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Intravitreal diclofenac versus intravitreal bevacizumab in naive diabetic macular edema: a randomized double-masked clinical trial

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Abstract

The purpose of the study is to compare single injection of intravitreal diclofenac (IVD) with intravitreal bevacizumab (IVB) in the treatment of eyes with naïve diabetic macular edema (DME). In this randomized clinical trial, 57 eyes of 57 patients were randomly assigned to IVD group (30 eyes), cases who received a single intravitreal injection of diclofenac (500 μg/0.1 ml), and IVB group (27 eyes), cases who received a single intravitreal injection of bevacizumab (1.25 mg). Change in best-corrected visual acuity in logMAR at week 12 was the primary outcome measure. Secondary outcomes included changes in central macular thickness, macular leakage, and potential injection-related complications. Best-corrected visual acuity improved significantly more in the IVD group than in the IVB group (P = 0.033), from 0.57 ± 0.25 to 0.49 ± 0.31 versus 0.55 ± 0.24–0.59 ± 0.27 logMAR at 12 weeks, respectively. However, the difference of macular thickness changes was in favor of IVB, but not to a significant level. The amount of change in leakage was not significantly different between the groups either. None of the eyes, in either group, developed ocular hypertension (≥23 mmHg) or cataract progression. No important injection-related complication was observed during the study period. This study demonstrated the superiority of IVD over IVB in the treatment of naïve DME regarding functional, but not anatomical outcomes. Therefore, using IVD as an adjunct or even alternative to other treatments might enhance the functional outcomes in such cases. Further studies are warranted to confirm potential benefit of IVD observed in this study.

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Acknowledgments

This study supported by Ophthalmic Research Center of Shahid Beheshti University (MC) Tehran, Iran.

Disclosures

The authors have no proprietary or commercial interest in any material discussed in this article.

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Authors and Affiliations

  1. Ophthalmology Department and Ophthalmic Research Center, Labbafinejad Medical Center, Shahid Beheshti Medical University of Medical Sciences, Pasdaran Ave. Boostan 9 St., 16666, Tehran, Iran

    Masoud Soheilian, Saeed Karimi, Alireza Ramezani, Talieh Montahai, Mehdi Yaseri & Roham Soheilian

  2. Negah Eye Hospital, Tehran, Iran

    Masoud Soheilian & Alireza Ramezani

  3. Imam Hossein Medical Center, Tehran, Iran

    Alireza Ramezani

  4. Department of Basic Medical Sciences, University of Arizona Health Science Center, Phoenix, AZ, USA

    Gholam A. Peyman

Authors
  1. Masoud Soheilian
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  2. Saeed Karimi
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  3. Alireza Ramezani
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  4. Talieh Montahai
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  5. Mehdi Yaseri
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  6. Roham Soheilian
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  7. Gholam A. Peyman
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Correspondence to Masoud Soheilian.

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Soheilian, M., Karimi, S., Ramezani, A. et al. Intravitreal diclofenac versus intravitreal bevacizumab in naive diabetic macular edema: a randomized double-masked clinical trial. Int Ophthalmol 35, 421–428 (2015). https://doi.org/10.1007/s10792-014-9967-z

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  • DOI: https://doi.org/10.1007/s10792-014-9967-z

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