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.

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“…Aflibercept is a recombinant fusion protein that consists of portions of VEGF receptor (R) 1 and VEGFR2 extracellular domains fused to the Fc portion of human immunoglobulin G1 (Ig1). Unlike other anti-VEGF agents, it binds not only to all isoforms of VEGF-A, but also to VEGF-B and placental growth factor [16].…”

Update on the Management of Diabetic Retinopathy: Anti-VEGF Agents for the Prevention of Complications and Progression of Nonproliferative and Proliferative Retinopathy

“…There was no statistically significant difference in visual acuity, but there was greater hemorrhage recurrence and longer time to clearance in eyes treated with intravitreal aflibercept + PRP compared with PPV by the final nine-month follow-up. On average, time to clearance was eight weeks in eyes treated with aflibercept and PRP, versus five days in eyes treated with PPV [ 69 ].…”

Concentration of Vascular Endothelial Growth Factor in the Vitreous and Features of Vitrectomy in Patients with Proliferative Diabetic Retinopathy after Various Doses of Intravitreal Aflibercept

“…Афлиберсепт является рекомбинантным человеческим гибридным белком, который состоит из фрагментов внеклеточных доменов человеческих рецепторов ФРЭС-1 (ФРЭС-R1) и -2 (ФРЭС-R2), соединенных Fc-фрагментом человеческого иммуноглобулина G (IgG1). Афлиберсепт, в отличие от других препаратов ингибиторов ФРЭС, связывает не только все изоформы ФРЭС-A, но и плацентарный фактор роста, и ФРЭС-В [14]. В наших предварительных исследованиях было установлено, что интравитреальное введение афлиберсепта в дозировке 1 и 2 мг приводит к фибротизации фиброваскулярных ЭРМ с выраженным пролиферативным компонентом и облитерации новообразованных сосудов на 3-и и 5-е сутки после инъекции, однако уровень ФРЭС в стекловидном теле и особенности витрэктомии при этом не изучались [18,19].…”