NCT03954626

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

Completed Phase 3 Results posted Last updated 5 January 2021

What this trial tests

Phase 3 trial testing brolucuzumab 6 mg IVT in Age-Related Macular Degeneration in 14 participants. Completed in 31 July 2019.

Timeline

7 June 2019

Primary endpoint
9 July 2019

31 July 2019

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	7 June 2019
Primary completion	9 July 2019
Estimated completion	31 July 2019
Sites	3 locations across Puerto Rico, United States

Drugs / interventions tested

• brolucuzumab 6 mg IVT — full drug profile →

Conditions studied

• Age-Related Macular Degeneration — all drugs for Age-Related Macular Degeneration →
• Macular Degeneration — all drugs for Macular Degeneration →
• Wet Macular Degeneration — all drugs for Wet Macular Degeneration →
• Retinal Degeneration — all drugs for Retinal Degeneration →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

50 and older, any sex, with Age-Related Macular Degeneration or Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Frequency of Clinically Relevant Treatment Emergent ECG Changes After Intravitreal Injection of Brolucizumab 6 mg in Patients With nAMD Primary · Baseline, Hour 20, Hour 22, Hour 24

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.

Group	Value	95% CI
RTH258	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from date of written informed consent until the end of study visit (Day 8). Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RTH258

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (1 terms — click to expand)

Reaction	System	RTH258
Intraocular pressure increased	Investigations	—

Data from ClinicalTrials.gov NCT03954626 adverse events section.

Sponsor's own description

The purpose of this study was to collect ECG data after a single IVT injection of brolucizumab 6 mg in patients with neovascular age-related macular degeneration (nAMD).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent Advances in Age-Related Macular Degeneration Therapies.
   Fabre M, Mateo L, Lamaa D, Baillif S, et al · · 2022 · cited 68× · PMID 36014339 · DOI 10.3390/molecules27165089
2. Evaluation of cardiac parameters and other safety outcomes of brolucizumab treatment in patients with neovascular age-related macular degeneration.
   Zakaria N, Guerard N, Emanuelli A, Dugel P, et al · · 2022 · cited 4× · PMID 35301822 · DOI 10.1002/prp2.897