Abstract
Purpose :
To evaluate the safety and effectiveness of intravitreal Sirolimus in chronic and persistent exudative age-related macular degeneration (AMD).
Methods :
In this prospective, subject-masked study, patients were randomized to monthly anti-vascular endothelial growth factor (anti-VEGF) treatment or to intravitreal Sirolimus (440 µg) at months 0, 2 and 4. Safety and effectiveness outcomes were measured monthly up to month six, with an extension to one year for patients who remained in the study. The primary outcome was the change in central subfield thickness and the secondary outcomes were the change in total subretinal fluid, total intraretinal fluid, choroidal neovascularization volume and visual acuity.
Results :
The CST increased by 7.5 µm in the anti-VEGF group and decreased by 30.0 µm in the Sirolimus group at month six (p<0.05). On subgroup analysis for patients receiving Sirolimus, a trend towards greater reduction in the CST was found in patients with fewer prior injections, longer duration of disease and greater initial CST. The presence of IRF at baseline did not affect CST outcomes. In addition to the central subfield thickness, a statistically significant decrease in total subretinal fluid occurred in the Sirolimus group.
At six months, the number of patients who gained 5 or more Early Treatment of Diabetic Retinopathy Study (ETDRS) letters was 9 in each group (p=0.91). The number of patients who gained or lost less than 5 ETDRS letters was 11 in the anti-VEGF group and 7 in the Sirolimus group (p=0.40). The difference in the number of serious systemic or ocular adverse events between the two groups was not statistically different.
Conclusions :
This study demonstrates Sirolimus as a promising new therapy for chronic and persistent exudative AMD. Sirolimus decreased the central subfield thickness and subretinal fluid more effectively than anti-VEGF agents and had a similar safety profile.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.