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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06178770
• Other study ID #: CRTH258A2018
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: December 12, 2022

Study information

• Verified date: December 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: December 12, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Locations

Country	Name	City	State
United States	Novartis	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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