Combination of intravitreal Bevacizumab and Erythropoietin versus intravitreal bevacizumab alone for refractory diabetic macular edema; a randomized double-blind clinical trial

سال انتشار: 1398
نوع سند: مقاله کنفرانسی
زبان: انگلیسی
مشاهده: 441

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شناسه ملی سند علمی:

ACSOMED29_039

تاریخ نمایه سازی: 30 آذر 1398

چکیده مقاله:

Purpose: To evaluate the effect of three intravitreal bevacizumab (IVB) injection alone or in combination with intravitreal erythropoietin (EPO) in the treatment of refractory diabetic macular edema (DME). Methods: In a randomized double-blind clinical trial, 48 eyes of 34 diabetic patients with refractory DME were enrolled. Eyes were randomly assigned to receive either 3 monthly injections of 0.05 cc (1.25mg) IVB plus 0.05 cc (1000 Unit) EPO or 0.05 cc (1.25mg) IVB alone. Main outcome was best-corrected visual acuity (BCVA) changes and secondary outcome was central macular thickness (CMT). The patients were followed for 6 months. Results: Mean BCVA changes up to 4 and 6 months were insignificant in both groups. It changed from 0.72±0.56 logMAR at baseline to 0.74±0.5 (P=0.85) and 0.71±0.44 (P=0.40) in the combination group and from 0.48±0.39logMAR to 0.47±0.35 (P=0.48) and 0.52±0.33 (P=0.69) in the IVB alone group, at 4 and 6 months, respectively. The difference of mean BCVA changes between the groups were insignificant at both 4 and 6 months (P=0.07 and P=0.36, respectively). Within the group changes of mean CMT were significant only in the combination group at 4 and 6 months, from 518±134μ at baseline to 472±151 to 475±167μ, respectively (P=0.01 and P=0.05). Corresponding changes were not significant in the IVB alone group. However, the difference between the groups was not significant at all visits (P=0.51 and P=0.71, respectively). Conclusion: This clinical trial demonstrated that intravitreal erythropoietin had no additional effect to IVB in the treatment of refractory DME in short term.

نویسندگان

Morteza Entezari

Ophthalmic Research Center, Department of Ophthalmology, Imam Hossein Medical Center, Shahid Beheshti Medical Sciences, Tehran, Iran

Zahra Kiani Flavarjani

Ophthalmic Research Center, Department of Ophthalmology, Imam Hossein Medical Center, Shahid Beheshti Medical Sciences, Tehran, Iran

Alireza Ramezani

Ophthalmic Research Center, Department of Ophthalmology, Imam Hossein Medical Center, Shahid Beheshti Medical Sciences, Tehran, Iran

Humayon Nikkhah

Ophthalmic Research Center, Department of Ophthalmology, Imam Hossein Medical Center, Shahid Beheshti Medical Sciences, Tehran, Iran

Saeed Karimi

Ophthalmic Research Center, Department of Ophthalmology, Imam Hossein Medical Center, Shahid Beheshti Medical Sciences, Tehran, Iran

Hamid Fateh Moghadam

Ophthalmic Research Center, Department of Ophthalmology, Imam Hossein Medical Center, Shahid Beheshti Medical Sciences, Tehran, Iran