Systemic and Topical Antiviral Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes - Trials I and II

Summary

The goal of this clinical trial is to compare antiviral treatment strategies for cytomegalovirus (CMV) anterior uveitis - a viral infection causing inflammation inside the front of the eye - in immunocompetent adults aged 18 years and older. The main questions it aims to answer are: Does oral valganciclovir reduce aqueous humor CMV viral load more effectively than topical ganciclovir 2% eye drops or placebo after 7 days of treatment (Trial I)? Does long-term suppressive antiviral therapy (oral valganciclovir or topical ganciclovir 2% eye drops) reduce the rate of CMV anterior uveitis recurrence over 12 months compared to placebo (Trial II)? Researchers will compare oral valganciclovir, topical ganciclovir 2% eye drops, and placebo to see if either antiviral treatment reduces viral load and controls eye inflammation more effectively in the short term, and whether long-term antiviral suppression can prevent the disease from coming back after the inflammation has been controlled. Participants will: * Undergo anterior chamber paracentesis (removal of a small amount of fluid from the front of the eye) for PCR testing to confirm CMV as the cause of their eye inflammation before enrollment * Be randomly assigned to receive oral valganciclovir 900 mg twice daily, topical ganciclovir 2% eye drops six times daily, or placebo for 7 days (Trial I), in addition to standard steroid eye drops * Return for follow-up visits at Day 7 and Day 21 for eye examinations, laboratory blood tests, and a second anterior chamber paracentesis at Day 7 to measure viral load after treatment * If eye inflammation is controlled after Trial I, be offered enrollment into Trial II, where they will be randomly assigned to long-term suppressive oral valganciclovir, topical ganciclovir 2% eye drops, or placebo for 12 months, with follow-up visits approximately every 2 months and additional visits if inflammation returns

Timeline

Start

2026-07-01

Primary completion

2031-12-31

Completion

2032-10-31

Publications

• Background Somkijrungroj T, Laovirojjanakul W, Xiong F, et al. Systemic and topical control of active cytomegalovirus anterior uveitis: a randomized-controlled trial. British Journal of Ophthalmology. 2026;in submission
• Background Zuhair M, Smit GSA, Wallis G, Jabbar F, Smith C, Devleesschauwer B, Griffiths P. Estimation of the worldwide seroprevalence of cytomegalovirus: A systematic review and meta-analysis. Rev Med Virol. 2019 May;29(3):e2034. doi: 10.1002/rmv.2034. Epub 2019 Jan 31.
• Background Chan NS, Chee SP, Caspers L, Bodaghi B. Clinical Features of CMV-Associated Anterior Uveitis. Ocul Immunol Inflamm. 2018;26(1):107-115. doi: 10.1080/09273948.2017.1394471. Epub 2017 Nov 27.
• Background Chen X, Li C, Peng X, Lum F, McLeod SD, Acharya NR. Use of Anterior Chamber Paracentesis for Diagnosis in Viral Anterior Uveitis. Ophthalmology. 2024 May;131(5):634-636. doi: 10.1016/j.ophtha.2023.12.034. Epub 2024 Jan 4. No abstract available.
• Background Benador-Shen C, Shantha J, Lee J, Qian Y, Doan T, Gonzales JA. Multiple Anterior Chamber Paracenteses May Be Needed to Identify Cytomegalovirus Anterior Uveitis. Am J Ophthalmol. 2025 Jan;269:189-194. doi: 10.1016/j.ajo.2024.08.025. Epub 2024 Aug 31.
• Background Bhoopat T, Takhar JS, Oldenburg CE, Keenan JD, Gonzales JA, Margolis TP. Treatment of Cytomegalovirus Anterior Uveitis at a North American Tertiary Center With Oral Valganciclovir. Cornea. 2020 May;39(5):584-589. doi: 10.1097/ICO.0000000000002251.
• Background Touhami S, Qu L, Angi M, Bojanova M, Touitou V, Lehoang P, Rozenberg F, Bodaghi B. Cytomegalovirus Anterior Uveitis: Clinical Characteristics and Long-term Outcomes in a French Series. Am J Ophthalmol. 2018 Oct;194:134-142. doi: 10.1016/j.ajo.2018.07.021. Epub 2018 Jul 26.
• Background Tranos P, Markomichelakis N, Koronis S, Sidiropoulos G, Tranou M, Rasoglou A, Stavrakas P. CMV-Related Anterior Uveitis in a Mediterranean European Population: Clinical Features, Prognosis, and Long-Term Treatment Outcomes. Ocul Immunol Inflamm. 2024 Nov;32(9):2138-2143. doi: 10.1080/09273948.2024.2329315. Epub 2024 Apr 15.
• Background Chronopoulos A, Roquelaure D, Souteyrand G, Seebach JD, Schutz JS, Thumann G. Aqueous humor polymerase chain reaction in uveitis - utility and safety. BMC Ophthalmol. 2016 Oct 28;16(1):189. doi: 10.1186/s12886-016-0369-z.
• Background Trivedi D, Denniston AK, Murray PI. Safety profile of anterior chamber paracentesis performed at the slit lamp. Clin Exp Ophthalmol. 2011 Nov;39(8):725-8. doi: 10.1111/j.1442-9071.2011.02565.x. Epub 2011 Apr 27.
• Background Sheng Q, Zhai R, Fan X, Kong X. 2% Ganciclovir Eye Drops Control Posner-Schlossman Syndrome Relapses With/Without Cytomegalovirus Intraocular Reactivation. Front Med (Lausanne). 2022 Mar 9;9:848820. doi: 10.3389/fmed.2022.848820. eCollection 2022.
• Background Chen PJ, Lin IH, Chi YC, Lai CC, Hung JH, Tseng SH, Huang YH. Long-Term Outcome of Treatment with 2% Topical Ganciclovir Solution in Cytomegalovirus Anterior Uveitis and Corneal Endotheliitis. Infect Drug Resist. 2022 Jun 29;15:3395-3403. doi: 10.2147/IDR.S370905. eCollection 2022.
• Background Keorochana N, Choontanom R. Efficacy and safety of an extemporaneous preparation of 2% ganciclovir eye drops in CMV anterior uveitis. BMJ Open Ophthalmol. 2017 Sep 7;2(1):e000061. doi: 10.1136/bmjophth-2016-000061. eCollection 2017.
• Background Chee SP, Jap A. Cytomegalovirus anterior uveitis: outcome of treatment. Br J Ophthalmol. 2010 Dec;94(12):1648-52. doi: 10.1136/bjo.2009.167767. Epub 2010 Jun 24.
• Background Hsiao YT, Kuo MT, Chiang WY, Chao TL, Kuo HK. Epidemiology and clinical features of viral anterior uveitis in southern Taiwan-diagnosis with polymerase chain reaction. BMC Ophthalmol. 2019 Apr 3;19(1):87. doi: 10.1186/s12886-019-1093-2.
• Background Park SW, Yu HG. Association of cytomegalovirus with idiopathic chronic anterior uveitis with ocular hypertension in Korean patients. Ocul Immunol Inflamm. 2013 Jun;21(3):192-6. doi: 10.3109/09273948.2012.754908. Epub 2013 Mar 12.
• Background Dunn JP, MacCumber MW, Forman MS, Charache P, Apuzzo L, Jabs DA. Viral sensitivity testing in patients with cytomegalovirus retinitis clinically resistant to foscarnet or ganciclovir. Am J Ophthalmol. 1995 May;119(5):587-96. doi: 10.1016/s0002-9394(14)70217-x.

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