Article Text
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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