Рандомизированное исследование, сравнивающее интравитреальный бевацизумаб и фокусную лазерную фотокоагуляцию при диабетической макулопатии

Тойшубай Анараа; Даваацэрэн Уранчимэг; Жамьяанжав Баасанхуу; Сун Тэк Лим; Цэнгэнбаяр Мунхзаяа; Батбилэг Мунххишиг; Лувсанцэрэн Оюунзаяа; Жамьяансурэн Урангуа; Нанжид Худэрчулуун; Хасаг Алтайсайхан

Тойшубай Анараа Sondra Eye Clinic, Ulaanbaatar, Mongolia http://orcid.org/0000-0001-8485-2961
Даваацэрэн Уранчимэг Mongolian National University of Medical Science, Ulaanbaatar, Mongolia http://orcid.org/0000-0002-5860-1947
Жамьяанжав Баасанхуу Bolor Melmii Eye Hospital, Ulaanbaatar, Mongolia http://orcid.org/0000-0002-7062-5503
Сун Тэк Лим Paransae Eye Hospital, Gwangju, South Korea http://orcid.org/0000-0001-6047-4177
Цэнгэнбаяр Мунхзаяа Sondra Eye Clinic, Ulaanbaatar, Mongolia http://orcid.org/0000-0003-2427-7437
Батбилэг Мунххишиг Sondra Eye Clinic, Ulaanbaatar, Mongolia http://orcid.org/0000-0001-5101-649X
Лувсанцэрэн Оюунзаяа Sondra Eye Clinic, Ulaanbaatar, Mongolia http://orcid.org/0000-0003-0299-2165
Жамьяансурэн Урангуа Sondra Eye Clinic, Ulaanbaatar, Mongolia http://orcid.org/0000-0002-5028-1889
Нанжид Худэрчулуун Mongolian National University of Medical Science, Ulaanbaatar, Mongolia http://orcid.org/0000-0001-7699-2649
Хасаг Алтайсайхан Mongolian National University of Medical Science, Ulaanbaatar, Mongolia http://orcid.org/0000-0002-7014-1883

Abstract

Aim. To evaluate the efficacy and safety of bevacizumab monotherapy or bevacizumab combined with focal/grid laser compared with focal/grid laser alone for treatment of diabetic macular edema (DME).

Methods. One hundred twelve eligible patients, aged ≥18 years, with type 1 or 2 diabetes mellitus and best correctedvisual acuity (BCVA) in the study eye of 35 to 69 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 4 m (Snellenequivalent: ≥6/60 or ≤6/12), with visual impairment due to center-involved diabetic macular edema (DME). Patients wererandomized into three treatment groups: (I) intravitreal bevacizumab monotherapy (n=42), (II) intravitreal bevacizumabcombined with laser (n=35), (III) laser monotherapy (n=35). Bevacizumab injections were given for 3 initial monthly dosesand then pro re nata (PRN) thereafter based on BCVA stability and DME progression. The primary efficacy endpoints werethe meanchange in BCVA and central retinal subfield thickness (CRST) from baseline to month 12.

Results. Bevacizumab monotherapy or bevacizumab + laser were superior to laser monotherapy in improving the meanchange in BCVA letter score from baseline to month 12 (+8.3 and +11.3 vs +1.1 letters; both p<0.0001). At month 12, agreater proportion of patients gained ≥10 and ≥15 letters and with BCVA letter score >73 (Snellen equivalent: >6/12) withbevacizumab 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 retinal subfield thickness was significantlyreduced from baseline to month 12 with bevacizumab (-124.4 μm) and bevacizumab + laser (-129.0 μm) versus laser (-62.0μm; both p=0.002). Conjunctival hemorrhage was the most common ocular events. No endophthalmitis cases occurred.

Conclusion. Bevacizumab monotherapy or bevacizumab + laser showed superior BCVA improvements over macularlaser treatment alone in Mongolian patients with visual impairment due to diabetic macular edema.

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A randomized trial comparing intravitreal bevacizumab and focal laser photocoagulation for diabetic macular edema

Abstract

References