Injection Intervals in Real-world Neovascular Age-related Macular Degeneration (nAMD) Patients Switching to Brolucizumab With at Least 12 Months of Follow-up
- Conditions
- Neovascular Age-related Macular Degeneration
- Registration Number
- NCT06178770
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 414
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in injection interval from baseline to Month 12 for BRO and ALT cohorts Baseline, Month 12
- Secondary Outcome Measures
Name Time Method Age Baseline 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 Ocular adverse events (AEs) in eyes treated with at least one brolucizumab injection Up to 3 years Pigment epithelial detachment (PED) Baseline Gender Baseline Central macular thickness (CMT) Baseline, Month 12 and Month 18 Subretinal fluid (SRF) Baseline Median time (days) from AE to resolution Up to 3 years 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 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 Intraretinal fluid (IRF) Baseline Number of brolucizumab injections and non-brolucizumab injections from first brolucizumab injection to 12 months (for ALT cohort) Baseline, Month 12 Proportion of patients in different levels of vision recovery after AE resolution 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 number of brolucizumab injections pre-AE including the index injection Up to 3 years
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States