A Retrospective Study to Evaluate the Early Real-world Evidence of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD) in India

Novartis

Status: Completed

Conditions: Neurovascular Age-related Macular Degeneration

Study type: Observational

Funder types: Industry

Identifiers

NCT05834075

CRTH258AIN02

Details and patient eligibility

About

This non-interventional, retrospective, observational, noncomparative, non-randomized, single-arm, multi-centre study included patients (≥50 years) diagnosed with neovascular age-related macular degeneration (nAMD) in at least 1 eye. Anonymized data of patients treated with brolucizumab intravitreal injection (IVI) who had received the first dose of brolucizumab between 01 October 2020 and 31 March 2021 was collected. Patients could either be treatment-naïve or previously treated with single or a combination of other IVI of anti-vascular endothelial growth factors (VEGFs). The primary outcome measure was the change in fluid levels (intra-retinal fluid [IRF], sub-retinal fluid [SRF], and pigment epithelial detachment [PED]) from baseline to Month 3. Secondary outcome measures included change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT), number of brolucizumab injections, and safety (number of adverse events [AEs]). Descriptive statistics were tabulated for the demographic and clinical characteristics as well as outcome variables.

Enrollment: 63 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment-naïve nAMD patients or patients previously treated with a single or a combination of other intravitreal anti-VEGFs
• Patients (male or female) ≥50 years of age at the index date
• Patients with visual acuity (VA) and optical coherence tomography (OCT) assessments at baseline and at least 1 month after initiating treatment with brolucizumab
• Patients treated with IVI of brolucizumab (received the first dose of anti-VEGF injection during the index period [01 October 2020 to 31 March 2021])

Exclusion criteria

• Patients with dry AMD, geographic atrophy, and other retinal diseases in the study eye
• Patients who were part of any other nAMD trial/study during the study period
• Patients undergoing additional ocular treatment along with other anti-VEGF agents