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

NCT06178770 | Completed

• 1 other identifier: CRTH258A2018
• Study Type: observational
• Target: 414
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

nAMD

Outcome Measures

Primary Outcomes (1)

• Mean change in injection interval from baseline to Month 12 for BRO and ALT cohorts

  Baseline, Month 12

Secondary Outcomes (19)

• 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

• Age

  Baseline

• Gender

  Baseline

Study Arms (5)

Overall cohort

12-month BRO cohort

18-month BRO cohort

12-month ALT cohort

18-month ALT cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 21, 2023
• Study Start: December 1, 2021
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

US (1)