Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration (COLUMBUS-AMD)

• Sponsor: Bioeq GmbH
• Information provided by (Responsible Party): Bioeq GmbH

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Age-related Macular Degeneration (AMD)	Biological: ranibizumab	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration
Study Start Date :	February 2016
Actual Primary Completion Date :	December 2017
Actual Study Completion Date :	June 8, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: FYB201; FYB201 is provided as single use vials and will be administered by intra‐vitreal injection.	Biological: ranibizumab
Active Comparator: Lucentis; Lucentis® is provided as single use vials and will be administered by intra‐vitreal injection.	Biological: ranibizumab

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in BCVA by ETDRS letters after 2 months (8 weeks) of treatment [ Time Frame: 2 months ]
   To evaluate and compare functional changes in best corrected visual acuity (BCVA) after 2 months (8 weeks) of treatment with FYB201 or Lucentis, compared to baseline BCVA

Eligibility Criteria

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Ages Eligible for Study:	50 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Locations

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Germany
University of Bonn, Department of Ophthalmology
Bonn, Germany

Sponsors and Collaborators

Bioeq GmbH

Investigators

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Principal Investigator:	Frank G. Holz, Prof. Dr.	University of Bonn, Department of Ophthalmology

More Information

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Responsible Party:	Bioeq GmbH
ClinicalTrials.gov Identifier:	NCT02611778 History of Changes
Other Study ID Numbers:	FYB201-C2015-01-P3
First Posted:	November 23, 2015
Last Update Posted:	January 29, 2019
Last Verified:	January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:

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Ranibizumab; Macular Degeneration; Wet Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases	Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents