Original articleMorphologic Parameters Relevant for Visual Outcome During Anti-Angiogenic Therapy of Neovascular Age-Related Macular Degeneration
Section snippets
Study Design
The EXCITE study was designed as a 1-year, randomized, double-masked, active-controlled, multicenter, phase IIIb study in patients with subfoveal CNV secondary to AMD, comparing the efficacy and safety of quarterly dosing regimens of ranibizumab in 2 different dosages with a monthly dosing regimen during the maintenance phase, that is, from month 3 onward.
Eligible patients were randomly assigned in a 1:1:1 ratio to any of the following 3 double-masked treatment arms (Fig 1): loading dose of 3
Patients
A total of 353 patients at 59 study sites were randomized for treatment with the study medication. The study was completed by 106 patients in the ranibizumab 0.3 mg quarterly group (arm A), 95 patients in the ranibizumab 0.5 mg quarterly group (arm B), and 103 patients in the ranibizumab 0.3 mg monthly group (arm C). The patients' disposition, baseline and ocular disease characteristics, treatment exposure, adverse events, BCVA, and CRT time course and contrast sensitivity analysis in the 3
Discussion
In the present investigation, change in overall CRT and individual morphologic parameters (IRC, SRF, PED) were documented in a quantitative and qualitative manner and correlated with functional outcomes during a 12-month follow-up. Datasets from a prospective multicenter trial offering a direct comparison between a continuous immediate re-treatment strategy and a discontinuous delayed regimen allowing exacerbation of morphologic alteration were analyzed. Certified graders of an independent
References (32)
- et al.
Vascular endothelial growth factor in eye disease
Prog Retin Eye Res
(2008) - et al.
The role of vascular endothelial growth factor and other endogenous interplayers in age-related macular degeneration
Prog Retin Eye Res
(2008) - et al.
Ranibizumab inhibits multiple forms of biologically active vascular endothelial growth factor in vitro and in vivo
Exp Eye Res
(2007) - et al.
HORIZON: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age-related macular degeneration
Ophthalmology
(2012) - et al.
A Phase IIIb study to evaluate the safety of ranibizumab in subjects with neovascular age-related macular degeneration
Ophthalmology
(2009) - et al.
Safety and efficacy of a flexible dosing regimen of ranibizumab in neovascular age-related macular degeneration: the SUSTAIN Study
Ophthalmology
(2011) - et al.
Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results
Ophthalmology
(2012) - et al.
Twelve-month efficacy and safety of 0.5 mg or 2.0 mg ranibizumab in patients with subfoveal neovascular age-related macular degeneration
Ophthalmology
(2013) - et al.
Efficacy and safety of monthly versus quarterly ranibizumab treatment in neovascular age-related macular degeneration: the EXCITE Study
Ophthalmology
(2011) - et al.
Evaluation of injection frequency and visual acuity outcomes for ranibizumab monotherapy in exudative age-related macular degeneration
Ophthalmology
(2009)
Optical coherence tomography grading reproducibility during the Comparison of Age-Related Macular Degeneration Treatments Trials
Ophthalmology
Baseline predictors for one-year visual outcomes with ranibizumab or bevacizumab for neovascular age-related macular degeneration
Ophthalmology
Characteristics of patients losing vision after 2 years of monthly dosing in the phase III ranibizumab clinical trials
Ophthalmology
Targeting VEGF-A to treat cancer and age-related macular degeneration
Annu Rev Med
Development of ranibizumab, an anti-vascular endothelial growth factor antigen binding fragment, as therapy for neovascular age-related macular degeneration
Retina
Ranibizumab for neovascular age-related macular degeneration
N Engl J Med
Cited by (149)
Practical guidance for imaging biomarkers in exudative age-related macular degeneration
2023, Survey of OphthalmologyOCT Predictors of 3-Year Visual Outcome for Type 3 Macular Neovascularization
2022, Ophthalmology RetinaCitation Excerpt :Indeed, the presence of SRF at baseline was an independent negative predictor of final BCVA in the multivariate model (P = 0.008). The role of SRF and IRF as possible outcome predictors was intensively analyzed in previous papers.19,21,29–32 Several studies reported that baseline IRF is associated with poorer outcomes in nAMD patients,29–32 whereas baseline SRF predicts good visual outcomes in patients receiving anti-VEGF therapy33.
Functional and anatomical outcomes of brolucizumab for nAMD in a real-life setting
2024, Scientific ReportsTexture-Based Radiomic SD-OCT Features Associated With Response to Anti-VEGF Therapy in a Phase III Neovascular AMD Clinical Trial
2024, Translational Vision Science and Technology
The data presented in this paper are the result of independent sub-analysis of the EXCITE study conducted by the VRC without any financial support. The Department of Ophthalmology at the Medical University of Vienna served as a clinical site in the EXCITE study and received regular recompensation for contract research. The sponsor or funding organization had no role in the design or conduct of this research.
Financial Disclosure(s): The author(s) have made the following disclosure(s): U.M.S.-E. was a principal investigator in the EXCITE trial. C.S. is the director of the VRC, which performed the OCT data analysis during the EXCITE study.