Modified Microneedle for Suprachoroidal Injection of Triamcinolone Acetonide Combined with Intravitreal Injection of Ranibizumab in Branch Retinal Vein Occlusion Patients

Amin E Nawar, Amin E Nawar

Abstract

Purpose: The present study evaluated the efficacy of combined suprachoroidal injection of triamcinolone acetonide (TA) using a modified microneedle with intravitreal injection of ranibizumab in branch retinal vein occlusion (BRVO) patients.

Patients and methods: This is a prospective randomised interventional study that was conducted on 60 eyes of 60 patients with non ischemic BRVO. Patients were divided in two groups, group (1) 30 patients who received intravitreal injection of 0.05 mL (0.5 mg) of ranibizumab, group (2) included 30 patients who received baseline combined intravitreal injection of 0.05 mL (0.5 mg) of ranibizumab and suprachoroidal injection of triamcinolone acetonide (4mg/0.1mL), both groups received monthly injection of ranibizumab on pro-re-nata (PRN) regimen for 1 year duration of the study.

Results: Group 2 received less number of injections (2.47 ± 1.2) as compared to group 1 (4.4 ± 1.5). Both groups achieved significant reduction of central macular thickness (CMT) after 12 months of injection with p value <0.001. Both groups showed significant improvement of best corrected visual acuity (BCVA) after 12 months with p value <0.001. Group 2 showed more significant improvement of BCVA after 6 and 12 months. The baseline CMT and the number of injections were the main predictors of the final BCVA in group 1, while the baseline BCVA was the only predictor of final BCVA in group 2.

Conclusion: Combined suprachoroidal injection of TA using this modified microneedle with intravitreal injection of ranibizumab resulted in more significant improvement of BCVA and reduction of CMT compared with ranibizumab monotherapy with no reported ocular or systemic side effects. The study was prospectively registered with clinical trial.gov ID (NCT04690608) in 27-12-2020.

Keywords: branch retinal vein occlusion; suprachoroidal injection; triamcinolone acetonide.

Conflict of interest statement

The author has no relevant financial or non-financial conflicts of interest for this work to disclose.

© 2022 Nawar.

Figures

Figure 1
Figure 1
Central macular thickness at baseline, 1, 3, 6 and 12 months in the two groups.
Figure 2
Figure 2
Kaplan–Meier curve of macular edema recurrence in the two groups.
Figure 3
Figure 3
BCVA by log MAR at baseline, 1, 3, 6 and 12 months in the two group.
Figure 4
Figure 4
Female patient aged 55 years old presented with right upper temporal BRVO, the CMT was 295 um, the BCVA was 1.2 by log MAR (A), the patient received single combined intravitreal injection of ranibizumab (0.5mg) and suprachoroidal injection of TA (4 mg), the CMT declined to 195 um and BCVA improved to 0.3 after 1 month (B), after 3 months of the first injection, the CMT was 187 um and BCVA was 0.2 (C), after 6 months of the first injection, the CMT was 192 um and BCVA was 0.2 (D), after 12 months of the first injection, the CMT was 185 um and BCVA was 0.2 (E).
Figure 5
Figure 5
Male patient aged 48 years old presented with right upper temporal BRVO, the CMT was 393 um, the BCVA was 1.3 by log MAR (A), the patient received 3 consecutive intravitreal injections of ranibizumab (0.5 mg), the CMT declined to 211 um and BCVA improved to 0.4 after 3 months (B), after 6 months of the first injection, recurrent ME occurred with CMT 332 um and the BCVA declined to 1.2 by log MAR (C), the patient received two additional injections of ranibizumab, after 12 months of the first injection, the CMT was 194 um and BCVA improved to 0.3 (D).

References

    1. Rogers S, McIntosh RL, Cheung N, Lim L, Wang JJ, Mitchell P. The prevalence of retinal vein occlusion: pooled data from population studies from the United States, Europe, Asia, and Australia. Ophthalmology. 2010;117(2):313–319. doi:10.1016/j.ophtha.2009.07.017
    1. Noma H, Yasuda K, Shimura M. Cytokines and the pathogenesis of macular edema in branch retinal vein occlusion. J Ophthalmol. 2019;2019:1–9. doi:10.1155/2019/5185128
    1. Weinberg D, Dodwell DG, Fern SA. Anatomy of arteriovenous crossings in branch retinal vein occlusion. Am J Ophthalmol. 1990;109(3):298–302. doi:10.1016/s0002-9394(14)74554-4
    1. Feist RM, Ticho BH, Shapiro MJ, Farber M. Branch retinal vein occlusion and quadratic variation in arteriovenous crossings. Am J Ophthalmol. 1992;113(6):664–668. doi:10.1016/s0002-9394(14)74791-9
    1. Hayreh SS, Zimmerman MB. Branch retinal vein occlusion: natural history of visual outcome. JAMA Ophthalmol. 2014;132(1):13–22. doi:10.1001/jamaophthalmol.2013.5515
    1. Jonas J, Paques M, Mones J, Glacet-Bernard A. Retinal vein occlusions. Dev Ophthalmol. 2010;47:111–135. doi:10.1159/000320076
    1. Hayreh SS. Ocular vascular occlusive disorders: natural history of visual outcome. Prog Retin Eye Res. 2014;41:1–25. doi:10.1016/j.preteyeres.2014.04.001
    1. Kadomoto S, Muraoka Y, Uji A, Tamiya R, Oritani Y, Kawai K. Nonperfusion area quantification in branch retinal vein occlusion: a Widefield optical coherence tomography angiography study. Retina. 2021;41(6):1210–1218‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬. doi:10.1097/IAE.0000000000002999
    1. Gawęcki M. Subthreshold diode micropulse laser combined with intravitreal therapy for macular edema—A systematized review and critical approach. J Clin Med. 2021;10(7):1394. doi:10.3390/jcm10071394
    1. Barquet LA. Papel del factor de crecimiento del endotelio vascular en las enfermedades de la retina [Role of VEGF in diseases of the retina]. Arch Soc Esp Oftalmol. 2015;90:3–5. doi:10.1016/S0365-6691(15)30002-2
    1. Nozik RA. Periocular injection of steroids. Transactions-American Academy of Ophthalmology and Otolaryngology. Am Acad Ophthalmol Otolaryngol. 1972;76(3):695–705. PMID: 4677452.
    1. Munk MR, Bolz M, Huf W, et al. Morphologic and functional evaluations during development, resolution, and relapse of uveitis-associated cystoid macular edema. Retina. 2013;33(8):1673–1683. doi:10.1097/IAE.0b013e318285cc52
    1. Urbancic M, Gardasevic Topcic I. Dexamethasone implant in the management of diabetic macular edema from clinician’s perspective. Clin Ophthalmol. 2019;13:829–840. doi:10.2147/OPTH.S206769
    1. Edelhauser HF, Verhoeven RS, Burke B, Struble CB, Patel SR. Intraocular distribution and targeting of triamcinolone acetonide suspension administered into the suprachoroidal space. Invest Ophthalmol Vis Sci. 2014;55(13):5259.
    1. Campochiaro PA, Wykoff CC, Brown DM, et al. Suprachoroidal triamcinolone acetonide for retinal vein occlusion: results of the tanzanite study. Ophthalmol Retina. 2018;2(4):320–328. doi:10.1016/j.oret.2017.07.013
    1. Gilger BC, Abarca EM, Salmon JH, Patel S. Treatment of acute posterior uveitis in a porcine model by injection of triamcinolone acetonide into the suprachoroidal space using microneedles. Invest Ophthalmol Vis Sci. 2013;54(4):2483–2492. doi:10.1167/iovs.13-11747
    1. Yeh S, Kurup SK, Wang RC, et al. Suprachoroidal injection of triamcinolone acetonide, CLS-TA, for macular edema due to noninfectious uveitis: a randomized, Phase 2 study (DOGWOOD). Retina. 2019;39(10):1880–1888. doi:10.1097/IAE.0000000000002279
    1. Coscas G, Cunha-Vaz J, Soubrane G. Macular edema: definition and basic concepts. Dev Ophthalmol. 2010;47:1–9. doi:10.1159/000320070
    1. Augustin A, Loewenstein A, Kuppermann BD. General pathophysiology. Dev Ophthalmol. 2010;47:10–26. doi:10.1159/000320071
    1. Cimolai N. Comment on “Insights into the pathogenesis of cystoid macular edema: leukostasis and related cytokines”. Int J Ophthalmol. 2020;13(8):1343–1344. doi:10.18240/ijo.2020.08.25
    1. Campochiaro PA, Hafiz G, Mir TA, et al. Pro-permeability factors after dexamethasone implant in retinal vein occlusion; the Ozurdex for retinal vein occlusion (ORVO) study. Am J Ophthalmol. 2015;160(2):313–321. doi:10.1016/j.ajo.2015.04.025
    1. Patel SR, Berezovsky DE, McCarey BE, Zarnitsyn V, Edelhauser HF, Prausnitz MR. Targeted administration into the suprachoroidal space using a microneedle for drug delivery to the posterior segment of the eye. Invest Ophthalmol Vis Sci. 2012;53(8):4433–4441. doi:10.1167/iovs.12-9872
    1. Park SH, Lee KJ, Lee J, et al. Microneedle-based minimally- invasive measurement of puncture resistance and fracture toughness of sclera. Acta Biomater. 2016;44:286–294. doi:10.1016/j.actbio.2016.08.011
    1. Marashi A, Zazo A. A manually made needle for treating Pseudophakic cystoid macular edema by injecting triamcinolone acetonide in the suprachoroidal space: a case report. Am J Ophthalmol Case Rep. 2022;25:101254. doi:10.1016/j.ajoc.2021.101254
    1. Campochiaro PA, Sophie R, Pearlman J, Brown DM, Boyer DS, Heier JS. Long-term outcomes in patients with retinal vein occlusion treated with ranibizumab: the RETAIN Study. Ophthalmology. 2014;121(1):209–219. doi:10.1016/j.ophtha.2013.08.038
    1. Ali RI, Kapoor KG, Khan AN, Gibran SK. Efficacy of combined intravitreal bevacizumab and triamcinolone for branch retinal vein occlusion. Indian J Ophthalmol. 2014;62(4):396. doi:10.4103/0301-4738.120227
    1. Tadayoni R, Waldstein SM, Boscia F, Gerding H, Pearce I, Priglinger S. Individualized stabilization criteria-driven ranibizumab versus laser in branch retinal vein occlusion: six-month results of BRIGHTER. Ophthalmology. 2016;123(6):1332–1344. doi:10.1016/j.ophtha.2016.02.030
    1. Campochiaro PA, Heier JS, Feiner L, Gray S, Saroj N, Rundle AC. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a Phase III study. Ophthalmology. 2010;117(6):1102–1112. doi:10.1016/j.ophtha.2010.02.021
    1. Brown DM, Campochiaro PA, Bhisitkul RB, et al. Sustained benefits from ranibizumab for macular edema following branch retinal vein occlusion: 12-month outcomes of a phase III study. Ophthalmology. 2011;118(8):1594–1602. doi:10.1016/j.ophtha.2011.02.022
    1. Battaglia Parodi M, Romano F, Arrigo A, Mercuri S, Franceschi A, Bandello F. Ranibizumab for macular edema secondary to central and branch retinal vein occlusion in patients younger than 50 years of age. Biomed Res Int. 2020;2020:1–7.
    1. Zhang S, An N, Ha W, et al. Factors correlated with the resolution of macular oedema after one dose injection of intravitreal triamcinolone acetonide treatment in branch retinal vein occlusion. J Int Med Res. 2016;44(3):685–697. doi:10.1177/0300060515617386

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다