Abstract
Objectives of the Study Summary of observational studies concerning the pharmacological management of diabetic macular edema (DME). Methods A literature review was conducted using the PubMed database on 1 February 2018 to identify studies evaluating the efficacy of anti-VEGF and dexamethasone (DEX) implants for DME. Studies with more than 10 patients and follow-up of more than 6 months were selected. Analyses were carried out on the overall population and on subgroups defined according to baseline visual acuity (BVA) and the patients' naïve or non-naïve status. Results Thirty-two studies evaluating the efficacy of anti-VEGF and 31 studies evaluating the efficacy of DEX-implants were retained, concerning 6,842 and 1,703 eyes, respectively. A mean gain of +4.7 letters for a mean of 5.8 injections (mean follow-up: 15.6 months) and +9.6 letters for a mean of 1.6 injections (10.3 months) was found in the anti-VEGF and DEX-implant studies, respectively. Final VA appears to be similar for both treatment (62 letters for anti-VEGF, 61.2 letters for DEX-implant), and BVA appears lower for DEX-implant, which may partially explain the greater visual gain. The DEX-implant studies show greater gains in VA compared to the anti-VEGF studies, especially for higher BVA. Indeed, mean gains for the subgroups of patients with BVA<50 letters, 50<BVA<60 letters, and BVA>60 letters are +4.3, +5.8, and +3.1 letters, respectively, in the anti-VEGF studies and +10.5, +9.3, and +8.8 letters, respectively, in the DEX-implant studies. Regarding the patient's initial status, only naïve status appears to confer the best functional response in DEX-implant studies. Conclusion Observational studies investigating DEX-implant report clinically similar final VA when compared to anti-VEGF, but superior visual gains in real-life practice. This latter difference could be due to the better BVA, but also to the fact that less injections were administered in the anti-VEGF observational studies than in the interventional studies.
Highlights
Diabetic macular edema (DME) is one of the clinical manifestations of diabetic retinopathy (DR)
Laser photocoagulation [6] was the standard treatment for patients with clinically significant diabetic macular edema (DME), leaving macular scars that increase in size over time and can cause secondary vision loss [7]
If different anti-VEGF drugs were used or different types of patients included, we presented the results separated into different groups of treatment
Summary
Diabetic macular edema (DME) is one of the clinical manifestations of diabetic retinopathy (DR). Ranibizumab, aflibercept, and the DEX-implant have been granted European Marketing Authorization (EMA) worldwide for this indication, but this is not the case for bevacizumab This authorization was obtained based on the data from the pivotal interventional studies. Findings based on a strictly selected patient population cannot be extrapolated to a broader panel of unselected patients This is a major problem when treatment guidelines are intended for use in routine practice. These randomized, controlled studies, with their necessarily stringent inclusion and exclusion criteria, do not obtain data on patients with very high or very low baseline visual acuity (BVA) or with certain comorbidities or on non-naıve patients. It is vital to consider a significant number of real-life studies, in order to draw valid conclusions
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
