A Clinical Trial of Acyclovir for Viral Uveitis

NCT03389191 | Unknown

• 1 other identifier: 2017KY-07
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This project is designed to test the hypothesis that acyclovir is clinically useful for patients with refractory viral uveitis.

Conditions

Uveitis

Outcome Measures

Primary Outcomes (1)

• Mean and median change in best corrected visual acuity in logMAR

  Mean and median change in best corrected visual acuity in logMAR

  12 weeks

Secondary Outcomes (4)

• Number of participants who experience a recurrence

  12 weeks

• Length of time to quiescence

  12 weeks

• Ability to taper concomitant immunosuppressive medications

  12 weeks

• Number and severity of systemic and ocular toxicities and adverse events

  12 weeks

Study Arms (1)

Patients with Viral Uveitis

EXPERIMENTAL

Oral acyclovir 100 mg three times a day (TID).

Drug: Acyclovir

Interventions

Acyclovir DRUG

Patients with Viral Uveitis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and above.
• Chronic, vision threatening viral uveitis.
• Patients can't tolerate hormone therapy bacause of drug side effects.
• Consent to undergo anterior chamber tap and give aqueous for the study.
• Able to undergo relevant tests.
• Able to come for subsequent follow-up visits.
• Ability to provide informed consent.

You may not qualify if:

• Patients who are allergic to ayclovir.
• Immunocompromised patients
• Positive for HIV, Hep B and Hep C
• Not keen on participating in the study
• Patients who are incapable, either by law or mental state, of giving consents in their own right.
• Patients who are either unable or unwilling to keep scheduled appointments and adhere to the other aspects of the protocol.
• Patients who are pregnant or breastfeeding.
• Any other specified reason as determined by the clinical investigator.

Sponsors & Collaborators

• Xiaomin Zhang: lead

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Uveitis

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Xiaomin Zhang, M.D.

  Tianjin Medical University Eye Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaomin Zhang, M.D.

CONTACT

+86-13920023990

Jing Yang

CONTACT

+86-13002215386

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 3, 2018
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2021
• Last Updated: April 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will become available starting 6 months after publication.
• Access Criteria: Study protocol, statistical analysis plan and informed Consent form can be shared with other researchers. And researchers will review requests and criteria for reviewing requests.

Locations

CN (1)