Injection Intervals in Real-world Neovascular Age-related Macular Degeneration (nAMD) Patients Switching to Brolucizumab With at Least 12 Months of Follow-up

This retrospective study included nAMD patients whose eyes were grouped into the following cohorts, with the overall cohort receiving ≥ 1 brolucizumab injection; the 12-month and 18-month brolucizumab (BRO) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-vascular endothelial growth factor (VEGF) and had ≥3 brolucizumab injections with no other anti-VEGF in the first 12 months (360 days) and 18 months (540 days) of follow-up respectively; and the 12-month and 18-month alternating (ALT) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-VEGF to brolucizumab and had ≥2 brolucizumab injections and ≥1 injection of another anti-VEGF in the first 12 months and 18 months of follow-up, respectively.

Study Overview

• Status: Completed
• Conditions: Neovascular Age-related Macular Degeneration

• Study Type: Observational
• Enrollment (Actual): 414

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

Inclusion Criteria:

• Patients with a diagnosis of nAMD.
• Patients were on a previous anti-VEGF therapy and then switched to brolucizumab.
• Patients remained on brolucizumab for at least 12 months.
• Patients had exactly 360 days or more of follow-up after first brolucizumab injection.
• For BRO cohort only: Patients received at least three injections of brolucizumab during study period.
• For ALT cohort only: Patients received at least two injections of brolucizumab and one injection of another anti-VEGF during the study period.

Exclusion Criteria:

• For BRO cohort only: Patients who received any other anti-VEGF therapy during the 12-month follow-up period.
• Eyes missing bilaterality information in their nAMD diagnosis.
• Eyes missing bilaterality information in their brolucizumab injections.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Overall cohort
12-month BRO cohort
18-month BRO cohort
12-month ALT cohort
18-month ALT cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change in injection interval from baseline to Month 12 for BRO and ALT cohorts	Baseline, Month 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Gender	Baseline
Age	Baseline
Change in injection interval from first brolucizumab injection to Month 18 for BRO and ALT cohorts	Baseline, Month 18
Change in visual acuity (VA) from first brolucizumab injection to Month 12 (for BRO and ALT cohorts) and Month 18 (for BRO cohort)	Baseline, Months 12 and 18
Change in central macular thickness (CMT) from first brolucizumab injection to Month 12 (for BRO and ALT cohorts) and Month 18 (for BRO cohort)	Baseline, Months 12 and 18
Visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] Letters)	Baseline, Month 12 and Month 18
Anti-VEGF treatment status	Baseline
Last injection interval before switch to brolucizumab in prior-treated eyes	Baseline
Central macular thickness (CMT)	Baseline, Month 12 and Month 18
Intraretinal fluid (IRF)	Baseline
Subretinal fluid (SRF)	Baseline
Pigment epithelial detachment (PED)	Baseline
Number of brolucizumab injections and non-brolucizumab injections from first brolucizumab injection to 12 months (for ALT cohort)	Baseline, Month 12
Ocular adverse events (AEs) in eyes treated with at least one brolucizumab injection	Up to 3 years
Median time (days) from first brolucizumab injection to AE	Up to 3 years
Median time (days) from last brolucizumab injection pre-AE to AE	Up to 3 years
Median time (days) from AE to resolution	Up to 3 years
Median number of brolucizumab injections pre-AE including the index injection	Up to 3 years
Proportion of patients in different levels of vision recovery after AE resolution	Up to 3 years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 21, 2023

Study Record Updates

• Last Update Posted (Actual): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: nAMD
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: CRTH258A2018