A Clinical Trial of Acyclovir for Viral Uveitis

Uveitis Clinical Trial

Official title:

A Clinical Trial of Oral Acyclovir in Viral Uveitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03389191
• Other study ID #: 2017KY-07
• Status: Recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: Tianjin Medical University
• Contact: Xiaomin Zhang, M.D.
• Phone: +86-13920023990
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Uveitis

Intervention

Drug:
• Acyclovir

Locations

Country	Name	City	State
China	Tianjin Medical University Eye Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Xiaomin Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants who experience a recurrence	Number of participants who experience a recurrence	12 weeks
Secondary	Length of time to quiescence	Length of time to quiescence	12 weeks
Secondary	Ability to taper concomitant immunosuppressive medications	Ability to taper concomitant immunosuppressive medications	12 weeks
Secondary	Number and severity of systemic and ocular toxicities and adverse events	Number and severity of systemic and ocular toxicities and adverse events	12 weeks