Proportion of eyes with IOP-related events supported monitoring in eyes treated with anti-VEGF therapy for macular edema associated with CRVO or HRVO for up to 60 months.
A recent study investigated intraocular pressure (IOP) related events in participants who had macular edema associated with central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO), in order to determine overall risk assessment of initiating or continuing anti–vascular endothelial growth factor (anti-VEGF) injection therapy.
Led by Paul C. VanVeldhuisen, PhD, The Emmes Company, investigators found the proportion of eyes with IOP-related events in SCORE2 participants supported monitoring IOP in eyes treated with intravitreal anti-VEGF therapy for macular edema associated with CRVO or HRVO for up to 60 months.
The Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) was a multicenter, randomized, phase 3 clinical trial, where patients were randomized to receive 6 monthly intravitreal injections of either bevacizumab (1.25 mg) or aflibercept (2.0 mg).
The first randomization occurred in September 2014, with a data freeze in April 2020. Analysis then took place from April 2020 - December 2020.
During month 6, participants with a protocol-defined good response were randomly assigned to receive a monthly versus treat-and-extend (TAE) dosing regimen of their originally assigned study drug.
Those with a protocol-defined poor response during the same time period received either 3 monthly aflibercept injections followed by TAE aflibercept dosing for patients originally assigned to bevacizumab or intravitreal dexamethasone implant every 3 months for patients originally assigned to receive aflibercept. Then, at month 12, participants were treated per investigator discretion using any commercially available drug.
A total of 3 outcomes were measured, including the proportion of eyes with IOP elevation more than 10 mm Hg over baseline, proportion of eyes with IOP higher than 35 mm Hg and IOP-lowering incisional or laser surgery.
Enrollment in SCORE2 was a total of 362 participants, but following exclusion of 50 patients who were treated with IOP-lowering medication at baseline, 312 participants met inclusion criteria.
Of the total, 160 were randomized to aflibercept and 152 were randomized to bevacizumab, while 138 patients (44.2%) were female and had a mean age of 67.8 years. Data show the proportion of eyes with IOP elevation above 10 mm Hg over baseline was 8.0% (25 of 312), while the proportion of eyes with IOP higher than 35 mm Hg was 1.6% (5 of 312) over a 60-month follow-up.
VanVeldhuisen and colleagues noted the overall 60-month Kaplan-Meier cumulative incidence of IOP elevation more than 10 mm Hg over baseline was 0.13 (95% CI, 0.08 - 0.19) and the 60-month Kaplan-Meier cumulative incidence of IOP higher than 35 mm Hg was 0.02 (95% CI, 0.01 - 0.06).
No difference in the cumulative incidence of these 2 events through month 60 based on treatment assignment was observed (P = .22 for IOP elevation >10 mm Hg over baseline, and P = .60 for IOP >35 mm Hg).
Further, 3 participants (1.0%) underwent IOP-lowering incisional surgery for open-angle glaucoma, including 2 surgical procedures for participants initially assigned to receive aflibercept. Moreover, 3 patients (1.0%) underwent IOP-lowering glaucoma laser surgery.
“These findings suggest that the risk for an IOP-related event in eyes treated with intravitreal anti- VEGF injection therapy for macular edema warrants monitoring in the setting of CRVO or HRVO,'' investigators wrote.
The study, “Intraocular Pressure–Related Events After Anti–Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal Vein Occlusion or Hemiretinal Vein Occlusion,” was published in JAMA Ophthalmology.