- ICH GCP
- US Clinical Trials Registry
- 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
April 26, 2023 updated by: Novartis Pharmaceuticals
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
63
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bangalore, India
- Narayana Nethralaya
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Kolkata, India
- Disha Eye Hospital
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Kolkata, India
- Susrut Eye Foundation and Research Center
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Rajkot, India
- Dr. Milan's Retina Care Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
This was a retrospective, noninterventional cohort study
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients with absence or reduction of IRF at Month 3 compared to baseline
Time Frame: From baseline to Month 3
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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.
|
From baseline to Month 3
|
Percentage of patients with absence or reduction of SRF at Month 3 compared to baseline
Time Frame: 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.
|
From baseline to Month 3
|
Percentage of patients with absence or reduction of PED at Month 3 compared to baseline
Time Frame: 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.
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From baseline to Month 3
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change from baseline in BCVA at Month 3 as measured by logarithm of the minimum angle of resolution (logMAR)
Time Frame: Baseline and Month 3
|
Baseline and Month 3
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Percentage of patients with absence or reduction of IRF at Months 1 and 2 compared to baseline
Time Frame: Baseline, Months 1 and 2
|
Baseline, Months 1 and 2
|
Percentage of patients with absence or reduction of SRF at Months 1 and 2 compared to baseline
Time Frame: Baseline, Months 1 and 2
|
Baseline, Months 1 and 2
|
Percentage of patients with absence or reduction of PED at Months 1 and 2 compared to baseline
Time Frame: Baseline, Months 1 and 2
|
Baseline, Months 1 and 2
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Mean change from baseline in CRT at Months 1, 2, and 3 as assessed by optical coherence tomography (OCT)
Time Frame: Baseline, Months 1, 2, and 3
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Baseline, Months 1, 2, and 3
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Number of brolucizumab injections during Months 1, 2, and 3 of brolucizumab treatment
Time Frame: Months 1, 2, and 3
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Months 1, 2, and 3
|
Number of non-injection visits during Months 1, 2, and 3 of brolucizumab treatment
Time Frame: Months 1, 2, and 3
|
Months 1, 2, and 3
|
Number of visits during Months 1, 2, and 3 of brolucizumab treatment
Time Frame: Months 1, 2, and 3
|
Months 1, 2, and 3
|
Number of patients with treatment-emergent adverse events
Time Frame: Baseline to Month 3
|
Baseline to Month 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2022
Primary Completion (Actual)
April 22, 2022
Study Completion (Actual)
April 22, 2022
Study Registration Dates
First Submitted
April 19, 2023
First Submitted That Met QC Criteria
April 26, 2023
First Posted (Actual)
April 28, 2023
Study Record Updates
Last Update Posted (Actual)
April 28, 2023
Last Update Submitted That Met QC Criteria
April 26, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRTH258AIN02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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