Affiliation:
1. Sanmenxia Eye Hospital, Sanmenxia Central Hospital, Henan University of Science and Technology
Abstract
Abstract
Purpose
to compare the safety and efficacy of intravitreal injection of ranibizumab alone or ranibizumab combined with dexamethasone intravitreal implant in the treatment of macular edema secondary to retinal vein occlusion.
Study Design:
a single center, case-controlled, prospective cohort study (Clinical Trail Registration Number: ChiCTR2400080048).
Methods
patients with macular edema secondary to retinal vein occlusion who visited our hospital from August 2020 to August 2022 were enrolled. The patients were randomized into the ranibizumab group and the combination group (ranibizumab combined with dexamethasone intravitreal implant). The patients in both groups received ranibizumab intravitreal injections in the first three months as the initial treatment. However, in the ranibizumab group, patients might receive repeat injections during the follow-up in case of the recurrence of macular edema; in the combination group, patients received an intravitreal injection of dexamethasone implant after the first injection of ranibizumab at the day 15. The main outcome evaluations are best-corrected visual acuity and reduction of central macular thickness. The secondary outcome evaluations are the numbers of recurrence, the average injection interval, and the number of injections. Adverse events, such as ocular hypertension, and subconjunctival hemorrhage were also recorded.
Results
44 eyes were assigned to the ranibizumab group (n = 23) and the combination group (n = 21). Compared with the ranibizumab group, the combination group showed a significantly greater improvement in best-corrected visual acuity at 1, 3, 6, and 12 months postoperatively. Both groups showed a decrease in central macular thickness at 1 week and 1, 3, 6, and 12 months, compared with the baseline (P < 0.05). However, the combination group did not exhibit higher central macular thickness-reducing effects than the ranibizumab group (P > 0.05). Compared with the ranibizumab group, the combination group required a significantly lower average number of injections (P = 0.011) and had a significantly lower number of macular edema recurrences (P < 0.001) and significantly prolonged average time to re-injection (P = 0.05). The incidence of adverse events was not significantly different between the two groups (P = 0.944).
Conclusions
ranibizumab combined with dexamethasone intravitreal injection could sustainably and rapidly improve the best-corrected visual acuity of retinal vein occlusion patients with a good safety profile.
Publisher
Research Square Platform LLC