Intravitreal Aflibercept injection with Panretinal photocoagulation versus early Vitrectomy for diabetic vitreous hemorrhage: randomized clinical trial

Abstract

Background: To compare efficacy and safety of intravitreal aflibercept (IVA) injection with panretinal photocoagulation (PRP) versus early vitrectomy for diabetic vitreous hemorrhage (VH).

Methods: Prospective, randomized study that included 34 eyes with diabetic VH. They were divided into two groups, Group Ι (17 eyes) received three successive IVA injections followed by PRP and group ΙΙ (17 eyes) for whom early vitrectomy was done. Follow up was carried out after one, two, three, six and nine months. The primary outcome measure was change in the mean best corrected visual acuity (BCVA) after nine months, secondary outcome measures were mean duration of clearance of VH and rate of recurrent hemorrhage with any additional treatment in both groups. Complications were reported.

Results: There was no statistically significant difference regarding initial demographic criteria between both groups. The mean final log MAR BCVA was statistically better than the initial BCVA in both groups (0.51 ± 0.20, 1.17 ± 0.48 for group I and 0.48 ± 0.18, 1.44 ± 0.44 for group II, P < 0.001). There was no statistically significant difference between both groups regarding the mean final Log Mar BCVA (0.51 ± 0.20 for group I, 0.48 ± 0.18 for group II, p ≥ 0.05), the mean duration of clearance of VH was 7.8 ± 1.8 weeks, 5 days for group I and II respectively. PRP was completely done for all eyes in group I after three months. The difference in the recurrence rate between group I (29.4%) and group II (11.8%) was statistically significant (p < 0.05). Vitrectomy was done for three eyes (17.6%) due to recurrent non-resolving VH in group I. late recurrent VH occurred in two eyes (11.8%) in group II, IVA was given with complete clearance of the hemorrhage. No vision threatening complications were reported in both groups.

Conclusion: Both intravitreal injection of aflibercept followed by PRP and early vitrectomy are effective and safe modalities for treatment of diabetic vitreous hemorrhage. Early vitrectomy leads to faster vision gain with less incidence of recurrence than intravitreal injection.

Trial registration: Randomized clinical trial under the number of NCT04153253 on November 6, 2019 "Retrospectively registered".

Keywords: Intravitreal injection; Panretinal photocoagulation; Pars plana vitrectomy; Vitreous hemorrhage.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1

Flow chart for group I

Fig. 2

Flow chart for group II

Fig. 3

BCVA levels in both groups along study follow up visits. BCVA is measured in log MAR. Repeated measure ANOVA test results: Group I: Initial BCVA versus BCVA at one month was non-significant t (NS), initial versus two, three, six and nine months was significant (S). Group II: Initial versus one, two, three. Six and nine month was significant (S)

Fig. 4

Number of eyes with different final postoperative visual acuity levels in both groups. BCVA levels measured in Log MAR. Treated eyes were categorized according to final log MAR BCVA into three groups (better than 0.5, 0.5–0.7 and worse than 0.7)