A total of 26 eyes evenly divided between the two groups were included in the study. Both groups were well-matched at baseline.
Dr. Singh reported that within 90 days postoperatively, macular edema developed in a high number of patients in both groups, i.e., 69.2% of eyes in the sham group versus 61.5% of eyes in the aflibercept group. Of these, 15.4% and 38.5%, respectively, in the aflibercept and sham groups had an increase of 30% or more in the CST.
None and 15.4% had BCVA decreases of more than 5 letters from day 7; and 53.8% and 69.2% had cystoid abnormalities on OCT images. Of those that developed macular edema, 7.7% in both groups had all of the following: a 30% or greater increase in the CST, a decrease of more than 5 letters in the BCVA from day 7, and loss of visual acuity due to retinal thickening.
No significant differences were seen between the changes from baseline in BCVA and CST at day 90 between groups. No patient in either group had a loss of 15 or more letters.
About 38% of patients in the aflibercept group had 20/20 visual acuity on day 90, compared with 11.1% in the sham group. Significant differences in the CST were seen between the groups at days 30 (p = 0.02) and 60 (p = 0.01), Dr. Singh reported.
No adverse events
No serious adverse events occurred during the study. The most common non-serious events were tearing, itching, redness, foreign-body sensation, and corneal edema at 30 days in both study groups.
The most important findings that the investigators took from these data was that no adverse events developed as a result of the aflibercept injections and no patients in either groups experienced a loss of 15 letters or more of vision.
More patients achieved a 20/20 visual outcome from treatment with aflibercept and a smaller proportion of patients experienced worsening macular edema in the aflibercept-treated patients versus sham. Additional larger prospective studies are needed to further validate these findings.
“Retina specialists struggle when managing the diabetic patient with retinopathy in the setting of cataract surgery,” Dr. Singh concluded. “This phase II study shows some very interesting signals that intravitreal aflibercept is safe and effective at improving visual and anatomic outcomes after cataract surgery.”