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

Completed

• Conditions: Neurovascular Age-related Macular Degeneration

• Registration Number: NCT05834075
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-05
• Primary Completion: 2022-04-22
• Study Completion: 2022-04-22
• Status Verified: 2023-04
• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-04-26
• Last Update Submitted: 2023-04-26
• Study First Posted: 2023-04-28
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with absence or reduction of PED at Month 3 compared to baseline	From baseline to Month 3	Percentage of patients with either absence of pigment epithelial detachment (PED) at Month 3 or a reduction of PED at Month 3 compared to baseline.
Percentage of patients with absence or reduction of SRF at Month 3 compared to baseline	From baseline to Month 3	Percentage of patients with either absence of sub-retinal fluid (SRF) at Month 3 or a reduction of SRF at Month 3 compared to baseline.
Percentage of patients with absence or reduction of IRF at Month 3 compared to baseline	From baseline to Month 3	Percentage of patients with either absence of intra-retinal fluid (IRF) at Month 3 or a reduction of IRF at Month 3 compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in BCVA at Month 3 as measured by logarithm of the minimum angle of resolution (logMAR)	Baseline and Month 3
Percentage of patients with absence or reduction of IRF at Months 1 and 2 compared to baseline	Baseline, Months 1 and 2
Percentage of patients with absence or reduction of SRF at Months 1 and 2 compared to baseline	Baseline, Months 1 and 2
Number of brolucizumab injections during Months 1, 2, and 3 of brolucizumab treatment	Months 1, 2, and 3
Number of patients with treatment-emergent adverse events	Baseline to Month 3
Percentage of patients with absence or reduction of PED at Months 1 and 2 compared to baseline	Baseline, Months 1 and 2
Mean change from baseline in CRT at Months 1, 2, and 3 as assessed by optical coherence tomography (OCT)	Baseline, Months 1, 2, and 3
Number of visits during Months 1, 2, and 3 of brolucizumab treatment	Months 1, 2, and 3
Number of non-injection visits during Months 1, 2, and 3 of brolucizumab treatment	Months 1, 2, and 3

Trial Locations

Locations (4)

Disha Eye Hospital; 🇮🇳 Kolkata, India

Dr. Milan's Retina Care Center; 🇮🇳 Rajkot, India

Susrut Eye Foundation and Research Center; 🇮🇳 Kolkata, India

Narayana Nethralaya; 🇮🇳 Bangalore, India