Neovascular Age-related Macular Degeneration
Conditions
Keywords
nAMD
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in injection interval from baseline to Month 12 for BRO and ALT cohorts | Baseline, Month 12 |
Secondary
| Measure | Time frame |
|---|---|
| Subretinal fluid (SRF) | Baseline |
| Pigment epithelial detachment (PED) | Baseline |
| 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 |
| 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 |
| Intraretinal fluid (IRF) | Baseline |
| Central macular thickness (CMT) | Baseline, Month 12 and Month 18 |
| 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 |
| Change in injection interval from first brolucizumab injection to Month 18 for BRO and ALT cohorts | Baseline, Month 18 |
Countries
United States
Outcome results
None listed