Clinical trial NCT05834075: A Retrospective Study to Evaluate the Early Real-world Evidence of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD) in India
Official title: A Retrospective Study to Evaluate the Early Real-world Evidence of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD) in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurovascular Age-related Macular Degeneration
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-04-28
Enrollment: 63
Sex: ALL
Minimum age (years): 50
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with absence or reduction of IRF at Month 3 compared to baseline
timeFrame: From baseline to Month 3
measure: Percentage of patients with absence or reduction of SRF at Month 3 compared to baseline
timeFrame: From baseline to Month 3
measure: Percentage of patients with absence or reduction of PED at Month 3 compared to baseline
timeFrame: From baseline to Month 3
Secondary outcomes:
measure: Mean change from baseline in BCVA at Month 3 as measured by logarithm of the minimum angle of resolution (logMAR)
timeFrame: Baseline and Month 3
measure: Percentage of patients with absence or reduction of IRF at Months 1 and 2 compared to baseline
timeFrame: Baseline, Months 1 and 2
measure: Percentage of patients with absence or reduction of SRF at Months 1 and 2 compared to baseline
timeFrame: Baseline, Months 1 and 2
measure: Percentage of patients with absence or reduction of PED at Months 1 and 2 compared to baseline
timeFrame: Baseline, Months 1 and 2
measure: Mean change from baseline in CRT at Months 1, 2, and 3 as assessed by optical coherence tomography (OCT)
timeFrame: Baseline, Months 1, 2, and 3
measure: Number of brolucizumab injections during Months 1, 2, and 3 of brolucizumab treatment
timeFrame: Months 1, 2, and 3
measure: Number of non-injection visits during Months 1, 2, and 3 of brolucizumab treatment
timeFrame: Months 1, 2, and 3
measure: Number of visits during Months 1, 2, and 3 of brolucizumab treatment
timeFrame: Months 1, 2, and 3
measure: Number of patients with treatment-emergent adverse events
timeFrame: Baseline to Month 3
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Narayana Nethralaya
city: Kolkata
country: India
facility: Disha Eye Hospital
city: Kolkata
country: India
facility: Susrut Eye Foundation and Research Center
city: Rajkot
country: India
facility: Dr. Milan's Retina Care Center
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: