Trial Outcomes & Findings for Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit (NCT NCT05282004)

NCT ID: NCT05282004

Last Updated: 2023-05-10

Results Overview

Number of participants with ocular treatment emergent adverse events were reported.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 36 participants
• Primary outcome timeframe: 31 days
• Results posted on: 2023-05-10

Participant Flow

The study was conducted at 5 study sites in the USA.

Participant milestones

Measure	SOK583A1 40 mg/mL SOK583A1 was provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)
Overall Study STARTED	36
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	SOK583A1 40 mg/mL SOK583A1 was provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)
Overall Study Adverse Event	2

Baseline Characteristics

Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit

Baseline characteristics by cohort

Measure	SOK583A1 40 mg/mL n=36 Participants SOK583A1 was provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)
Age, Continuous	80.9 years STANDARD_DEVIATION 8.45 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	16 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	36 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

PRIMARY outcome

Timeframe: 31 days

Population: Full analysis set (FAS): FAS included all participants who received an injection of study treatment.

Number of participants with ocular treatment emergent adverse events were reported.

Outcome measures

Measure	SOK583A1 40 mg/mL n=36 Participants SOK583A1 was provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)
Number of Participants With Ocular Treatment Emergent Adverse Events	16 Participants

PRIMARY outcome

Timeframe: 31 days

Population: Full analysis set (FAS): FAS included all participants who received an injection of study treatment.

Number of participants with non-ocular treatment emergent adverse events were reported.

Outcome measures

Measure	SOK583A1 40 mg/mL n=36 Participants SOK583A1 was provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)
Number of Participants With Non-ocular Treatment Emergent Adverse Events	3 Participants

Adverse Events

SOK583A1 40 mg/mL

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	SOK583A1 40 mg/mL n=36 participants at risk SOK583A1 was provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)
Infections and infestations Cystitis	2.8% 1/36 • Adverse events were collected throughout the study for 31 days Any signs or symptoms were collected throughout the study for 31 days
Musculoskeletal and connective tissue disorders Arthralgia	2.8% 1/36 • Adverse events were collected throughout the study for 31 days Any signs or symptoms were collected throughout the study for 31 days

Other adverse events

Measure	SOK583A1 40 mg/mL n=36 participants at risk SOK583A1 was provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)
Eye disorders Conjunctival haemorrhage	5.6% 2/36 • Adverse events were collected throughout the study for 31 days Any signs or symptoms were collected throughout the study for 31 days
Eye disorders Vitreous floaters	2.8% 1/36 • Adverse events were collected throughout the study for 31 days Any signs or symptoms were collected throughout the study for 31 days
Infections and infestations COVID-19	2.8% 1/36 • Adverse events were collected throughout the study for 31 days Any signs or symptoms were collected throughout the study for 31 days
Investigations Intraocular pressure increased	41.7% 15/36 • Adverse events were collected throughout the study for 31 days Any signs or symptoms were collected throughout the study for 31 days

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: novartis.email@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Sandoz' agreements with its investigators may vary. However, Sandoz does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER