A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)

April 29, 2021 updated by: Samsung Bioepis Co., Ltd.

A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity Between SB11 and Lucentis® in Subjects With Neovascular Age-related Macular Degeneration

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in subjects with neovascular AMD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will be randomised in a 1:1 ratio to receive either SB11 or Lucentis® (administered via intravitreal (ITV) 0.5 mg every 4 weeks). Investigational Products (IP) (SB11 or Lucentis®) will be administered up to Week 48, and the last assessment will be done at Week 52.

Study Type

Interventional

Enrollment (Actual)

705

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia
        • University Hospital Brno
      • Hradec Králové, Czechia
        • University hospital Hradec Králové
      • Olomouc, Czechia
        • University Hospital Olomouc
      • Ostrava, Czechia
        • University Hopsital Ostrava
      • Praha 10, Czechia
        • Fakultni nemocnice Kralovske Vinohrady
      • Praha 5, Czechia
        • Axon Clinical s.r.o.
  • Germany
      • Berlin, Germany
        • Charité
      • Bonn, Germany
        • Universitaetsklinikum Bonn
      • Chemnitz, Germany
        • Klinikum Chemnitz gGmbH
      • Duesseldorf, Germany
        • Uni Düsseldorf
      • Freiburg, Germany
        • University Medical Center, Freiburg
      • Goettigen, Germany
        • Uni Göttingen
      • Muenchen, Germany
        • TU Munich
      • Siegburg, Germany
        • MVZ ADTC Siegburg GmbH
      • Tuebingen, Germany
        • University of Tuebingen STZ eyetrial at the Department of Ophthalmology
    • Munster
      • Münster, Munster, Germany
        • Augenärzte am St. Franziskus-Hospital Münster
  • Hungary
      • Budapest, Hungary
        • Magyar Honvédség Egészségügyi Központ
      • Budapest, Hungary
        • Jahn Ferenc Del-pesti Korhaz es Rendelointezet
      • Budapest, Hungary
        • Bajcsy-Zsilinszky Korhaz es Rendelointezet
      • Budapest, Hungary
        • Budapest Retina Associates Ltd.
      • Budapest, Hungary
        • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
      • Budapest, Hungary
        • Semmelweis Egyetem Szemeszeti Klinika
      • Debrecen, Hungary
        • Debreceni Egyetem Klinikai Kozpont, Szemklinika
      • Szeged, Hungary
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
      • Szombathely, Hungary
        • Markusovszky Egyetemi Oktatokorhaz
    • Pecs
      • Pécs, Pecs, Hungary
        • Ganglion Orvosi Központ
  • India
      • Ahmedabad, India
        • Medilink Hospital
      • Chandigarh, India
        • PGIMER
      • Chennai, India
        • Shankara Netralaya
      • Coimbatore, India
        • Aravind Eye Hospital
      • Mumbai, India
        • Shroff Eye Hospital
      • Trivandrum, India
        • Regional Institute of Opthalmology
  • Korea, Republic of
      • Busan, Korea, Republic of
        • Pusan National University Hospital
      • Daegu, Korea, Republic of
        • Yeungnam University Hospital
      • Seongnam-si, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • The Catholic University of Korea, Seoul ST. Mary's Hospital
  • Poland
      • Bydgoszcz, Poland
        • Oftalmika ul. Modrzewiowa 15 85-631 Bydgoszcz
      • Katowice, Poland
        • Specjalistyczna Praktyka Lekarska Prof. E. Wylęgała
      • Kraków, Poland
        • Centrum Medyczne UNO-MED.
      • Olsztyn, Poland
        • Centrum Diagnostyki i Mikrochirurgii Oka LENS
    • Tarnow
      • Tarnów, Tarnow, Poland
        • Centrum Medyczne UNO-MED.
    • Walbrzych
      • Wałbrzych, Walbrzych, Poland
        • Szpital Specjalistyczny im Sokołowskiego Oddzial Okulistyczny
    • Wroclaw
      • Wrocław, Wroclaw, Poland
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego, Klinika Okulistyki
  • Russian Federation
      • Kazan, Russian Federation
        • "State Autonomous Iinstitution of Healthcare "Republican clinical ophthalmological hospital of MoH of Republic of Tatarstan"
      • Moscow, Russian Federation
        • Deputy Director of The S.N.Fyodorov Eye Microsurgery State Institution Complex
      • Moscow, Russian Federation
        • Federal State Budget Scientific Institution "Scientific Research Institute of Eye Diseases"
      • Novosibirsk, Russian Federation
        • Federal State Autonomous Institution "Intersectoral research and technical complex "Eye Microsurgery" named after acad. S.N. Fyodorov" of Ministry of Health of Russian Federation
      • Saint Petersburg, Russian Federation
        • Federal State Educational Institution of High Professional Education "1st Saint-Petersburg State Medical University n.a. academic I.P. Pavlov" of Ministry of Healthcare of Russian Federation
      • Samara, Russian Federation
        • SBEI HPE "Samara State Medical University" of the MoH of the RF
  • United Kingdom
      • Belfast, United Kingdom
        • Queens University Belfast
      • Bristol, United Kingdom
        • Bristol Eye Hospital
      • Frimley, United Kingdom
        • Frimley Park Hospital
      • London, United Kingdom
        • Moorfields Eye Hospital
  • United States
    • California
      • Poway, California, United States, 92064
        • Retina Consultants San Diego
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Retina Consultants
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Retina Consultants Of Hawaii
    • Indiana
      • Indianapolis, Indiana, United States, 46280
        • Raj K. Maturi, MD, PC
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Retina Center of New Jersey, LLC
      • Toms River, New Jersey, United States, 08755-8063
        • NJ Retina
    • New York
      • Great Neck, New York, United States, 11021
        • LIVR
      • Hauppauge, New York, United States, 11788
        • Long Island Vitreoretinal Consultants
      • Rochester, New York, United States, 14620
        • Retina Associates of Western NY
      • Syracuse, New York, United States, 13224
        • Retina Vitreous Surgeons fo Central NY, PC
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Retina Associates of Cleveland
    • South Carolina
      • Ladson, South Carolina, United States, 29414
        • Charleston Neuroscience Institute
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Austin, Texas, United States, 78705
        • Austin Restina Associates
      • Conroe, Texas, United States, 77030
        • Retina Consultants of Houston
      • Houston, Texas, United States, 77030
        • Retina Consultants of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 50 years
  2. Newly diagnosed, active subfoveal choroid neovascularisation (CNV) lesion secondary to AMD in the study eye
  3. BCVA of 20/40 to 20/200 in the study eye
  4. Written informed consent form

Exclusion Criteria:

  1. Any previous ITV anti-vascular endothelial growth factor (anti-VEGF) treatment to treat neovascular AMD in either eye
  2. Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia
  3. Any concurrent macular abnormality other than AMD in the study eye

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SB11 (Proposed ranibizumab biosimilar)
Drug: SB11 (Proposed ranibizumab biosimilar)
SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
ACTIVE_COMPARATOR: Lucentis (ranibizumab)
Drug: Lucentis (ranibizumab)
Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Time Frame: Baseline and Week 8
The VA was assessed using original series ETDRS charts or 2702 series number charts.
Baseline and Week 8
Change From Baseline in Central Subfield Thickness (CST)
Time Frame: Baseline and Week 4
The average retinal thickness in the central 1-mm area in the ETDRS grid (CST) was evaluated using (Optical Coherence Tomography) OCT
Baseline and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Bioepis Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 14, 2018

Primary Completion (ACTUAL)

May 24, 2019

Study Completion (ACTUAL)

December 9, 2019

Study Registration Dates

First Submitted

May 10, 2017

First Submitted That Met QC Criteria

May 11, 2017

First Posted (ACTUAL)

May 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 21, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB11-G31-AMD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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