Anti-vascular endothelial growth factor therapy in diabetic macular edema: real-life outcomes from a multicenter study in Turkey over 36 months

Abstract

Purpose: This study aimed to report the visual and anatomical outcomes of intravitreal anti-VEGF treatment for diabetic macular edema (DME) in a real-world clinical setting from Turkey over 36 months.Methods: This is a retrospective, multicenter (7 cites) study. The medical records of 1072 eyes (both previously treated and naive eyes) of 706 consecutive patients with visual impairment due to centerinvolving DME treated with intravitreal anti-VEGF injections between April 2007 and February 2017, were reviewed. The eyes were divided into mutually exclusive three groups based on the duration of follow-up (12, 24, or 36 months). Primary outcome measures were changes in visual acuity (VA) and central macular thickness (CMT) from baseline to nal visit in each cohort, frequency of visits, and intravitreal anti-VEGF injections. As secondary endpoints, VA outcomes were assessed in subgroups strati ed by baseline VA [<70 ETDRS letters and ≥ 70 ETDRS letters] and loading dose status of anti-VEGF injections.Results: VA increased by a mean of 8.2 letters (12-month cohort, p<0.001), 5.3 letters (24-month cohort, p<0.001), and 4.4 letters (36-month cohort, p=0.017) at nal visits. The eyes with <70 VA letters achieved more signi cant VA improvement at nal visits in all cohorts compared with eyes with >70 VA letters (p<0.001). The mean decreases in CMT from baseline to last visits at 12-, 24-, and 36-month cohorts were -100.5, -107.7, and -114.3 µm, respectively (p<0.001). The mean number of injections given were 4.6, 2.3, and 1.8 during years 1 to 3, respectively. Patients who received loading dose showed greater VA gains than those who did not in all follow-up cohorts. Conclusion:Our study revealed that anti-VEGF treatment improved VA and CMT over a follow-up of 36 months. Although these real-life VA outcomes following anti-VEGF therapy for DME were similar to other real-life studies, they were inferior to those noted in randomized controlled trials, mainly due to undertreatment.

Real-World Outcomes of Intravitreal Anti-Vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema in Türkiye: MARMASIA Study Group Report No. 1

“…However, better mean letter gains were observed in our 24- and 36-month cohorts (8.6 and 8.4, respectively), as well as better CMT reductions in all our cohorts. This discrepancy in BCVA gains could have resulted from Durukan et al 27 excluding the eyes with visual acuity worse than 20/400 Snellen, resulting in a mean overall baseline BCVA of 55.6 letters, which is higher than ours. Also, although they stated that there were no significant differences in BCVA gains of the cohorts at any time, another reason could be the mutually exclusive nature of the cohort groups and adjunctive therapies the patients received, since there were also smaller reductions in CMT from baseline, especially at 24 and 36 months.…”

“…Recently, Durukan et al 27 published the first large-scale RWE study of DME treatment from the Central Anatolia region of Türkiye, reporting a similar lower number of injections and gains like other RWE studies on DME. Therefore, we established a multicenter collaboration to further evaluate the real-world outcomes of intravitreal anti-VEGF treatment of DME in 8 tertiary reference centers located on the ASIAn side of the MARMara region of Türkiye (MARMASIA Study Group).…”

“… 45 , 46 , 47 , 48 Numerous prospective and retrospective RWE studies involving these patients have provided complementary information about the effectiveness of intravitreal anti-VEGF agents on DME, particularly emphasizing the importance of number of follow-ups and injections to avoid undertreatment. 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 …”

“…Recently, Durukan et al 27 reported +8.3, +5.3, and +4.4 mean letter gains and -105.5, -107.7, and -114.3 µm CMT reductions compared to baseline with a mean of 4.6±2.0, 2.3±1.9, and 1.8±1.8 anti-VEGF IVIs per year in mutually exclusive groups of DME patients from Türkiye followed up for 12, 24, and 36 months, respectively. Those findings align with our results regarding IVI numbers of all cohorts and mean letter gains in the first year (8.0).…”

“… 16 Also, several RWE studies, even systematic reviews and meta-analyses, report anatomical and functional effectiveness of anti-VEGF agents in DME but with less impressive results than in RCTs, mainly due to undertreatment, less frequent monitoring, and lower patient compliance. 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 …”