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Completed

NCT Number: NCT06178770

Injection Intervals in Real-world Neovascular Age-related Macular Degeneration (nAMD) Patients Switching to Brolucizumab With at Least 12 Months of Follow-up

This retrospective study included nAMD patients whose eyes were grouped into the following cohorts, with the overall cohort receiving ≥ 1 brolucizumab injection; the 12-month and 18-month brolucizumab (BRO) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-vascular endothelial growth factor (VEGF) and had ≥3 brolucizumab injections with no other anti-VEGF in the first 12 months (360 days) and 18 months (540 days) of follow-up respectively; and the 12-month and 18-month alternating (ALT) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-VEGF to brolucizumab and had ≥2 brolucizumab injections and ≥1 injection of another anti-VEGF in the first 12 months and 18 months of follow-up, respectively.

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a diagnosis of nAMD.
  • Patients were on a previous anti-VEGF therapy and then switched to brolucizumab.
  • Patients remained on brolucizumab for at least 12 months.
  • Patients had exactly 360 days or more of follow-up after first brolucizumab injection.
  • For BRO cohort only: Patients received at least three injections of brolucizumab during study period.
  • For ALT cohort only: Patients received at least two injections of brolucizumab and one injection of another anti-VEGF during the study period.

Exclusion criteria

  • For BRO cohort only: Patients who received any other anti-VEGF therapy during the 12-month follow-up period.
  • Eyes missing bilaterality information in their nAMD diagnosis.
  • Eyes missing bilaterality information in their brolucizumab injections.

Treatment and study plan

Primary outcomes

  1. Mean change in injection interval from baseline to Month 12 for BRO and ALT cohorts

    Time frame: Baseline, Month 12

Secondary outcomes

  1. Change in injection interval from first brolucizumab injection to Month 18 for BRO and ALT cohorts

    Time frame: Baseline, Month 18

  2. Change in visual acuity (VA) from first brolucizumab injection to Month 12 (for BRO and ALT cohorts) and Month 18 (for BRO cohort)

    Time frame: Baseline, Months 12 and 18

  3. Change in central macular thickness (CMT) from first brolucizumab injection to Month 12 (for BRO and ALT cohorts) and Month 18 (for BRO cohort)

    Time frame: Baseline, Months 12 and 18

  4. Age

    Time frame: Baseline

  5. Gender

    Time frame: Baseline

  6. Visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] Letters)

    Time frame: Baseline, Month 12 and Month 18

  7. Anti-VEGF treatment status

    Time frame: Baseline

  8. Last injection interval before switch to brolucizumab in prior-treated eyes

    Time frame: Baseline

  9. Central macular thickness (CMT)

    Time frame: Baseline, Month 12 and Month 18

  10. Intraretinal fluid (IRF)

    Time frame: Baseline

  11. Subretinal fluid (SRF)

    Time frame: Baseline

  12. Pigment epithelial detachment (PED)

    Time frame: Baseline

  13. Number of brolucizumab injections and non-brolucizumab injections from first brolucizumab injection to 12 months (for ALT cohort)

    Time frame: Baseline, Month 12

  14. Ocular adverse events (AEs) in eyes treated with at least one brolucizumab injection

    Time frame: Up to 3 years

  15. Median time (days) from first brolucizumab injection to AE

    Time frame: Up to 3 years

  16. Median time (days) from last brolucizumab injection pre-AE to AE

    Time frame: Up to 3 years

  17. Median time (days) from AE to resolution

    Time frame: Up to 3 years

  18. Median number of brolucizumab injections pre-AE including the index injection

    Time frame: Up to 3 years

  19. Proportion of patients in different levels of vision recovery after AE resolution

    Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 21, 2023
Registry last updated
Dec 21, 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.

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