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Br J Ophthalmol. 2019 Jul;103(7):922-927. doi: 10.1136/bjophthalmol-2018-312244. Epub 2018 Aug 27.

Intravitreal injection of a Rho-kinase inhibitor (fasudil) combined with bevacizumab versus bevacizumab monotherapy for diabetic macular oedema: a pilot randomised clinical trial.

Author information

1
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran hahmadieh@hotmail.com.
2
Ocular Tissue Engineering Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
3
Molecular Biomarkers Nono-Imaging Laboratory, Brigham and Women's Hospital, Boston, Massachusetts, USA.
4
Department of Radiology, Harvard Medical School, Boston, Massachusetts, USA.
5
Ophthalmic Epidemiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
6
Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University, Kyushu, Japan.
7
Berner Augenklinik am Lindenhofspital, Swiss Eye Institute and Clinic for Vitreoretinal Diseases, Bern, Switzerland.
8
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
9
Department of Epidemiology and Biostatistics, Tehran University of Medical Sciences, Tehran, Iran.
#
Contributed equally

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.

KEYWORDS:

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

[Indexed for MEDLINE]

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