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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • India
      • Bangalore, India
        • Narayana Nethralaya
      • Kolkata, India
        • Disha Eye Hospital
      • Kolkata, India
        • Susrut Eye Foundation and Research Center
      • Rajkot, India
        • Dr. Milan's Retina Care Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
From baseline to Month 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
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
Baseline, Months 1, 2, and 3
Number of brolucizumab injections during Months 1, 2, and 3 of brolucizumab treatment
Time Frame: Months 1, 2, and 3
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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