Clinical trial NCT06178770: Injection Intervals in Real-world Neovascular Age-related Macular Degeneration (nAMD) Patients Switching to Brolucizumab With at Least 12 Months of Follow-up
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neovascular Age-related Macular Degeneration
Keywords: nAMD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-12-21
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean change in injection interval from baseline to Month 12 for BRO and ALT cohorts
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Change in injection interval from first brolucizumab injection to Month 18 for BRO and ALT cohorts
timeFrame: Baseline, Month 18
measure: Change in visual acuity (VA) from first brolucizumab injection to Month 12 (for BRO and ALT cohorts) and Month 18 (for BRO cohort)
timeFrame: Baseline, Months 12 and 18
measure: Change in central macular thickness (CMT) from first brolucizumab injection to Month 12 (for BRO and ALT cohorts) and Month 18 (for BRO cohort)
timeFrame: Baseline, Months 12 and 18
measure: Age
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] Letters)
timeFrame: Baseline, Month 12 and Month 18
measure: Anti-VEGF treatment status
timeFrame: Baseline
measure: Last injection interval before switch to brolucizumab in prior-treated eyes
timeFrame: Baseline
measure: Central macular thickness (CMT)
timeFrame: Baseline, Month 12 and Month 18
measure: Intraretinal fluid (IRF)
timeFrame: Baseline
measure: Subretinal fluid (SRF)
timeFrame: Baseline
measure: Pigment epithelial detachment (PED)
timeFrame: Baseline
measure: Number of brolucizumab injections and non-brolucizumab injections from first brolucizumab injection to 12 months (for ALT cohort)
timeFrame: Baseline, Month 12
measure: Ocular adverse events (AEs) in eyes treated with at least one brolucizumab injection
timeFrame: Up to 3 years
measure: Median time (days) from first brolucizumab injection to AE
timeFrame: Up to 3 years
measure: Median time (days) from last brolucizumab injection pre-AE to AE
timeFrame: Up to 3 years
measure: Median time (days) from AE to resolution
timeFrame: Up to 3 years
measure: Median number of brolucizumab injections pre-AE including the index injection
timeFrame: Up to 3 years
measure: Proportion of patients in different levels of vision recovery after AE resolution
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: