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

NCT ID: NCT05834075

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-05

Study Completion Date

2022-04-22

Brief Summary

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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

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Conditions

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Neurovascular Age-related Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Narayana Nethralaya

Bangalore, , India

Site Status

Disha Eye Hospital

Kolkata, , India

Site Status

Susrut Eye Foundation and Research Center

Kolkata, , India

Site Status

Dr. Milan's Retina Care Center

Rajkot, , India

Site Status

Countries

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India

Other Identifiers

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CRTH258AIN02

Identifier Type: -

Identifier Source: org_study_id