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

NCT06176963 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SB11-2001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

Brief 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 Secondary to RVO.

Conditions

Neovascular Age-related Macular Degeneration; Macular Edema; Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (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.

  Day 1

Secondary Outcomes (2)

• Percentage of Successful Completion on Critical Tasks

  Day 1

• Percentage of Successful Completion on Essential Tasks

  Day 1

Study Arms (1)

SB11 PFS

EXPERIMENTAL

Subjects received a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution.

Combination Product: SB11 PFS

Interventions

SB11 PFS COMBINATION_PRODUCT

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

Also known as: Ranibizumab

SB11 PFS

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (3)

SB Investigational Site

Katowice, Poland

Location

SB Investigational Site

Krakow, Poland

Location

SB Investigational Site

Olsztyn, Poland

Location

Related Publications (1)

• 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.

  PMID: 38976126 DERIVED

MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular 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: Director of Clinical Trials
• Organization: Samsung Bioepis Co., Ltd

sbregistry@samsung.com

+82-32-728-0371

Study Officials

• Piotr Oleksy, M.D.

  Centrum Medyczne Dietla 19 Krakow

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: November 21, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 12, 2023
• Last Updated: December 30, 2024
• Results First Posted: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3)