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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
705

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Fakultní Nemocnice Královské 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 Oktatókórház
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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