Das diabetische Makulaödem - Patientenkollektiv und Behandlungsrealität in einem Universitätsklinikum

Diabetic macular edema is an ocular disease that is often followed by vision loss. The current standard of care is treatment with intravitreal VEGF-inhibitors. As a second-line treatment long-acting corticosteroids can be used. To date, the efficiency of these two treatments has mostly been demonstrated in randomized controlled trials. Real-world studies aimed to represent clinical practice as realis-tically as possible, but even these studies often applied strict in- and exclusion criteria regarding the analysed patients. Therefore, the aim of this study was to represent the real-world clinical experi-ences regarding patient population and treatment of diabetic macular edema at a university clinic in Germany as accurately as possible. Data from 176 eyes of 114 patients diagnosed with diabetic macular edema who were treated with at least one intravitreal injection in 2018 at the Department of Ophthalmology at the university clinic of Marburg was retrospectively analysed. For each eye the following variables were collected and analysed: gender (fe-male/male), age [years], HbA1c value [%], pretreatment regarding diabetic macular edema (none, intravitreal injection, laser, pars plana vitrectomy), received intravitreal injections during the analysed period including used medication and date as well as focal laser treatments and pars plana vitrectomy. Furthermore, visual acuity measurements [LogMAR] and central retinal thickness-values [μm] before and after the treatment were documented. Conducting multiple linear regression analyses we defined change in visual acuity [LogMAR], change in central retinal thickness [μm] and number of injections as the dependent variables. The influence of the different variables on each dependent variable has been investigated while also taking into account the interactions between the inde-pendent variables themselves. Patients were predominantly male (61,93 %), the median age was 67 years, the median HbA1c-value was 7 % and most eyes were already pretreated regarding their diabetic macula edema (71,59 %). The median baseline visual acuity was 0,40 LogMAR, the median baseline central retinal thickness was 331 μm. During the study a total of 688 intravitreal injections was registered (644 anti-VEGF, 44 steroids). The median was three injections per eye. Furthermore, 14 eyes received focal laser treatment and six eyes underwent pars plana vitrectomy because of their diabetic macular edema. Regarding the developmet of visual acuity and central retinal thickness over the course of the study an improvement in visual acuity of 0,04 LogMAR and a reduction in central retinal thickness of 44,54 μm were observed. These analyses refer to 147 and 142 eyes of whom a visual acuity value or a value of the central retinal thickness before and after the treatment could be obtained. The results show that patients received a remarkably lower number of injections than patients in randomized controlled trials. Also the mean visual gain and the mean reduction in retinal thickness was lower than in these studies which confirms data from other real-world studies. Subgroup analyses were also performed. A statistically significant influence of the administered intravitreal drug on the development of visual acuity or central retinal thickness could not be found. However, there was a significant influence of baseline visual acuity on the development of visual acuity: the group of eyes with worse baseline visual acuity showed a significantly greater increase in visual acuity than those with better baseline visual acuity. Moreover, an association between baseline central retinal thickness and its development during the study was discovered: The group of eyes with a thicker baseline central retinal thickness experienced a greater reduction than eyes with a thinner baseline central retinal thickness. This association was statistically sig-nificant and confirmed by the regression analysis as well. The multiple linear re-gression analyses that were performed also showed that pre-treatment with intravitreal injections was associated with a higher number of injections in the fur-ther course of the study compared to no pretreatment. Eyes that had been treated with intravitreal injections in the past needed more injections. To the best of our knowledge, this has not been described in the literature to date. In conclusion, this study accomplished to demonstrate treatment reality of patients suffering from diabetic macular edema treated at a university clinic in Germany as accurately as possible.