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Intravitreal injection of a Rho-kinase inhibitor (fasudil) combined with bevacizumab versus bevacizumab monotherapy for diabetic macular oedema: a pilot randomised clinical trial
  1. Hamid Ahmadieh1,
  2. Ramin Nourinia2,
  3. Ali Hafezi-Moghadam3,4,
  4. Hamideh Sabbaghi5,
  5. Shintaro Nakao3,4,6,
  6. Souska Zandi3,4,7,
  7. Mehdi Yaseri1,8,
  8. Zahra Tofighi1,
  9. Shadi Akbarian1
  1. 1 Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  2. 2 Ocular Tissue Engineering Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  3. 3 Molecular Biomarkers Nono-Imaging Laboratory, Brigham and Women's Hospital, Boston, Massachusetts, USA
  4. 4 Department of Radiology, Harvard Medical School, Boston, Massachusetts, USA
  5. 5 Ophthalmic Epidemiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  6. 6 Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University, Kyushu, Japan
  7. 7 Berner Augenklinik am Lindenhofspital, Swiss Eye Institute and Clinic for Vitreoretinal Diseases, Bern, Switzerland
  8. 8 Department of Epidemiology and Biostatistics, Tehran University of Medical Sciences, Tehran, Iran
  1. Correspondence to Professor Hamid Ahmadieh, Ophthalmic Research Center, Labbafinejad Medical Center, Tehran 16666, Iran; hahmadieh{at}hotmail.com

Abstract

Background/aims To compare the efficacy of combined intravitreal injection of bevacizumab and a Rho-kinase inhibitor, fasudil (intravitreal bevacizumab (IVB)/intravitreal fasudil (IVF)), with IVB alone for centre-involving diabetic macular oedema (DME).

Methods In this prospective randomised clinical trial, 44 eyes with centre-involving DME were randomised into two groups. The combined group received three consecutive injections of IVB (1.25 mg) and IVF (50 µM/L) monthly, while the monotherapy group received only one IVB (1.25 mg) injection per month for 3 months. Changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) were compared between the two groups at months 3 and 6. The primary outcome measure was the mean change in BCVA at month 6.

Results Mean BCVA was significantly improved in both groups at month 3 (P<0.001), but it persisted up to month 6 only in the IVB/IVF group. Improvement of BCVA was greater in the IVB/IVF group at both time points (P=0.008, P<0.001). In the IVB/IVF and IVB groups, 54.5% versus 10% of the eyes gained≥15 ETDRS letters at month 6 (P=0.026). Between months 3 and 6, mean BCVA significantly decreased by 5±7 ETDRS letters in the IVB group (P=0.002), while no significant deterioration was observed in the IVB/IVF group. Corresponding with the BCVA changes, CMT was significantly reduced in both groups at month 3 (p=0.006, p<0.001) but this reduction sustained only in the IVB/IVF group up to month 6 (p<0.001).

Conclusion Adjunctive intravitreal injection of a Rho-kinase inhibitor may enhance and prolong the therapeutic effects of anti-vascular endothelial growth factor drugs for centre- involving DME.

  • best corrected visual acuity
  • bevacizumab
  • central macular thickness
  • clinical trial
  • combined therapy
  • diabetic macular edema
  • fasudil
  • Rho-Kinase (ROCK) inhibitor

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Footnotes

  • HA and RN contributed equally.

  • Presented at This study was presented as a paper at the Retina Subspecialty Day and as a poster at the American Academy of Ophthalmology Annual Meeting, 2016, Chicago, USA.

  • Contributors HA, RN: design, acquisition and interpretation of data, drafting, revising and final approval of the manuscript. AH-M, SN and SZ: design, revising and final approval of the manuscript. HS: design, acquisition and interpretation of data, drafting and final approval of the manuscript. MY: design, analysis and interpretation of data and final approval of the manuscript. ZT: design, drafting, revising and final approval of the manuscript. SA: acquisition of data, drafting and final approval of the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval Ethics Committee, Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences (IR.SBMU.ORC.REC.1392.1).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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