Retina Today - Key Takeaways From the Latest Clinical Trials in Diabetic Eye Disease (March 2018)

摘要

Several recent trials have examined novel approaches to the treatment of diabetic macular edema (DME): • The TREX-DME trial compared outcomes of a monthly anti-VEGF treatment regimen to those achieved with two treat-and-extend (TAE) regimens. • The HULK trial investigated the role of suprachoroidal steroid administration. • Protocol U of the Diabetic Retinopathy Clinical Research Network (DRCR.net) analyzed the role of intravitreal steroids in patients with treatment-resistant DME. This article reviews some of the notable findings from these trials and their implications for retina practice. AT A GLANCE • In TREX-DME, a statistically significantly decreased treatment burden was seen with use of two treat-and-extend regimens as compared with monthly injections. • In the HULK phase 1/2 trial of suprachoroidal steroid administration, visual gains were more prominent in treatment-naïve patients than in previously treated patients. • In DRCR.net Protocol U, addition of intravitreous dexamethasone to continued ranibizumab therapy in patients with persistent DME did not improve visual acuity at 24 weeks compared with ranibizumab monotherapy. TREX-DME Previous pivotal studies in DME such as RISE and RIDE have shown that a monthly injection regimen works well to improve vision and decrease macular edema.1 However, in real-world practice, retina specialists do not always perform monthly injections. Thus, it is important to establish how other commonly used treatment algorithms, such as TAE, compare to monthly injections. Additionally, innovations in focal laser administration might also affect the visual and anatomic outcomes in this patient population. TREX-DME is a multicenter, prospective, randomized clinical trial comparing the efficacy of a TAE dosing algorithm, with and without angiography-guided focal laser treatment, with monthly dosing for center-involving DME. Patients were randomly assigned to one of three groups: 30 eyes were treated with monthly ranibizumab 0.3 mg (Genentech), 60 eyes were treated with ranibizumab according to a TAE protocol without macular laser photocoagulation (TREX), and 60 eyes were treated according to a TAE protocol with angiography-guided macular laser photocoagulation (GILA). Patients in all three groups received initial monthly injections for 4 months. For the next 2 years, the monthly group was continued on monthly injections. In the TREX group, the treatment interval at each visit was extended by 2 weeks, maintained, or decreased by 2 weeks based on the patient’s central retinal thickness. Eyes in the GILA cohort were treated similarly to those in the TREX group but also received angiography-guided macular laser photocoagulation with the 532 nm Navilas laser system (OD-OS) at week 4 and again every 3 months if microaneurysm leakage was present on fluorescein angiography. One-year results of TREX-DME have been published.2 At that interval, TAE dosing, with and without angiography-guided macular laser photocoagulation, significantly decreased the number of injections given while providing similar visual and anatomic outcomes compared with monthly dosing. Adding angiography-guided laser photocoagulation to this dosing algorithm did not significantly improve outcomes at 1 year.2 The 2-year TREX-DME results, presented at the 2017 American Academy of Ophthalmology (AAO) Retina Subspecialty Day by David M. Brown, MD, indicated that the results seen at 1 year persisted.3 Improvements in best corrected visual acuity (BCVA) ETDRS letter score were not statistically significantly different among the three groups: monthly, +8.3; TREX, +11.4; and GILA, +10.5. Anatomic results on spectral-domain optical coherence tomography were also similar among groups. There was a statistically significantly decreased treatment burden, including lower numbers of treatment visits and longer treatment intervals, in both TAE groups compared wi