Efficacy and safety of treat-and-extend intravitreal brolucizumab in naive and switched patients with macular neovascularization: one-year follow-up study

BMC Ophthalmol. 2024 Oct 4;24(1):436. doi: 10.1186/s12886-024-03706-0.

Abstract

Background: to analyze, at one year, the efficacy and safety of treat-and-extend (T&E) intravitreal (IV) Brolucizumab in patients affected by macular neovascularization (MNV). Both naïve and previously treated (i.e., switched) patients were included, and the data from the two groups were compared.

Methods: anatomical (i.e., central subfoveal thickness, CST; presence of fluid), functional (i.e., best corrected visual acuity, BCVA) and treatment-related (i.e., number of IV injections within the study period; number of patients reaching a 12-weeks interval between treatments) data from 41 eyes of 41 subjects (20 naïve and 21 switched) were analyzed. Patients were treated with 3 monthly IV injections followed by a T&E regimen based on a disease activity assessment performed at each scheduled IV treatment.

Results: significant CST reduction (from 412.1 ± 115.8 to 273.2 ± 61.6; p < 0.05) and BCVA (mean; p) improvement were observed in the naïve group, while in the switched cohort, both parameters were almost stable. In the naïve and switched groups, 55% and 33.5% of patients, respectively, reached a 12-week IV interval at one year, with a mean of 6.55 ± 1 and 7.43 ± 0.68 IV treatments, respectively. One patient with mild anterior uveitis without sequelae was recorded.

Conclusion: In patients with MNV, IV Brolucizumab injections following a T&E regimen demonstrated great efficacy and a good safety profile, with greater anatomical and functional results in naïve patients.

Trial registration: This study was approved by the Local Ethics Committee (protocol number 155/2020, general registry number n°11486, InterHospital Ethics Committee, San Luigi Gonzaga Hospital, Orbassano, Italy).

Keywords: Brolucizumab safety; Intravitreal Brolucizumab; Intravitreal injection interval; Macular neovascularization; Naïve patients; OCT; Switched patients; Treat and extend.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors* / administration & dosage
  • Angiogenesis Inhibitors* / adverse effects
  • Angiogenesis Inhibitors* / therapeutic use
  • Antibodies, Monoclonal, Humanized* / administration & dosage
  • Antibodies, Monoclonal, Humanized* / adverse effects
  • Antibodies, Monoclonal, Humanized* / therapeutic use
  • Drug Substitution
  • Female
  • Follow-Up Studies
  • Humans
  • Intravitreal Injections*
  • Macula Lutea / pathology
  • Male
  • Middle Aged
  • Retinal Neovascularization / drug therapy
  • Retinal Neovascularization / physiopathology
  • Retrospective Studies
  • Tomography, Optical Coherence*
  • Treatment Outcome
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors
  • Visual Acuity* / physiology

Substances

  • Angiogenesis Inhibitors
  • brolucizumab
  • Antibodies, Monoclonal, Humanized
  • Vascular Endothelial Growth Factor A