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Neovascular Age-related Macular DegenerationPhase 2NCT06176963

A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO

A Phase 2 study testing SB11 PFS in people with Neovascular Age-related Macular Degeneration and Macular Edema, run by Samsung Bioepis Co., Ltd. at 3 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB11 PFS with intravitreal injection to subjects with nAMD or Macular Oedema… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SB11 PFS
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
3 sitesPoland
Study dates
21 Nov 2023to 12 Dec 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Neovascular AMD or macular oedema secondary to RVO in the study eye
  • Study eye deemed to be indicated for ranibizumab ITV therapy at the discretion of the ophthalmologist (e.g., retina specialist)
  • Aged 18 years and older at the time of signing the informed consent form (ICF)
  • Written ICF must be obtained from the subject prior to any study-related procedure (if the subject cannot read ICF, an impartial witness will be present during the entire informed consent discussion)
  • Willingness and ability to undertake all scheduled visits and assessments

Who cannot join

  • Best Corrected Visual Acuity (BCVA) of the level of Finger Count or worse [i.e., 0 letter reading using Early Treatment Diabetic Retinopathy Study (ETDRS) chart] in one or both eyes at Screening or at Day 1
  • History of and/or current intraocular inflammation (any grading from trace and greater is excluded), including non-infectious uveitis, infectious uveitis, or scleritis, or history of sterile inflammatory reaction after the past ITV injections with any agent in either eye
  • Active or suspected infectious disease, or active disorder that preclude safe use of IP at the discretion of the Investigator, in either eye or adnexa of either eye at Screening or at Day 1
  • History of excessive bleeding and recurrent haemorrhages, including any prior excessive intraocular bleeding or haemorrhages after ITV injection or intraocular procedures in either eye
  • History of massive subconjunctival haemorrhages of concern reported by the subject after an ITV injection in either eye
  • Uncontrolled intraocular pressure (IOP) greater than (≥) 25 mmHg in the study eye at Screening or at Day 1
Show all 18Show fewer
  • Treatment with any ITV injection within the 30 days prior to Day 1 in the study eye
  • Any invasive ocular surgery including retinal detachment surgery, long-acting ocular therapeutic agent/implant including corticosteroid, or ocular drug release device implant (approved or investigational) in the study eye within 90 days prior to Day 1 or planned intraocular surgery within next 28 days after Day 1
  • Ocular laser surgery in study eye at any time within the past 30 days prior to Day 1
  • Treatment with any ocular IP in either eye within 90 days prior to Day 1
  • Treatment with systemic anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days prior to Day 1
  • Receipt of any systemic (non-ocular) IP within 180 days prior to Day 1
  • Use of therapies that are known to be toxic to ocular tissue within the 180 days prior to Day 1, including, but not limited to, deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin, or ethambutol
  • Known ocular or non-ocular conditions that per the ophthalmologist (e.g., retina specialist) represent a contraindication to ranibizumab use in the patient or may represent an unwarranted patient risk
  • Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg while sitting confirmed after repeated measurement) at Screening or Day 1
  • Current systemic infectious disease or therapy for active infectious disease
  • Pregnant or lactating women at Screening or at Day 1
  • Note: Other Protocol Defined Inclusion/Exclusion Criteria Apply

Trial locations and contacts

3 sites in 1 country.

Poland3 sites

  • SB Investigational Site

    Katowice

  • SB Investigational Site

    Krakow

  • SB Investigational Site

    Olsztyn

Other trials in Poland

About this study

Official title: An Open-label, Single Group, Single-dose Clinical Study to Evaluate the Usability of the Pre-filled Syringe of SB11 in Subjects With Neovascular Age-Related Macular Degeneration or Macular Oedema Secondary to Retinal Vein Occlusion

This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB11 PFS with intravitreal injection to subjects with nAMD or Macular Oedema Secondary to RVO.

Read the detailed description

This is an open-label, single group, single dose study in subjects with nAMD or Macular Oedema Secondary to RVO.

Screening and Day 1 can be performed on the same day. Subjects will receive ITV injection of SB11 PFS (0.5 mg ranibizumab in 0.05 mL) on Day 1, and follow up visit will be made on Day 1 (+2).

Being tested
SB11 PFS
Medical subject headings
Macular Edema, Retinal Vein Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SB11 PFSCombination product

    Also called Ranibizumab

    SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for ITV injection

Study groups in NCT06176963
Study groupRoleWhat they receive
SB11 PFSExperimentalSubjects received a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution.
Receives: Combination Product: SB11 PFS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Successful Task Completions

    Total of 12 tasks were evaluated, and the percentage of HCP's successful task completions were measured.

    Participating HCPs were allotted sufficient time to review the instructions for use (IFU) before preparing and administering the ITV injection on Day 1. HCP participants did not receive any additional training for the SB11 PFS prior to or during the study.

    "Percentage of successful task completions" was used as the unit of measure, as one SB11 PFS administration procedure is consisted of 12 tasks and the primary endpoint was the percentage of successful tasks completion among total attempts in this study.

    Measured: Day 1

Secondary outcomes (2)

  1. Percentage of Successful Completion on Critical Tasks

    Total of 6 tasks were considered as critical task, and the percentage of HCP's successful completion on critical tasks were evaluated.

    "Percentage of successful task completions" was used as the unit of measure, as one SB11 PFS administration procedure is consisted of 12 tasks and the secondary endpoint was the percentage of successful critical tasks (total of 6) completion among total attempts in this study.

    Measured: Day 1

  2. Percentage of Successful Completion on Essential Tasks

    Total of 6 tasks were considered as essential task, and the percentage of HCP's successful completion on essential tasks were evaluated.

    "Percentage of successful task completions" was used as the unit of measure, as one SB11 PFS administration procedure is consisted of 12 tasks and the secondary endpoint was the percentage of successful essential tasks (total of 6) completion among total attempts in this study.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2023
  2. Study start21 Nov 2023
  3. Primary completion30 Nov 2023
  4. Study completion12 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06176963
Sponsor's protocol ID
SB11-2001
Status last verified
Dec 2024
First submitted
11 Dec 2023
Last updated
30 Dec 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee Y, Zalewski D, Oleksy P, Wylegala E, Orski M, Lee J, Kim S. Usability of the SB11 Pre-filled Syringe (PFS) in Patients with Retinal Diseases. Adv Ther. 2024 Aug;41(8):3426-3436. doi: 10.1007/s12325-024-02937-3. Epub 2024 Jul 8.

    PubMed 38976126

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SB11 PFS in people with Neovascular Age-related Macular Degeneration and Macular Edema, run by Samsung Bioepis Co., Ltd. at 3 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Successful Task Completions (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06176963, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.

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