A Clinical Trial of Acyclovir for Viral Uveitis

NCT ID: NCT03389191

Last Updated: 2021-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Uveitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with Viral Uveitis

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

Group Type EXPERIMENTAL

Acyclovir

Intervention Type DRUG

Interventions

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Acyclovir

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiaomin Zhang

OTHER

Sponsor Role lead

Responsible Party

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Xiaomin Zhang

MD, PhD, Principal Investigator, Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiaomin Zhang, M.D.

Role: STUDY_DIRECTOR

Tianjin Medical University Eye Hospital

Locations

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Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaomin Zhang, M.D.

Role: CONTACT

+86-13920023990

Jing Yang

Role: CONTACT

+86-13002215386

Other Identifiers

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2017KY-07

Identifier Type: -

Identifier Source: org_study_id

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