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

NCT02611778 | Completed Phase 3 Results DMC

• 1 other identifier: FYB201-C2015-01-P3
• Study Type: interventional
• Target: 712
• Locations: 12 countries
• Sites: 58

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.

Conditions

Age-related Macular Degeneration (AMD)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 8 Weeks

  The primary endpoint was the absolute change from baseline in BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) letters after 2 months (8 weeks) of treatment.

  Baseline and Week 8

Secondary Outcomes (16)

• Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 24 Weeks

  Baseline and Week 24

• Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 48 Weeks

  Baseline and Week 48

• Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 12 Months

  Baseline and 12 Months

• Change in Foveal Centre Point (FCP) Retinal Thickness From Baseline to Week 24

  Baseline and Week 24

• Change in Foveal Centre Point (FCP) Retinal Thickness From Baseline to Week 48

  Baseline and Week 48

Study Arms (2)

FYB201

EXPERIMENTAL

FYB201 is provided as single use vials and will be administered by intra-vitreal injection.

Biological: ranibizumab

Lucentis

ACTIVE COMPARATOR

Lucentis® is provided as single use vials and will be administered by intra-vitreal injection.

Biological: ranibizumab

Interventions

ranibizumab BIOLOGICAL

FYB201; Lucentis

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioeq GmbH: lead

Study Sites (58)

Research Site

Vienna, Austria

Location

Research Site

Brno, Czechia

Location

Research Site

Ostrava, Czechia

Location

Research Site

Pilsen, Czechia

Location

Research Site

Prague, Czechia

Location

Research Site

Zlín, Czechia

Location

Research Site

Dijon, France

Location

Research Site

Lyon, France

Location

Research Site

Nantes, France

Location

Research Site

Paris, France

Location

University of Bonn, Department of Ophthalmology

Bonn, Germany

Location

Research Site

Dresden, Germany

Location

Research Site

Freiburg im Breisgau, Germany

Location

Research Site

Göttingen, Germany

Location

Research Site

Hanover, Germany

Location

Research Site

Leipzig, Germany

Location

Research Site

Mainz, Germany

Location

Research Site

Tübingen, Germany

Location

Research Site

Budapest, Hungary

Location

Research Site

Debrecen, Hungary

Location

Research Site

Nyíregyháza, Hungary

Location

Research Site

Pécs, Hungary

Location

Research Site

Szeged, Hungary

Location

Research Site

Zalaegerszeg, Hungary

Location

Research Site

Beersheba, Israel

Location

Research Site

Haifa, Israel

Location

Research Site

Jerusalem, Israel

Location

Research Site

Kfar Saba, Israel

Location

Research Site

Petah Tikva, Israel

Location

Research Site

Ramat Gan, Israel

Location

Research Site

Rehovot, Israel

Location

Research Site

Tel Aviv, Israel

Location

Research Site

Zrifin, Israel

Location

Research Site

Bologna, Italy

Location

Research Site

Chieti, Italy

Location

Research Site

Milan, Italy

Location

Research Site

Pisa, Italy

Location

Research Site

Roma, Italy

Location

Research Site

Torino, Italy

Location

Research Site

Bydgoszcz, Poland

Location

Research Site

Lodz, Poland

Location

Research Site

Rzeszów, Poland

Location

Research Site

Tarnowskie Góry, Poland

Location

Research Site

Tarnów, Poland

Location

Research Site

Warsaw, Poland

Location

Research Site

Kazan', Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Barcelona, Spain

Location

Research Site

Valencia, Spain

Location

Research Site

Zaragoza, Spain

Location

Research Site

Kyiv, Ukraine

Location

Research Site

Odesa, Ukraine

Location

Research Site

Bradford, United Kingdom

Location

Research Site

Bristol, United Kingdom

Location

Research Site

Camberley, United Kingdom

Location

Research Site

London, United Kingdom

Location

Research Site

Rugby, United Kingdom

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Head of Clinical Development
• Organization: bioeq GmbH

columbus@bioeq.com

+498024463330

Study Officials

• Frank G. Holz, Prof. Dr.

  University of Bonn, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 23, 2015
• Study Start: December 19, 2015
• Primary Completion: December 1, 2017
• Study Completion: June 6, 2018
• Last Updated: September 30, 2021
• Results First Posted: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

UA (2); GB (5); FR (4); PL (6); DE (8); IT (6); RU (3); AU (1); CZ (5); IL (9); ES (3); HU (6)