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OpenTrials
Completed

NCT Number: NCT05834075

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

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.

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Key information

Conditions

Neurovascular Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Narayana Nethralaya, Bangalore, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  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.

Secondary outcomes

  1. 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

  2. Percentage of patients with absence or reduction of IRF at Months 1 and 2 compared to baseline

    Time frame: Baseline, Months 1 and 2

  3. Percentage of patients with absence or reduction of SRF at Months 1 and 2 compared to baseline

    Time frame: Baseline, Months 1 and 2

  4. Percentage of patients with absence or reduction of PED at Months 1 and 2 compared to baseline

    Time frame: Baseline, Months 1 and 2

  5. 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

  6. Number of brolucizumab injections during Months 1, 2, and 3 of brolucizumab treatment

    Time frame: Months 1, 2, and 3

  7. Number of non-injection visits during Months 1, 2, and 3 of brolucizumab treatment

    Time frame: Months 1, 2, and 3

  8. Number of visits during Months 1, 2, and 3 of brolucizumab treatment

    Time frame: Months 1, 2, and 3

  9. Number of patients with treatment-emergent adverse events

    Time frame: Baseline to Month 3

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2023
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.