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Bevacizumab versus triamcinolone for persistent diabetic macular edema: a randomized clinical trial

  • Retinal Disorders
  • Published:
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Abstract

Purpose

To evaluate 24-week visual acuity and anatomic outcomes of two “pro re nata” (prn) treatment strategies (intravitreal bevacizumab [IVB] prn versus intravitreal triamcinolone acetonide [IVT] prn) in patients with persistent diabetic macular edema (pDME) after 24 weeks of prn-IVB.

Methods

One hundred eyes with center-involving DME were enrolled and treated with prn-IVB for 24 weeks; at week 24, eyes with pDME (central subfield thickness [CST] on spectral domain optical coherence tomography > 300 μm) were randomized to IVB monthly prn (group I; prn-IVB) or IVT every 3 months prn (group II; prn-IVT) and eyes in which the CST was ≤ 300 μm were assigned to continue prn-IVB (group III).

Results

Seventy-four eyes completed a 48-week study period. At week 24, 65 (79.3%) eyes still had DME with CST > 300 μm and, therefore, were randomized to prn-IVB (group I, n = 33) or prn-IVT (group II, n = 32); the remaining 17 (20.7%) eyes had CST ≤ 300 μm and were assigned to continued treatment with prn-IVB (group III). At baseline, mean CST (μm) ± standard error of the mean (SEM) was 447.2 ± 24.4, 478.0 ± 19.7, and 386.0 ± 21.0 in groups I, II, and III, respectively (p > 0.05). At week 48, there was no significant difference in mean CST between groups I and II (369.9 ± 23.3 and 426.0 ± 26.1, respectively; p = 0.9995). A significant reduction in mean CST, compared with baseline, was noted at weeks 28 (p = 0.0002) and 44 (p = 0.0002) in group II. Group I did not show a significant reduction in mean CST compared with baseline at any study visit. There were no significant differences in mean CST between groups I and II at any study visit. At baseline, mean ± SEM best-corrected visual acuity (BCVA) (logMAR) was 0.50 ± 0.00, 0.60 ± 0.10, and 0.50 ± 0.10 in groups I, II, and III, respectively (p > 0.05). At week 48, there was no statistically significant difference in mean BCVA between groups I and II (0.50 ± 0.10 and 0.80 ± 0.10, respectively; p = 0.4473). There was no significant improvement in mean BCVA, as compared with baseline, at any study follow-up visit in any of the groups. Group II demonstrated significantly lower BCVA after 24 weeks of IVT (at week 48) compared with baseline (p = 0.0435). There was no significant difference in mean BCVA between groups I and II at any time-point.

Conclusion

In eyes with pDME after 24 weeks of treatment with prn-IVB, there was no difference between continued treatment with prn-IVB versus a treatment switch to prn-IVT with respect to mean BCVA or mean CST at week 48. However, BCVA was stable in the prn-IVB group, while prn-IVT was associated with BCVA reduction from baseline and a higher risk of IOP elevation.

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Acknowledgments

We thank Ms. Lucélia Albieri (ophthalmic technician and patient advisor) from University of São Paulo (Brazil) for image acquisition and patient counseling.

Contributors

JAC and RJ are the primary contributors to the research design. MWR is responsible for research execution and data acquisition. AM is the primary contributor to data analysis. Manuscript preparation by MWR with revisions and interpretation was provided by JAC, RCS, IUS, and RJ.

Funding

The project had financial support by CNPq government (National Research Council) grant number 142177/2016-4.

Author information

Authors and Affiliations

  1. Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, Brazil, 3900, Bandeirantes av., Campus, 12fl., Ribeirão Preto, São Paulo, 14048-900, Brazil

    Murilo W. Rodrigues, José A. Cardillo, André Messias, Rubens C. Siqueira & Rodrigo Jorge

  2. Departments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, 700 HMC Crescent Road, Hershey, PA, 17033, USA

    Ingrid U. Scott

Authors
  1. Murilo W. Rodrigues
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  2. José A. Cardillo
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Correspondence to Murilo W. Rodrigues.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the Ribeirão Preto Medical School at University of São Paulo and with the 1964 Declaration of Helsinki and its later amendments.

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Informed consent was obtained from all individual participants included in the study.

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Electronic supplementary material

S. Figure 1.

Diamond graphs merge the mean distribution of number injections in each group (I, II and III) after 48 weeks of treatment. The individual total number of injections was higher (P<0.001) in group I: (mean ± SE) 11.3 ± 0.4 than in group II: 8.2 ± 0.3, and both were greater than (P<0.001) in group III: 5.1 ± 0.8 (ANOVA followed by all pairs Tukey-Kramer HSD). (JP2 785 kb)

S. Figure 2.

Optical coherence tomography from Group I patients at Baseline, 24-week and 48-week study periods. Different architectural changes were verified. CME was verified in Cases N2, N7, N16 and N23. Cases N2 and N7 presented DRIL. Hyperrefllective plaques were found in case N7. Hyperreflective foci were seen in cases N2, N7, N23 and N42. Ellipsoid/ELM attenuation was seen in cases N2, N7, N16, N23. Progressive SRD was presented in case N16. (JP2 940 kb)

S. Figure 3.

Optical coherence tomography from Group II patients at Baseline, 24-week and 48-week study periods. Different architectural changes were verified. CME was verified in Cases N22, N24, N33, N35 and N44. Case N1 presented DRIL. Hyperrefllective foci and/or exsudates were found in cases N1, N24, N33, N34, N35 and N44. Ellipsoid/ELM attenuation was seen in cases N22, N24, N33, N34, N35 and N44. SRD were presented in cases N22, N24, N33, N34 and N35. Case N44 presented progressive SRD. (JP2 457 kb)

S. Figure 4.

Optical coherence tomography from Group I patients at Baseline, 24-week and 48-week study periods. Different architectural changes were verified. CME was verified in Cases N28, N38, and N40. Cases N13 and N26 presented DRIL. Hyperrefllective foci and/or exsudates were found in cases N13 and N26. Hyperrefllective plaque was showed in case N26. Ellipsoid/ELM attenuation was seen in cases N26 and N40. (JP2 510 kb)

S. Table 1.

Number of injections. (DOCX 13 kb)

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Rodrigues, M.W., Cardillo, J.A., Messias, A. et al. Bevacizumab versus triamcinolone for persistent diabetic macular edema: a randomized clinical trial. Graefes Arch Clin Exp Ophthalmol 258, 479–490 (2020). https://doi.org/10.1007/s00417-019-04564-z

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