Abstract
Purpose: This study evaluates if the addition of a curcumin formulation with a polyvinylpyrrolidone-hydrophilic carrier (CHC; Diabec®, Alfa Intes, Italy) to intravitreal injections of dexamethasone (DEX-IVT) can affect the morphological retinal characteristics, extending the steroid re-treatment period in patients with diabetic macular edema (DME). Methods: A randomized controlled clinical trial was carried out in DME patients, randomly assigned to receive DEX-IVT or DEX-IVT and a CHC. The evaluation of the mean difference of central retinal thickness (CRT) was the primary aim. Secondary aims were the evaluations of best-corrected visual acuity, differences in the predetermined retinal layer thickness, the number/time of re-treatment, and the assessment of safety. Results: A total of 73 DME patients were included (35 in the control group and 38 in the combined therapy group). In both the control and combined therapy groups, the mean CRT change from T0 to the 6 months’ evaluation was significant (p = 0.00). The mean CRT result was significantly different at month 4 (p = 0.01) between the control and combined therapy groups, with a greater reduction in the combined therapy group, in particular, in patients with ≤10 years of diabetes. A trend of CRT reduction in the combined therapy group has been observed also considering patients with subfoveal neuroretinal detachment. In addition, we observed that the reduction of inner retinal layer thickness was greater in the combination group, in comparison with controls. Conclusion: The combination of a CHC to DEX-IVT is a promising therapeutic option in case of DME, in particular, for patients with early-stage diabetes and with an inflammatory phenotype. Further studies will be necessary to confirm these findings.
Highlights
IntroductionDiabetic macular edema (DME) is the leading cause of vision loss in diabetic patients (Daruich et al, 2018)
Diabetic macular edema (DME) is the leading cause of vision loss in diabetic patients (Daruich et al, 2018).The treatment of DME still appears difficult
It is worthy of note that antiVEGF agents and steroids, used in clinical practice, are considerably different in terms of molecular interactions when they bind with VEGF (Platania et al, 2015); characterization of such features can improve the design of novel drugs in reducing the intravitreal (IVT) injection
Summary
Diabetic macular edema (DME) is the leading cause of vision loss in diabetic patients (Daruich et al, 2018). The treatment of DME still appears difficult. Even if the destruction of the blood–retinal barrier (BRB) is the primary pathological feature, the inflammatory component plays a crucial role in the development of this condition. It is worthy of note that antiVEGF agents and steroids, used in clinical practice, are considerably different in terms of molecular interactions when they bind with VEGF (Platania et al, 2015); characterization of such features can improve the design of novel drugs in reducing the intravitreal (IVT) injection. IVT corticosteroids and, among them, slow-release dexamethasone IVT injection (DEX-IVT) have been shown to block the production of several inflammatory mediators, such as VEGF and intercellular adhesion molecule 1 (ICAM-1), and to inhibit leukostasis (Tamura et al, 2005; Platania et al, 2015)
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