Safety of 6000 Intravitreal Dexamethasone Implants

Written by: Katherine E. Talcott, MD

Rajesh B, Zarranz-Ventura J, Fung AT et al. Safety of 6000 intravitreal dexamethasone implants. Br J Ophthalmol. 2019 April 30. [Epub ahead of print]

Corticosteroids, including the intravitreal dexamethasone implant, are used to treat macular edema from multiple etiologies. Clinical trials have revealed an increase in IOP and cataract progression but real-life studies have help elucidate a better understanding of the implant’s safety profile. Recently, Rajesh et al pooled data from multiple centers from around the world to evaluate the real-life safety profile of intravitreal dexamethasone implant injections.

This was a retrospective multicenter analysis involving 25 centers. Eyes were included if they had at least 6 months of follow-up after the last injection. Eyes previously treated with anti-VEGF agents or laser were included but concomitant treatment during the study period was an exclusion criterion. IOP greater than 25 mmHg was considered to be significant ocular hypertension. 6015 intravitreal dexamethasone implant injections in 2736 eyes of 1441 patients were included. Patients received injections due to various retinal conditions including central retinal vein occlusion (1861 injections), diabetic macular edema (3104 injections), post-operative cystoid macular edema (305 injections) and uveitis (381 injections). Mean duration of follow-up was 18.9 months.

The main endpoints the authors considered was cataract progression and IOP rise. 32.5% of phakic eyes developed cataracts and required surgery. Another 14.6% of phakic eyes had cataract progression but did not need surgery. 26.5% of eyes had significant ocular hypertension. More than 90% of these eyes were managed medically but 0.5% required surgery. More serious side effects of endophthalmitis, retinal detachment and vitreous hemorrhage were rare (all less than 0.07%). Of note, the authors did not find a significant change in visual acuity or central macular thickness at the last OCT.

The results of this large multicenter real-life study assessing the safety of intravitreal dexamethasone implant injections found that approximately one-third of phakic patients developed a cataract requiring surgery. Approximately one-quarter had IOP elevation but most were managed medically. This information can be helpful in counseling patients and deciding amongst treatment options.