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A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT06176963•Samsung Bioepis Co., Ltd.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (3)

SB Investigational Site

Katowice, Poland

SB Investigational Site

Krakow, Poland

SB Investigational Site

Olsztyn, Poland

Key Dates

Start Date

November 21, 2023

Primary Completion Date

November 30, 2023

Completion Date

December 12, 2023

Last Updated

December 30, 2024

Enrollment

ACTUAL participants

Conditions

Neovascular Age-related Macular DegenerationMacular EdemaRetinal Vein Occlusion

Interventions

SB11 PFS

COMBINATION_PRODUCT

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

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