Trial Outcomes & Findings for A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO (NCT NCT06176963)

Last Updated: 2024-12-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Day 1

Results posted on

2024-12-30

Participant Flow

34 subjects were enrolled for this study and 4 HCPs participated in this study.

Participant milestones

Participant milestones
Measure	SB11 PFS - Subjects Subjects received a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution (Day 1). 4 HCPs participated in this study to administer SB11 PFS to total of 34 subjects.
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SB11 PFS n=34 Participants Subjects received a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution. SB11 PFS: SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for ITV injection
Age, Continuous	74.1 years STANDARD_DEVIATION 7.45 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Main Indication Neovascular AMD	32 Participants n=5 Participants
Main Indication Macular Oedema Secondary to RVO	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Overall, 4 participating HCPs performed tasks on 34 enrolled patients (a single PFS ITV injection per patient) leading to a total of "34 attempts" for each tasks in this study.

Outcome measures

Outcome measures
Measure	SB11 PFS n=34 attempts HCPs administered a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution to subjects. SB11 PFS: SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for ITV injection
Percentage of Successful Task Completions Remove the needle cap	100 Percentage of successful task completion
Percentage of Successful Task Completions Open the carton	100 Percentage of successful task completion
Percentage of Successful Task Completions Remove contents	100 Percentage of successful task completion
Percentage of Successful Task Completions Peel the lid off the blister pack	100 Percentage of successful task completion
Percentage of Successful Task Completions Carefully remove the PFS from the blister using aseptic technique	100 Percentage of successful task completion
Percentage of Successful Task Completions Remove the syringe cap	100 Percentage of successful task completion
Percentage of Successful Task Completions Attach a needle	100 Percentage of successful task completion
Percentage of Successful Task Completions Set the dose	100 Percentage of successful task completion
Percentage of Successful Task Completions Insert the needle into the injection site	100 Percentage of successful task completion
Percentage of Successful Task Completions Press the plunger down to inject the medication	100 Percentage of successful task completion
Percentage of Successful Task Completions Remove the needle from the injection site	100 Percentage of successful task completion
Percentage of Successful Task Completions Dispose product	100 Percentage of successful task completion

SECONDARY outcome

Timeframe: Day 1

Population: Overall, 4 participating HCPs performed tasks on 34 enrolled patients (a single PFS ITV injection per patient) leading to a total of "34 attempts" for each tasks in this study.

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.

Outcome measures

Outcome measures
Measure	SB11 PFS n=34 attempts HCPs administered a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution to subjects. SB11 PFS: SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for ITV injection
Percentage of Successful Completion on Critical Tasks	100 Percentage of successful task completion

SECONDARY outcome

Timeframe: Day 1

Population: Overall, 4 participating HCPs performed tasks on 34 enrolled patients (a single PFS ITV injection per patient) leading to a total of "34 attempts" for each tasks in this study.

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.

Outcome measures

Outcome measures
Measure	SB11 PFS n=34 attempts HCPs administered a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution to subjects. SB11 PFS: SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for ITV injection
Percentage of Successful Completion on Essential Tasks	100 Percentage of successful task completion

Adverse Events

SB11 PFS

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SB11 PFS n=34 participants at risk Subjects received a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution. SB11 PFS: SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for ITV injection
Eye disorders Ocular discomfort	2.9% 1/34 • Number of events 1 • Overall Period (Day 7) Safety analysis was performed in subjects who received at least one IP during the study period, and all 34 (100.0%) subjects were included.
Eye disorders Ocular hyperaemia	2.9% 1/34 • Number of events 1 • Overall Period (Day 7) Safety analysis was performed in subjects who received at least one IP during the study period, and all 34 (100.0%) subjects were included.
Infections and infestations Nasopharyngitis	2.9% 1/34 • Number of events 1 • Overall Period (Day 7) Safety analysis was performed in subjects who received at least one IP during the study period, and all 34 (100.0%) subjects were included.

Additional Information

Director of Clinical Trials

Samsung Bioepis Co., Ltd

Phone: +82-32-728-0371

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place