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

NCT ID: NCT06176963

Last Updated: 2024-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-21
• Study Completion Date: 2023-12-12

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.

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).

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SB11 PFS

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

Group Type: EXPERIMENTAL

SB11 PFS

Intervention Type: COMBINATION_PRODUCT

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

Interventions

SB11 PFS

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Ranibizumab

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Current systemic infectious disease or therapy for active infectious disease
• Pregnant or lactating women at Screening or at Day 1

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Bioepis Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piotr Oleksy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Centrum Medyczne Dietla 19 Krakow

Locations

SB Investigational Site

Katowice, , Poland

SB Investigational Site

Krakow, , Poland

SB Investigational Site

Olsztyn, , Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 38976126 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SB11-2001

Identifier Type: -

Identifier Source: org_study_id