NCT07513623

Brief 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

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for phase_2

Timeline
73mo left

Started Nov 2026

Longer than P75 for phase_2

Geographic Reach
3 countries

6 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2032

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

5.2 years

First QC Date

March 24, 2026

Last Update Submit

August 7, 2026

Conditions

Cytomegalovirus (CMV)Anterior UveitisInfectious UveitisCMV Infection

Keywords

Infectious uveitisCMV anterior uveitis

Outcome Measures

Primary Outcomes (2)

  • Primary Outcome Measure - Trial I

    Trial I Aqueous Humor CMV Viral Load at Day 7

    7 days

  • Primary Outcome Measure - Trial II

    Trial II Recurrence of Anterior Uveitis Inflammation Over 12 Months

    12 months

Secondary Outcomes (8)

  • Secondary Outcome Measure - Trial I

    7 days

  • Secondary Outcome Measure Trial I at 21 days

    21 days

  • Trial I intraocular pressure at 7 days

    7 days

  • Intraocular pressure at 21 days

    21 days

  • Visual acuity at 7 days

    7 days

  • +3 more secondary outcomes

Other Outcomes (4)

  • Trial topical ganciclovir 2% vs placebo

    7 days

  • Prevalence of CMV antiviral resistance mutations in Trial II recurences

    12 months

  • Host transcriptional profiles

    12 months

  • +1 more other outcomes

Study Arms (3)

Oral valganciclovir

ACTIVE COMPARATOR

Oral valganciclovir 900 mg twice daily.

Drug: Valganciclovir

Topical ganciclovir 2% eye drop

ACTIVE COMPARATOR

Topical ganciclovir instilled into affected eye 6 times daily.

Drug: Ganciclovir (GCV)

Placebo

PLACEBO COMPARATOR

This arm does not receive antiviral therapy, but this arm will receive topical corticosteroid eye drop like the other two active arms for inflammation management.

Drug: Placebo

Interventions

ValganciclovirDRUG

Trial I will use oral valganciclovir 450 mg tablet (2 tablets twice daily). Trial II will use oral valganciclovir 450 mg tablet (1 tablet twice daily).

Also known as: Oral valganciclovir
Oral valganciclovir
Ganciclovir (GCV)DRUG

Ganciclovir 2% eye drop (compounded).

Also known as: Topical ganciclovir eye drops
Topical ganciclovir 2% eye drop
PlaceboDRUG

Placebo tablets and placebo drops.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age at or above the age of majority at the time of enrollment (≥18 years of age in the United States; ≥20 years of age in Thailand and Taiwan)
  • Presenting with active anterior uveitis, defined as ≥1+ anterior chamber cell per -Standardization of Uveitis Nomenclature (SUN) Working Group criteria, in one or both eyes at the time of screening
  • Clinical features suggestive of a viral etiology for anterior uveitis, as determined by the treating study ophthalmologist, including but not limited to one or more of the following:
  • Unilateral hypertensive uveitis (elevated intraocular pressure in the setting of anterior chamber inflammation)
  • Coin-shaped or stellate keratic precipitates
  • Iris atrophy
  • Corneal endothelial changes consistent with CMV endotheliitis
  • Detection of cytomegalovirus (CMV) DNA by directed polymerase chain reaction (PCR) testing of aqueous humor obtained via anterior chamber paracentesis at the screening visit (Exam 0), as determined by local site PCR testing
  • Willingness and ability to provide written informed consent prior to enrollment and prior to any research-specific procedures
  • Willingness and ability to comply with study visit schedule, medication regimen, and study procedures for the duration of Trial I (21 days)
  • For participants of reproductive potential:
  • Female participants must agree to use at least one effective method of contraception during the study treatment period and for at least 30 days following the last dose of study medication
  • Male participants with female partners of reproductive potential must agree to use barrier contraception during the study treatment period and for at least 90 days following the last dose of study medication
  • Age at or above the age of majority (≥18 years of age in the United States; ≥20 years of age in Thailand and Taiwan)
  • Prior confirmed diagnosis of CMV anterior uveitis, established by positive PCR testing for CMV DNA in aqueous humor obtained via anterior chamber paracentesis during an active episode of anterior uveitis (uveitis flare). This confirmation may have been established either:
  • +9 more criteria

You may not qualify if:

  • Inactive anterior uveitis (≤0.5+ anterior chamber cell per SUN criteria) at the time of screening or enrollment
  • Intermediate uveitis, posterior uveitis, or panuveitis as the primary diagnosis, with or without concurrent anterior segment involvement
  • Detection of herpes simplex virus (HSV) or varicella zoster virus (VZV) by directed PCR testing of aqueous humor obtained at the screening paracentesis, regardless of whether CMV is also detected
  • Receipt of any antiviral therapy (systemic or topical ophthalmic) within 14 days prior to the screening visit
  • Receipt of a periocular or intraocular corticosteroid injection within 8 weeks prior to the screening visit
  • Current use of systemic immunosuppressive therapy, including but not limited to systemic corticosteroids (at doses exceeding the equivalent of prednisone 10 mg/day), immunomodulatory agents (e.g., methotrexate, mycophenolate mofetil, azathioprine, cyclosporine), or biologic agents
  • Known immunocompromising condition, including but not limited to:
  • Human immunodeficiency virus (HIV) infection, regardless of CD4 count or viral load
  • Solid organ or hematopoietic stem cell transplant recipient
  • Active malignancy requiring chemotherapy or radiation therapy
  • Primary or acquired immunodeficiency disorder
  • Abnormal screening laboratory values, specifically:
  • Absolute neutrophil count (ANC) \< 500 cells/µL
  • Platelet count \< 25,000/µL
  • Hemoglobin \< 8 g/dL
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Stein Eye Institute, University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Proctor Foundation, University of California San Francisco

San Francisco, California, 94158, United States

Location

Chang Gung University

Taoyuan, Taiwan

Location

Chulalongkorn University

Bangkok, Thailand

Location

Chiang Mai University

Chiang Mai, Thailand

Location

Khon Kaen University

Khon Kaen, Thailand

Location

Related Publications (17)

  • 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.

    PMID: 30706584BACKGROUND

  • 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.

    PMID: 29172842BACKGROUND

  • 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.

    PMID: 38184172BACKGROUND

  • 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.

    PMID: 39218387BACKGROUND

  • 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.

    PMID: 32068609BACKGROUND

  • 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.

    PMID: 30055154BACKGROUND

  • 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.

    PMID: 38621024BACKGROUND

  • 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.

    PMID: 27793120BACKGROUND

  • 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.

    PMID: 22050560BACKGROUND

  • 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.

    PMID: 35355609BACKGROUND

  • 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.

    PMID: 35791348BACKGROUND

  • 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.

    PMID: 29354718BACKGROUND

  • 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.

    PMID: 20576767BACKGROUND

  • 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.

    PMID: 30943921BACKGROUND

  • 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.

    PMID: 23480606BACKGROUND

  • 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.

    PMID: 7733184BACKGROUND

MeSH Terms

Conditions

Uveitis, AnteriorCytomegalovirus Infections

Interventions

ValganciclovirGanciclovir

Condition Hierarchy (Ancestors)

PanuveitisUveitisUveal DiseasesEye DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • John A Gonzales, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John A Gonzales, MD

CONTACT

415-476-1442john.gonzales@ucsf.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2026

First Posted

April 7, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

October 31, 2032

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared beyond the study team and authorized oversight bodies. The study involves sensitive personal health information from participants across international sites in the United States, Thailand, and Taiwan. Sharing IPD raises privacy and confidentiality concerns given variability in data protection regulations across jurisdictions. De-identified aggregate data and results will be made available through peer-reviewed publication and ClinicalTrials.gov results reporting. Requests for de-identified data for secondary research may be considered following primary results publication, subject to IRB approval and a data sharing agreement with the principal investigator.

Locations

TH(3)TW(1)US(2)