ABSTRACT
ABSTRACT Purpose: To compare the efficacy of three initial monthly intravitreal aflibercept injections followed by pro re nata (3+PRN) dosing versus five initial monthly intravitreal aflibercept injections followed by pro re nata (5+PRN) dosing in patients with diabetic macular edema. Methods: A total of 60 treatment-naïve patients with macular edema who underwent intravitreal aflibercept injections (2 mg/0.05 mL) with at least one year of follow-up were analyzed in this retrospective and comparative study. The patients were divided into two groups according to the number of intravitreal aflibercept injections administered in the loading phase. The 3+PRN group comprised 27 patients, whereas the 5+PRN group comprised 33 patients. The visual and anatomical outcomes were compared between the two groups at baseline and at 3, 6, 9, and 12 months. Results: Both 3+PRN and 5+PRN, showed statistically significant improvements in the best-corrected visual acuity and central macular thicknesse throughout the study period (p<0.001 and, p<0.001, respectively). There were no significant differences between the two groups in terms of changes in the best-corrected visual acuity and central macular thickness (p=0.453 and, p=0.784, respectively). The mean number of intravitreal aflibercept injections was significantly greater in the 5+PRN group (6.1 ± 0.8) than in the 3+PRN group (3.9 ± 0.8) (p<0.001). Conclusion: The 3+PRN and 5+PRN regimens showed similar 12-month visual and anatomical outcomes following treatment with intravitreal aflibercept injections in patients with macular edema.
RESUMO Objetivo: Comparar a eficácia de três injeções intravítreas mensais iniciais de aflibercept, seguidas de dosagem de pro re nata (3+PRN) versus cinco injeções mensais iniciais intravítreas de aflibercept, seguidas de doses de pro re nata (5 + PRN) em pacientes com edema macular diabético. Métodos: Foram analisados neste estudo retrospectivo e comparativo 60 pacientes que não receberam tratamento prévio com edema macular e foram submetidos a injeções intravítreas de aflibercept (2 mg/0,05 mL) com pelo menos um ano de acompanhamento. Os pacientes foram divididos em dois grupos de acordo com o número de injeções intravítreas de aflibercept administradas na fase inicial. O grupo 3+PRN compreendeu 27 pacientes, enquanto o grupo 5+PRN compreendeu 33 pacientes. Os resultados visuais e anatômicos foram comparados entre os dois grupos no período inicial e aos 3, 6, 9 e 12 meses. Resultados: Tanto os grupos 3+PRN quanto 5+PRN mostraram melhoras estatisticamente significativas na acuidade visual melhor corrigida e na espessura macular central ao longo do período de estudo (p<0,001 e p <0,001, respectivamente). Não houve diferenças significativas entre os dois grupos em termos de alterações na acuidade visual melhor corrigida e na espessura macular central (p=0,453 e p=0,784, respectivamente). O número médio de injeções intravítreas de aflibercept foi significativamente maior no grupo 5+PRN (6,1 ± 0,8) do que no grupo 3+PRN (3,9 ± 0,8) (p <0,001). Conclusão: Os regimes 3+PRN e 5+PRN mostraram resultados visuais e anatômicos semelhantes em 12 meses após o tratamento com injeções intravítreas de aflibercept em pacientes com edema macular.
Subject(s)
Humans , Recombinant Fusion Proteins , Macular Edema , Angiogenesis Inhibitors , Receptors, Vascular Endothelial Growth Factor , Diabetes Mellitus , Diabetic Retinopathy , Recombinant Fusion Proteins/administration & dosage , Visual Acuity , Macular Edema/drug therapy , Retrospective Studies , Treatment Outcome , Angiogenesis Inhibitors/administration & dosage , Receptors, Vascular Endothelial Growth Factor/administration & dosage , Diabetic Retinopathy/complications , Diabetic Retinopathy/drug therapy , Intravitreal Injections , Ranibizumab/therapeutic useABSTRACT
@#AIM: To compare of intravitreal bevacizumab and intravitreal bevacizumab and triamcinolone acetonide in eyes with bilateral diabetic macular edema.<p>METHODS: In this retrospective comparative-randomized study, 42 eyes of 21 diabetic patients with bilateral macular edema were evaluated. In one eye intravitreal injection of 1.25 mg bevacizumab(IVB group)was performed and in the fellow eye intravitreal injection of combined 1.25 mg bevacizumab and 1 mg triamcinolone acetonide(IVTA-IVB group)was performed. Main outcomes were the central macular thickness(CMT)measured with optical coherence tomography(OCT), ETDRS visual acuity(VA)and intraocular pressure(IOP).<p>RESULTS: Mean follow-up time was 4.7±1.5mo. In the IVB and IVTA-IVB groups, mean CMT was 494.7±114.4 μm and 546.8±165.6 μm before injections; 430.4±133.2 μm and 363.7±105.3 μm in first month; 484.8±167.4 μm and 407.3±108.7 μm in 3<sup>rd</sup> month; 550.4±191.5 μm and 516.8±158 μm after 6mo respectively. Differences were significant in first and 3<sup>rd</sup> months(<i>P</i><0.05). In the IVB and IVTA-IVB groups, mean ETDRS VA score was 57.1±13.5 and 48.9±13.9 before injections; 62.2±14 and 58.8±12.1 in first month; 59±13.7 and 59.3±13.6 in 3<sup>rd</sup> month; 55.6±14.9 and 55.5±8.7 after 6mo respectively. Differences were significant in first and 3<sup>rd </sup>and 6mo(<i>P</i><0.05). There was no IOP difference. IVTA-IVB group gains best VA in 3<sup>rd</sup> month after the first injection and maintains it for 6mo whereas IVB group gains best VA at first month and can be able to maintain for 3mo.<p>CONCLUSION: Injection of 1 mg IVTA-IVB seems to be better than IVB alone in improving VA for 6mo without any steroid dependent complications.