Efficacy and safety profile of intravitreal dexamethasone implant versus antivascular endothelial growth factor treatment in diabetic macular edema: a systematic review and meta-analysis

Abstract

To better understand the efficacy of intravitreal dexamethasone implant (Ozurdex) versus antivascular endothelial growth factor (anti-VEGF) treatment in patients with diabetic macular edema (DME). A systematic review and meta-analysis. The study included randomized control trials (RCTs) and non-randomized control trials (Non-RCTs) before December 2021 that compare the efficacy of Ozurdex-related therapyand anti-VEGF therapy. We searched PubMed, Cochrane Library, and EMBASE. The quality of the included studies was assessed carefully. 30 studies were included. Regarding BCVA change, the overall result revealed no significant differences between Ozurdex and anti-VEGF therapies in patients with nonresistant DME, but Ozurdex group had significantly more VA improvement than anti-VEGF therapies in patients with resistant DME (MD 0.12, 95% CI 0.02–0.21). In terms of central retinal thickness (CRT) decrease, there was a significant difference between Ozurdex therapy and anti-VEGF therapy in patients with nonresistant DME (MD 48.10, 95% CI 19.06–77.13) and resistant DME (MD 65.37, 95% CI 3.62–127.13). Overall, Ozurdex therapy resulted in significantly greater VA improvement and CRT decrease than anti-VEGF therapy in resistant DME patients. Ozurdex therapy was not inferior to anti-VEGF therapy in patients with nonresistant DME.

Intravitreal OZURDEX vs. Intravitreal Bevacizumab for Diabetic Macular Edema: A Comprehensive Review

“…However, cataracts in phakic patients negatively impacted visual acuity during the study [ 24 ]. In a systematic review and meta-analysis comparing the efficacy of intravitreal DEX implant (OZURDEX) vs. anti-VEGF therapies, no significant differences in BCVA change were observed between OZURDEX and anti-VEGF therapies in patients with non-resistant DME [ 25 ]. However, when considering baseline central retinal thickness (CRT), the meta-regression analysis indicated that a baseline CRT exceeding 410 µm could be a critical factor influencing the anatomical outcome in favor of OZURDEX therapy [ 25 ].…”

“…In a systematic review and meta-analysis comparing the efficacy of intravitreal DEX implant (OZURDEX) vs. anti-VEGF therapies, no significant differences in BCVA change were observed between OZURDEX and anti-VEGF therapies in patients with non-resistant DME [ 25 ]. However, when considering baseline central retinal thickness (CRT), the meta-regression analysis indicated that a baseline CRT exceeding 410 µm could be a critical factor influencing the anatomical outcome in favor of OZURDEX therapy [ 25 ]. Regarding safety, pooled results from two multicenter, masked, randomized, sham-controlled studies revealed no significant difference in intraocular pressure (IOP) change between the OZURDEX and anti-VEGF groups [ 24 ].…”

“…OZURDEX is indicated as an alternative treatment option for DME patients who exhibit suboptimal responses to anti-VEGF therapy [ 52 ]. Proper preparation, including anesthesia and the use of a broad-spectrum microbicide, is stressed before administering intravitreal therapy to ensure safety during injections [ 25 ].…”

The Treatment of Diabetic Retinal Edema with Intravitreal Steroids: How and When

“…In general, the comparison of the Ozurdex IV implant and anti-VEGF in DME eyes has shown that Ozurdex is associated with the following: lower BCVA gain [ 107 , 108 , 120 ], which became comparable to anti-VEGF when pseudophakic eyes were analyzed separately [ 107 , 108 , 115 ]; better anatomical results, i.e., higher ability in reducing the macular edema, that did not translate directly into better BCVA improvements [ 107 , 115 , 120 , 121 , 122 , 123 , 124 ], which may be likely due to the cataract development; comparative better results in naïve than in non-naïve eyes, whereas the outcomes in the two groups appear similar in anti-VEGF studies [ 105 ]; better results in chronic and persistent DME eyes and in eyes with moderate-severe DME (CRT > 410 microns) [ 124 , 125 ] better outcomes in real-life studies than in interventional studies [ 126 ]: the possibility of retreating at an earlier stage and the higher number of naïve (2/3 of treatment-naïve eyes in anti-VEGF studies vs. 1/5 in the Ozurdex studies), or short duration DME eyes with better baseline VA in the real-life studies, may explain these differences (on the other hand, systematic review and meta-analysis studies have demonstrated that IV anti-VEGF showed better anatomical and functional results in RCTs compared to the observational studies, likely because fewer injections are administered in the observation studies than those suggested by the RCTs [ 105 , 120 , 126 ], and VA gain seems to be strictly related to the number of the IV injections, at least during the first year of therapy [ 127 , 128 ]); higher risk of OHT, glaucoma, and cataracts and lower risk of serious systemic adverse events [ 107 , 108 , 115 , 119 , 120 , 123 ]; lower number of required IV injections [ 105 , 107 , …”

“…better anatomical results, i.e., higher ability in reducing the macular edema, that did not translate directly into better BCVA improvements [ 107 , 115 , 120 , 121 , 122 , 123 , 124 ], which may be likely due to the cataract development;…”