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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 Publisher Pubmed



Ahmadieh H1 ; Nourinia R2 ; Hafezimoghadam A3, 4 ; Sabbaghi H5 ; Nakao S3, 4, 6 ; Zandi S3, 4, 7 ; Yaseri M1, 8 ; Tofighi Z1 ; Akbarian S1
Authors
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Authors Affiliations
  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, MA, United States
  4. 4. Department of Radiology, Harvard Medical School, Boston, MA, United States
  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

Source: British Journal of Ophthalmology Published:2019


Abstract

Click here to listen to the Podcast 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. © Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.
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