Effect of Intravitreous Aflibercept vs Vitrectomy With Panretinal Photocoagulation on Visual Acuity in Patients With Vitreous Hemorrhage From Proliferative Diabetic Retinopathy

Abstract

IMPORTANCE Vitreous hemorrhage from proliferative diabetic retinopathy can cause loss of vision. The best management approach is unknown.OBJECTIVE To compare initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation for vitreous hemorrhage from proliferative diabetic retinopathy. DESIGN, SETTING, AND PARTICIPANTSRandomized clinical trial at 39 DRCR Retina Network sites in the US and Canada including 205 adults with vison loss due to vitreous hemorrhage from proliferative diabetic retinopathy who were enrolled from November 2016 to December 2017. The final follow-up visit was completed in January 2020.INTERVENTIONS Random assignment of eyes (1 per participant) to aflibercept (100 participants) or vitrectomy with panretinal photocoagulation (105 participants). Participants whose eyes were assigned to aflibercept initially received 4 monthly injections. Both groups could receive aflibercept or vitrectomy during follow-up based on protocol criteria. MAIN OUTCOMES AND MEASURESThe primary outcome was mean visual acuity letter score (range, 0-100; higher scores indicate better vision) over 24 weeks (area under the curve); the study was powered to detect a difference of 8 letters. Secondary outcomes included mean visual acuity at 4 weeks and 2 years. RESULTS Among 205 participants (205 eyes) who were randomized (mean [SD] age, 57 [11] years; 115 [56%] men; mean visual acuity letter score, 34.5 [Snellen equivalent, 20/200]), 95% (195 of 205) completed the 24-week visit and 90% (177 of 196, excluding 9 deaths) completed the 2-year visit. The mean visual acuity letter score over 24 weeks was 59.3(Snellen equivalent, 20/63) (95% CI, 54.9 to 63.7) in the aflibercept group vs 63.0 (Snellen equivalent, 20/63) (95% CI, 58.6 to 67.3) in the vitrectomy group (adjusted difference, −5.0 [95% CI, −10.2 to 0.3], P = .06). Among 23 secondary outcomes, 15 showed no significant difference. The mean visual acuity letter score was 52.6 (Snellen equivalent, 20/100) in the aflibercept group vs 62.3 (Snellen equivalent, 20/63) in the vitrectomy group at 4 weeks (adjusted difference, −11.2 [95% CI, −18.5 to −3.9], P = .003) and 73.7 (Snellen equivalent, 20/40) vs 71.0 (Snellen equivalent, 20/40) at 2 years (adjusted difference, 2.7 [95% CI, −3.1 to 8.4], P = .36). Over 2 years, 33 eyes (33%) assigned to aflibercept received vitrectomy and 34 eyes (32%) assigned to vitrectomy received subsequent aflibercept.CONCLUSIONS AND RELEVANCE Among participants whose eyes had vitreous hemorrhage from proliferative diabetic retinopathy, there was no statistically significant difference in the primary outcome of mean visual acuity letter score over 24 weeks following initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation. However, the study may have been underpowered, considering the range of the 95% CI, to detect a clinically important benefit in favor of initial vitrectomy with panretinal photocoagulation.

Intravitreal Anti-Vascular Endothelial Growth Factor Agents for the Treatment of Diabetic Retinopathy: A Review of the Literature

“…However, recurrent VH occurred at least once in 49% of patients in the aflibercept and in 15% in the vitrectomy group. Therefore, the authors underlined that the study may have been underpowered to detect a clinically important benefit in favor of initial PPV with PRP [ 72 ]. It has to be mentioned that although visual outcomes were not significantly different between treatment groups from 12 weeks through 2 years, additional findings from this study may help clinicians guide therapeutic decisions for individuals with VH.…”

Aflibercept in Diabetic Retinopathy

“…They also highlight the potential for type I error within their statistical analysis and so "findings for secondary endpoints should be interpreted as exploratory". 36 TOUCHREVIEWS IN OPHTHALMOLOGY AB showed that there was no statistical difference in visual acuity outcomes between aflibercept versus vitrectomy with PRP. Protocol AB results suggest that aflibercept use was associated with less occurrence of DMO relative to vitrectomy with PRP.…”

Diabetische Retinopathie

“…In einer vergleichenden Studie bei Patienten mit Glaskörperblutung wurde die Standardtherapie (ppV mit Endolaser) mit intravitrealen Aflibercept-Gaben verglichen. Dabei zeigte sich in beiden Gruppen nach 6 Monaten ver-gleichbar gute Visusäquivalente, jedoch mehr traktive Netzhautablösungen in der IVOM-Gruppe (22 vs. 13 %) [36]. Die Behandlung einer Glaskörperblutung mit VEGF-Hemmern ist daher ein Risiko und immer mit Unsicherheiten aufgrund des fehlenden Funduseinblicks verbunden.…”