France: Secondary ocular hypertension (OHT) is one of the most concerning adverse events of sustained-release dexamethasone intravitreal implant.
SAFODEX-2 study by Dr, Amina Rezkallah MD, and team evaluated the incidence, risk factors, and time to onset of ocular hypertension after intravitreal injections (IVI) of dexamethasone implant and revealed that repeated injections of dexamethasone implant neither increased nor decreased the risk of OHT.
The findings of the study are published in Retina, the Journal of Retinal and Vitreous Diseases.
The objective of the study was to analyze the incidence, risk factors, and time to onset of ocular hypertension after intravitreal injections of dexamethasone implant and to evaluate the long-term cumulative probability of intraocular pressure elevation.
The study was designed as per the eyes of patients having received at least one dexamethasone implant IVI between October 2010 and February 2015 that were included in the present study. Ocular hypertension was defined as intraocular pressure > 25 mmHg and/or an increase of 10 mmHg over the follow-up period compared with baseline intraocular pressure.
A total of 494 eyes were studied in 410 patients. For a total of 1,371 IVI, the incidence of OHT was 32.6% in the study eyes with a mean follow-up period of 30 months and a median follow-up of 29 months.
The results of the study were:
• Pressure-lowering treatment was introduced for 36.9% of eyes. Topical treatment alone was sufficient to manage OHT in 97%.
• Young age, male sex, uveitis and retinal vein occlusion, and glaucoma treated with a double- or triple-combination topical pressure-lowering medication were found to be risk factors for OHT.
• The incidence of OHT did not change with an increase in the number of IVI, and there was no cumulative effect, defined by an increase of the incidence of OHT in patients after repeated IVI.
Dr Rezkallah and the team conveyed that this study confirmed that OHT is of moderate incidence, transient, and can be controlled by topical treatment. Their study provides data on the long-term cumulative probability of intraocular pressure elevation in a large cohort of eyes treated with dexamethasone implant IVI. They revealed that repeated injections of dexamethasone implant neither increased nor decreased the risk of OHT.
Reference:
Rezkallah, Amina MD*; Mathis, Thibaud MD*,†; Abukhashabah, Amro MD*; Voirin, Nicolas PhD*; Malclès, Ariane MD*; Agard, Émilie MD‡,§; Lereuil, Théo MD*; Denis, Philippe MD, PhD*; Dot, Corinne MD, PhD‡,§; Kodjikian, Laurent MD, PhD*,† LONG-TERM INCIDENCE AND RISK FACTORS OF OCULAR HYPERTENSION FOLLOWING DEXAMETHASONE-IMPLANT INJECTIONS, Retina: July 2021 - Volume 41 - Issue 7 - p 1438-1445 doi: 10.1097/IAE.000000000000308