Abstract
Purpose :
To evaluate treatment intervals, morphological and functional outcomes of intravitreal brolucizumab on neovascular age-related macular degeneration (nAMD) lesions with limited response to aflibercept in a treat and extend regimen (TER).
Methods :
The prospective study arm included patients with aflibercept pretreatment in a TER who failed to be extended to >4 and >6 weeks intervals, respectively. Study treatments followed a TER with extension in 2-weeks-steps. Evaluations included treatment intervals; best-corrected visual acuity (BCVA); central subfield thickness (CST) and further morphological features at Optical Coherence Tomography. A morphological matched and identically pretreated control group without switch to brolucizumab was assessed retrospectively.
Results :
15 patients were included in each, the study and the control arm. In two patients brolucizumab was stopped due to mild adverse events, in 10 due to the Novartis announcement not further recommending brolucizumab in intervals <8 weeks after loading dose. These patients were switched back to aflibercept and followed per protocol. Patients received between 2 and 11 brolucizumab treatments (mean 8.1±2.9). For both groups, mean interval at baseline was 4.1±0.5 weeks. At 12 months, the interval in the study group increased to 5.1±1.8 (p=0.051) weeks (inclusive patients with re-switch to aflibercept). Under brolucizumab the mean interval was 5.5±1.9 weeks (p=0.007) and 33% of the patients reached a 2-week interval extension without recurrence. In the control group no significant change in mean interval occurred. BCVA remained stable in both, the study and control group through 12 months. In the study group, CST significantly decreased from 410±173µm to 356±118µm at month 1 (p=0.0204), but showed a slight increase to 384±154µm at month 12. Retina was dry (no intra-/subretinal fluid) in 40% at baseline, 73% at month 6 and 40% at month 12. In the control group, CST at baseline was 395±66µm, without significant change to month 12. During brolucizumab treatment two patients experienced mild intraocular inflammation, no other adverse events occurred.
Conclusions :
Brolucizumab showed the potential for morphological improvements and increase in treatment interval length in a TER in nAMD with limited aflibercept treatment response. Due to restrictions regarding brolucizumab treatment in intervals <8 weeks the use was limited.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.