Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2020 Sep-Oct;83(5):396-401.
doi: 10.5935/0004-2749.20200078.

Three versus five intravitreal aflibercept injections as the initial loading phase in the treatment of diabetic macular edema: one-year results

Akin Cakir  1 , Burak Erden  1 , Selim Bolukbasi  1 , Ozkan Sever  2 , Sezin Ozdogan Erkul  3 , Ozen Ayranci Osmanbasoglu  3 , Gulderen Karaca  1 , Mustafa Nuri Elcioglu  1
Affiliations
Clinical Trial

Three versus five intravitreal aflibercept injections as the initial loading phase in the treatment of diabetic macular edema: one-year results

Akin Cakir et al. Arq Bras Oftalmol. 2020 Sep-Oct.

Abstract
in English, Portuguese

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.

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.

PubMed Disclaimer

Conflict of interest statement

Disclosure of potential conflicts of interest: None of the authors have any potential conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Mean change in CMT from baseline through year 1.
Figure 2
Figure 2
Mean change in BCVA in logMAR from baseline through year 1.
Figure 3
Figure 3
Proportions of eyes that gained ≥10 and ≥15 letters from baseline to year 1.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Schmidt-Erfurth U, Garcia-Arumi J, Bandello F, Berg K, Chakravarthy U, Gerendas BS, et al. Guidelines for the management of diabetic macular edema by the European Society of Retina Specialists (EURETINA) Ophthalmologica. 2017;237(4):185–222. - PubMed
    1. Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. IV. Diabetic macular edema. Ophthalmology. 1984;91(12):1464–1474. - PubMed
    1. Panozzo G, Staurenghi G, Dalla Mura G, Giannarelli D, Alessio G, Alongi S, et al. Prevalence of diabetes and diabetic macular edema in patients undergoing senile cataract surgery in Italy: The Diabetes and Cataract study. Eur J Ophthalmol. 2019:1120672119830578. [Epub ahead of print] - PMC - PubMed
    1. Ashraf M, Souka A, Adelman R, Forster SH. Aflibercept in diabetic macular edema: evaluating efficacy as a primary and secondary therapeutic option. Eye (Lond) 2016;30(12):1531–1541. Comment in: Eye (Lond). 2017;31(12):342-5. Eye (Lond). 2017;31(12):342. - PMC - PubMed
    1. Mitchell P, Bandello F, Schmidt-Erfurth U, Lang GE, Massin P, Schlingemann RO, Sutter F, Simader C, Burian G, Gerstner O, Weichselberger A, RESTORE study group The RESTORE study: ran ibizumab monotherapy or combined with laser versus laser mon otherapy for diabetic macular edema. Ophthalmology. 2011;118(4):615–625. - PubMed

Publication types

MeSH terms