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Ophthalmology 2016
November 21-23, 2016
November 21-23, 2016 Dubai, UAE
10th International Conference on
Clinical & Experimental Ophthalmology
Volume 7 Issue 9 (Suppl) J Clin Exp Ophthalmol
ISSN: 2155-9570 JCEO, an open access journal
Bevacizumab monotherapy or combined with laser versus laser monotherapy in Mongolian patients
with diabetic macular edema
Anaraa Toishubai1, Uranchimeg Davaatseren 2, Sun Taek Lim3, Baasankhuu Jamyanjav 2, Bulgan Tuvaan2, Munkhzaya Tsengenbayar1, Munkhkhishig Batbileg4,
Oyunzaya Luvsantseren4, Urangua Jamyansuren4, Munkhsaikhan Munkhkhuyag5, Chimidsuren Ochir2, Unurtsetseg Chandaga2 and Yerkyebulan Mukhtar2
1Third Central State Hospital, Mongolia
2Mongolian National University of Medical Sciences, Mongolia
3Eye choice LST Eye Clinic, South Korea
4Infinity Eye Clinic, Mongolia
5Bolor Melmii Eye Clinic, Mongolia
Objectives: To evaluate the efficacy and safety of bevacizumab monotherapy or combined with laser versus laser monotherapy in
Mongolian patients with visual impairment due to diabetic macular edema.
Design: Prospective, randomized, single-center, a 12 month, laser-controlled, clinical trial.
Participants: One hundred twelve patients aged ≥18 years, with type 1 or 2 diabetes mellitus and best corrected visual acuity (BCVA)
in the study eye of 35 to 69 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 4m (Snellen equivalent: 6/60 or 6/12), with
visual impairment due to center-involved diabetic macular edema (DME).
Methods: Patients were randomized to one of the three treatment arms: intra-vitreal bevacizumab (n=42), and intra-vitreal
bevacizumab with laser (n=35), or laser alone (n=35). Bevacizumab injections were given for 3 initial monthly doses and then pro
re nata (PRN) thereafter based on BCVA stability and DME progression. Laser photocoagulation was given at baseline then PRN as
per ETDRS guidelines.
Main Outcome Measures: Average change in BCVA from baseline to months 1 through 12, central subfield thickness (CST) and
safety over 12 months.
Results: Bevacizumab monotherapy or combined with laser were superior to laser monotherapy in improving mean change in BCVA
letter score from baseline to months 1 through 12 (+8.3 and +11.3 vs. +0.06 letters; both p<0.0001). Although the improvement
was greater with bevacizumab combined with laser than with the other two arms (p<0.0001 for bevacizumab combined with laser
vs. laser monotherapy and p<0.006 for bevacizumab combined with laser vs. bevacizumab monotherapy). At month 12, greater
proportion of patients gained ≥10 and ≥15 letters and with BCVA letter score >73 with bevacizumab monotherapy (23.8% and 7.1%
and 4.8%, respectively) and bevacizumab + laser (57.1% and 28.6% and 14.3%, respectively) versus laser monotherapy (0% and 0%
and 0%). The mean central subfield thickness was significantly reduced from baseline to month 12 with bevacizumab (−124.4 μm)
and bevacizumab + laser (−129.0 μm) versus laser (−62.0 μm; both p<0.002). Patients received a mean of 8.1 and 6.3 bevacizumab
injections in the bevacizumab and bevacizumab + laser arms. Conjunctival hemorrhage was the most common ocular events. No
endophthalmitis cases occurred. Bevacizumab monotherapy or combined with laser was not associated with an increased risk of
cardiovascular or cerebrovascular events in this study.
Conclusion: Bevacizumab monotherapy or combined with laser showed superior BCVA improvements over macular laser treatment
alone in Mongolian patients with visual impairment due to diabetic macular edema.
J Clin Exp Ophthalmol 2016, 7:9(Suppl)