing, between 20/32 (0.63) and 20/100
             (0.2) Snellen equivalent

          -  Foveal Center Point (FCP) retinal thickness in at Screening ≥ 350 µm

          -  BCVA in the fellow eye, determined by standardized ETDRS testing, at least 20/100
             (0.2) Snellen equivalent

        Exclusion criteria:

          -  Employees of clinical study sites, individuals directly involved with the conduct of
             the study or immediate family members thereof, prisoners, and persons who are legally
             institutionalized

          -  Any previous treatment with intravitreal (IVT) anti-vascular endothelial growth factor
             (VEGF) agent in either eye

          -  History of vitrectomy, macular surgery or other surgical intervention for AMD in the
             study eye

          -  History of IVT or periocular injections of corticosteroids or device implantation
             within six months prior to Screening in the study eye

          -  Prior treatment with verteporfin (photodynamic therapy), transpupillary thermotherapy,
             radiation therapy, or retinal laser treatment (e.g. focal laser photocoagulation) in
             the study eye

          -  Topical ocular corticosteroids administered for at least 30 consecutive days within
             three months prior to Screening

          -  Any other intraocular surgery (including cataract surgery) in the study eye within
             three months prior to Screening

          -  Sub- or intra-retinal hemorrhage that comprises more than 50% of the entire lesion in
             the study eye

          -  Fibrosis or atrophy involving the center of the fovea or influencing central visual
             function in the study eye

          -  CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or
             pathologic myopia

          -  Retinal pigment epithelial tear involving the macula in the study eye

          -  History of full-thickness macular hole in the study eye

          -  History of retinal detachment in the study eye

          -  Current vitreous hemorrhage in the study eye

          -  Spherical equivalent of the refractive error in the study eye demonstrating more than
             8 diopters of myopia

          -  For patients who have undergone prior refractive or cataract surgery in the study eye,
             the preoperative refractive error in the study eye cannot exceed 8 diopters of myopia

          -  History of corneal transplant in the study eye

          -  Aphakia in the study eye. Absence of an intact posterior capsule is allowed if it
             occurred as a result of Yttrium-Aluminium-Garnet (YAG) laser posterior capsulotomy in
             association with prior posterior chamber intraocular lens (IOL) implantation

          -  Active or recent (within 4 weeks) intraocular inflammation of clinical significance in
             the study eye such as active infections of the anterior segment (excluding mild
             blepharitis) including conjunctivitis, keratitis, scleritis, uveitis or
             endophthalmitis

          -  Uncontrolled hypertension or glaucoma in the study eye (defined as intraocular
             pressure (IOP) ≥30 mm Hg, despite treatment with anti-glaucomatous medication)

          -  Ocular disorders in the study eye (i.e. retinal detachment, pre-retinal membrane of
             the macula or cataract with significant impact on visual acuity) at the time of
             enrollment that may confound interpretation of study results and compromise visual
             acuity

          -  Any concurrent intraocular condition in the study eye (e.g. glaucoma, cataract or
             diabetic retinopathy) that, in the opinion of the Investigator, would either require
             surgical intervention during the study to prevent or treat visual loss that might
             result from that condition or affect interpretation of study results.

          -  Use of other investigational drugs (excluding vitamins, minerals) within 30 days or 5
             half-lives from Screening, whichever is longer

          -  Any type of advanced, severe or unstable disease, including any medical condition
             (controlled or uncontrolled) that could be expected to progress, recur, or change to
             such an extent that it may bias the assessment of the clinical status of the patient
             to a significant degree or put the patient at special risk

          -  Stroke or myocardial infarction within three months prior to Screening

          -  Presence of uncontrolled systolic blood pressure > 160 mmHg or uncontrolled diastolic
             blood pressure > 100 mmHg

          -  Known hypersensitivity to the investigational drug (ranibizumab or any component of
             the ranibizumab formulation) or to drugs of similar chemical class or to fluorescein
             or any other component of fluorescein formulation

          -  Current or planned use of systemic medications known to be toxic to the lens, retina
             or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine (Plaquenil®),
             tamoxifen, phenothiazines and ethambutol

          -  History of recurrent significant infections and/or current treatment for active
             systemic infection

          -  Pregnancy or lactation

          -  Systemic treatment with high doses of corticosteroids (administration of >10 mg/day of
             prednisolone equivalent) during the last six months prior to Screening

          -  Inability to comply with study or follow-up procedures

          -  Any diagnosis and/or signs of nAMD requiring treatment with an IVT anti-VEGF agent
             (e.g. aflibercept, bevacizumab, ranibizumab) within the screening period or at study
             treatment initiation (Visit 1) in the fellow eye