A Clinical Trial of Acyclovir for Viral Uveitis

Xiaomin Zhang30 enrolled

Overview

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

Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the study design, aims, benefits and potential risks. This is a prospective non-comparative interventional study. Aqueous humor samples were collected from participants to virus detection. Participants will take oral acyclovir 100 mg three times a day and data will be collected prospectively with regard to ophthalmologic outcomes. Study participants will be followed for up to 12 months to determine efficacy, and an additional 30 days for safety reports. Descriptive statistics will be gathered on participant demographics, uveitis characteristics, change in immunosuppressive medications, number of responders, ophthalmologic measures and change in corticosteroid dose during the study period.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uveitis

Interventions

AcyclovirDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Mean and median change in best corrected visual acuity in logMAR

Time frame: 12 weeks

Secondary Outcomes

Number of participants who experience a recurrence

Time frame: 12 weeks

Length of time to quiescence

Time frame: 12 weeks

Ability to taper concomitant immunosuppressive medications

Time frame: 12 weeks

Number and severity of systemic and ocular toxicities and adverse events

Time frame: 12 weeks

Central Contacts

Xiaomin Zhang, M.D.

CONTACT

+86-13920023990

Jing Yang

CONTACT

+86-13002215386

Data from ClinicalTrials.gov

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