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A Clinical Trial of Acyclovir for Viral Uveitis

Primary Purpose

Uveitis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Acyclovir

About this trial

This is an interventional treatment trial for Uveitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Tianjin Medical University Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with Viral Uveitis

Arm Description

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

Outcomes

Primary Outcome Measures

Mean and median change in best corrected visual acuity in logMAR

Secondary Outcome Measures

Number of participants who experience a recurrence

Length of time to quiescence

Ability to taper concomitant immunosuppressive medications

Number and severity of systemic and ocular toxicities and adverse events

Full Information

NCT ID

NCT03389191

First Posted

December 27, 2017

Last Updated

April 1, 2021

Sponsor

Xiaomin Zhang

1. Study Identification

Unique Protocol Identification Number

NCT03389191

Brief Title

A Clinical Trial of Acyclovir for Viral Uveitis

Official Title

A Clinical Trial of Oral Acyclovir in Viral Uveitis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 2017 (Actual)

Primary Completion Date

December 2019 (Actual)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xiaomin Zhang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uveitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with Viral Uveitis

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Acyclovir

Primary Outcome Measure Information:

Title

Mean and median change in best corrected visual acuity in logMAR

Description

Mean and median change in best corrected visual acuity in logMAR

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Number of participants who experience a recurrence

Description

Number of participants who experience a recurrence

Time Frame

12 weeks

Title

Length of time to quiescence

Description

Length of time to quiescence

Time Frame

12 weeks

Title

Ability to taper concomitant immunosuppressive medications

Description

Ability to taper concomitant immunosuppressive medications

Time Frame

12 weeks

Title

Number and severity of systemic and ocular toxicities and adverse events

Description

Number and severity of systemic and ocular toxicities and adverse events

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaomin Zhang, M.D.

Phone

+86-13920023990

First Name & Middle Initial & Last Name or Official Title & Degree

Jing Yang

Phone

+86-13002215386

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaomin Zhang, M.D.

Organizational Affiliation

Tianjin Medical University Eye Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Tianjin Medical University Eye Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300000

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The study protocol,statistical analysis plan,informed consent form and clinical study report are to be shared with other researchers.

IPD Sharing Time Frame

The data will become available starting 6 months after publication.

IPD Sharing 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.

Learn more about this trial

A Clinical Trial of Acyclovir for Viral Uveitis

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