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Peter Cikatricis, Ambreen Sarmad, Bushra Mushtaq, Samer Elsherbiny, Randhir Chavan, Erika Damato, Arijit Mitra, Yit C. Yang, Peck-Lin Lip; Staged Combination Therapy using Ranibizumab and Ozurdex for Retinal Vein Occlusion Macular Edema: The RandO Protocol.. Invest. Ophthalmol. Vis. Sci. 2016;57(12):4154.
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Published trials on RVO CME using intravitreal single-agents are effective but require up to 9 injections in the 1st year to stabilise CME. We hypothesized that a combination of anti-VEGF and steroid plus laser could yield compatible anatomical and visual outcomes and need less injections/year. In the RandO study, we investigated a treatment pathway for all new RVOs with or without CME, aiming primarily to eliminate ischemia with anti-VEGF and laser; and CME with anti-VEGF or Ozurdex.
Prospective 1 year data.RandO pathway: RVO patients with CME - 3 Ranibizumabs/3 months. Ischemia and CME assessed at each visit. Ozurdex used if CME showed inadequate response or recurrence. Ranibizumab and laser were given if ischemia persisted. Vision (Va), central retinal thickness (CRT) recorded at baseline and 1 year (compared using a paired Wilcoxon test). RVOs without CME - initially observed; only received Bevacizumab (3 injections/3 months) if retinopathy worsened, laser applied to ischemic eyes, patients would switch to RandO if CME developed. Number of injections/year and adverse effects were documented.
90 treatment-naïve CRVO:HRVO:BRVO=42:9:39.63(70%)-CME;27 without CME-15(55.5%) worsened and received either Bevacizumab or RandO. Of 14 Bevacizumab, only 2(14.2%) progressed to develop CME.66 patients received RandO:(i)Baseline Va 0.71[IQR 0.43-1.16], significantly improved to 0.48[IQR 0.18-0.78] (p<0.001] at 1 year(ii)Va improvement-77%, improved by 3-lines-52%, worse-15%(iii)Baseline median CRT-531μm[IQR 435-622], significantly reduced to 225μm[IQR 221-351] (p<0.001) at 1 year (97% improved CRT, 76% dry fovea).Mean number of injections/year-5.5; 4.5% needed≥9; 60% received Ozurdex, 81% received laser.Adverse effects: 22% ocular hypertension, no endophthalmitis, 18.2%(12/66) cataract surgery: 6/12(50%) worsened CME/retinopathy at 1st post-operative review. At presentation: 3 rubeotic glaucoma, 8 neovascular vitreous haemorrhage.
Staged combination therapies are effective in treating RVO CME with less injections needed in 1 year. Disease severity is related to higher rate of injections. Assessing and treating ischemia may enhance early stabilisation of disease. Caution in timing of cataract surgery. Treating RVO retinopathy early before CMO develops may halt the disease progression and prevent complications that require endless interventions.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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