Trial Outcomes & Findings for Study to Collect Safety and ECG Data on Brolucizumab 6 mg Intravitreal Treatment in Patients With Wet AMD (NCT NCT03954626)

Last Updated: 2021-01-05

Results Overview

Incidence between 20 and 24 h post-injection of clinically relevant treatment emergent changes in heart rate (HR), pulse rate (PR), QRS, and QTc (heart rate corrected QT using Fridericia's formula, QTcF) interval (ms). This is a composite endpoint capturing all 4 parameters and 3 time-points in one Outcome Measure.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

14 participants

Primary outcome timeframe

Baseline, Hour 20, Hour 22, Hour 24

Results posted on

2021-01-05

Participant Flow

The study enrolled patients from 3 centers from the United States.14 patients were enrolled and analyzed in the study.

Participant milestones

Participant milestones
Measure	RTH258 Intravitreal injection
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Collect Safety and ECG Data on Brolucizumab 6 mg Intravitreal Treatment in Patients With Wet AMD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RTH258 n=14 Participants Intravitreal injection
Age, Continuous	75.7 years STANDARD_DEVIATION 6.57 • n=93 Participants
Sex: Female, Male Female	8 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline, Hour 20, Hour 22, Hour 24

Population: The safety analysis, which included all patients who received one intravitreal injection of brolucizumab 6 mg.

Outcome measures

Outcome measures
Measure	RTH258 n=14 Participants Intravitreal injection
Frequency of Clinically Relevant Treatment Emergent ECG Changes After Intravitreal Injection of Brolucizumab 6 mg in Patients With nAMD	0 Number of events

Adverse Events

RTH258

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RTH258 n=14 participants at risk Intravitreal injection
Investigations Intraocular pressure increased	7.1% 1/14 • Adverse events were collected from date of written informed consent until the end of study visit (Day 8)

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862 778 8300

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER