The Effect of Systemic Parameters and Baseline Characteristics in Short-Term Response Analysis with Intravitreal Ranibizumab in Treatment-Naive Patients with Neovascular Age-Related Macular Degeneration

Pharmaceutics · 12 authors, 7 centres

AI SUMMARY

FIDELITY 92%

POPULATION44 treatment-naive patients with neovascular age-related macular degeneration (nAMD), aged ≥55 years, with baseline visual acuity >20 ETDRS letters

INTERVENTIONThree monthly intravitreal injections of ranibizumab (Lucentis) followed by treat-and-extend regimen

COMPARISONGood responders (resolution of intraretinal/subretinal fluid, CRT reduction, ≥5 ETDRS letter improvement) vs. poor/non-responders (<25% CRT reduction, <5 letter VA change, persistent/new fluid)

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AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

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TL;DR

In a prospective study of 44 treatment-naive neovascular AMD patients, higher baseline uric acid levels were significantly associated with better short-term response to ranibizumab (p=0.007), while female sex and statin use predicted worse response. Cholesterol and white blood cell count decreased significantly over time with treatment, suggesting they may be useful for monitoring response. These findings highlight potential systemic biomarkers to identify poor responders before initiating anti-VEGF therapy.

Full summary

2,793 CHARS

**Background:** Neovascular age-related macular degeneration (nAMD) is a leading cause of irreversible vision loss in older adults. Anti-VEGF therapy with ranibizumab is standard, but response varies. Identifying predictive biomarkers could enable personalized treatment. This study aimed to evaluate demographic, biochemical, and inflammatory parameters as predictors of short-term response to ranibizumab in treatment-naive nAMD patients.

**Methods:** A prospective observational study enrolled 44 treatment-naive nAMD patients (median age 80 years, 59% female) at the University Hospital of Santiago de Compostela. Patients received three monthly intravitreal ranibizumab injections (loading dose) followed by treat-and-extend. Baseline and month 4 assessments included visual acuity (ETDRS letters), optical coherence tomography (CRT, intraretinal/subretinal fluid), and blood tests (biochemical panel, complete blood count, inflammatory cytokines IL1b, IL2R, IL5, IL6, IL8, IL10, TNF-alpha). Response was classified per Amoaku et al.: good responders (fluid resolution, CRT reduction, ≥5 letter improvement) vs. poor/non-responders (<25% CRT reduction, <5 letter change, persistent/new fluid). Statistical analysis used Wilcoxon signed-rank, Mann-Whitney U, chi-square/Fisher's exact tests, and logistic regression.

**Key Results:** Of 44 patients, 24 were good responders and 20 poor responders. Women had significantly worse outcomes (p=0.014). Statin use trended toward worse response (p=0.068). Uric acid was significantly higher in good responders at baseline (median 5.7 mg/dL, IQR 4.3–6.5 vs. 4.5 mg/dL, IQR 3.7–5.1; p=0.007), with a one-point difference; post-treatment difference was not significant (p=0.071). Cholesterol decreased significantly overall (188 to 176 mg/dL, p=0.022) and in poor responders (191 to 175 mg/dL, p=0.015). White blood cell count decreased significantly overall (6.92 to 6.22 ×10^3/μL, p=0.028) and in poor responders (6.99 to 6.32 ×10^3/μL, p=0.030). Neutrophils also decreased significantly overall (4.48 to 3.73 ×10^3/μL, p=0.012) and in poor responders (4.60 to 3.60 ×10^3/μL, p=0.044). Cytokines (IL6, TNF-alpha) decreased but not significantly. Logistic regression identified female sex and statin use as negative prognostic factors.

**Clinical Implications:** Baseline uric acid may help identify potential non-responders before initiating ranibizumab, though values remained within normal range. Cholesterol and white blood cell count could serve as monitoring markers for short-term response. The worse prognosis in women and statin users warrants further investigation. Limitations include small sample size, single-center design, and short follow-up. Larger studies are needed to confirm these associations and explore causal mechanisms.

PICO

PPOPULATION

44 treatment-naive patients with neovascular age-related macular degeneration (nAMD), aged ≥55 years, with baseline visual acuity >20 ETDRS letters

IINTERVENTION

Three monthly intravitreal injections of ranibizumab (Lucentis) followed by treat-and-extend regimen

OOUTCOME

Short-term treatment response at month 4; association with demographic, biochemical, and inflammatory parameters

STUDY TYPE

cohort

SPECIALTY

ophthalmology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

92% · A

ORIGINAL PAPER

PMC10818382

The Effect of Systemic Parameters and Baseline Characteristics in Short-Term Response Analysis with Intravitreal Ranibizumab in Treatment-Naive Patients with Neovascular Age-Related Macular Degeneration

Pharmaceutics

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ABSTRACT

Anti-vascular endothelial growth factor drugs keep being the main therapy for neovascular age-related macular degeneration (AMD). Possible predictive parameters (demographic, biochemical and/or inflammatory) could anticipate short-term treatment response with ranibizumab. 46 treatment-naive patients were included in a prospective observational study. They underwent three monthly injections of intravitreal ranibizumab for neovascular AMD and the clinical examination was made at baseline and one month after the third injection. Demographic characteristics, co-morbidities and concomitant treatments were recorded at the baseline visit. Biochemical parameters, complete blood count and inflammation biomarkers were also measured at these times. Uric Acid was found to be statistically significant with a one-point difference between good and poor responders in both basal and treated patients, but only in basal parameters was statistical significance reached ( p = 0.007 vs. p = 0.071 in treated patients). Cholesterol and inflammatory parameters such as white blood cell count and neutrophils were significantly reduced over time when treated with intravitreal ranibizumab. On the other hand, women seemed to have a worse prognosis for short-term response to intravitreal ranibizumab treatment. Uric acid may help identify possible non-responders before initial treatment with ranibizumab, and cholesterol and white blood cells could be good candidates to monitor short-term response to ranibizumab treatment.

CITATION EXPORT

Laura García-Quintanilla, Pablo Almuiña-Varela, María José Rodríguez-Cid et al.. The Effect of Systemic Parameters and Baseline Characteristics in Short-Term Response Analysis with Intravitreal Ranibizumab in Treatment-Naive Patients with Neovascular Age-Related Macular Degeneration. Pharmaceutics. (2024). https://doi.org/10.3390/pharmaceutics16010105

AUTHORS

12 · 7 CENTRES

Laura García-Quintanilla, Pablo Almuiña-Varela, María José Rodríguez-Cid, María Gil-Martínez, Maximino J. Abraldes, Francisco Gómez-Ulla, Miguel González-Barcia, Cristina Mondelo-García, Ana Estany-Gestal, Francisco J. Otero-Espinar, Maribel Fernández-Rodríguez, Anxo Fernández-Ferreiro

1Pharmacy Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, Spain; [email protected] (L.G.-Q.); [email protected] (M.G.-B.); [email protected] (C.M.-G.)
2Clinical Pharmacology Group, Health Research Institute of Santiago de Compostela (IDIS), 15706 Santiago de Compostela, Spain; [email protected]
3Pharmacology, Pharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy, University of Santiago de Compostela (USC), 15782 Santiago de Compostela, Spain; [email protected]
4Ophthalmology Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, Spain; [email protected] (M.J.R.-C.); [email protected] (M.G.-M.); [email protected] (M.J.A.)
5Instituto Oftalmológico Gómez-Ulla, 15706 Santiago de Compostela, Spain; [email protected]
6Department of Surgery, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain
7FIDIS-Unidad de Epidemiología e Investigación Clínica, 15706 Santiago de Compostela, Spain; [email protected]

EDITOR / REVIEWER

Montse Mitjans Arnal