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A Clinical Trial of Acyclovir for Viral Uveitis

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ClinicalTrials.gov Identifier: NCT03389191
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Xiaomin Zhang, Tianjin Medical University

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

Condition or disease Intervention/treatment Phase
Uveitis Drug: Acyclovir Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial of Oral Acyclovir in Viral Uveitis
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with Viral Uveitis
Oral acyclovir 100 mg three times a day (TID).
Drug: Acyclovir



Primary Outcome Measures :
  1. Global assessment of ocular status [ Time Frame: 12 weeks ]
    Global assessment of ocular status


Secondary Outcome Measures :
  1. Best Corrected Visual Acuity in logMAR [ Time Frame: 12 weeks ]
    Best Corrected Visual Acuity in logMAR



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Age between 18 and above. 2. Chronic, vision threatening viral uveitis. 3. Patients can't tolerate hormone therapy bacause of drug side effects. 4. Consent to undergo anterior chamber tap and give aqueous for the study. 5. Able to undergo relevant tests. 6. Able to come for subsequent follow-up visits. 7. Ability to provide informed consent.

Exclusion Criteria:

  • 1. Patients who are allergic to ayclovir. 2. Immunocompromised patients 3. Positive for HIV, Hep B and Hep C 4. Not keen on participating in the study 5. Patients who are incapable, either by law or mental state, of giving consents in their own right.

    6. Patients who are either unable or unwilling to keep scheduled appointments and adhere to the other aspects of the protocol.

    7. Patients who are pregnant or breastfeeding. 8. Any other specified reason as determined by the clinical investigator.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389191


Contacts
Contact: Xiaomin Zhang, M.D. +86-13920023990
Contact: Jing Yang +86-13002215386

Locations
China, Tianjin
Tianjin Medical University Eye Hospital Recruiting
Tianjin, Tianjin, China, 300000
Sponsors and Collaborators
Xiaomin Zhang
Investigators
Study Director: Xiaomin Zhang, M.D. Tianjin Medical University Eye Hospital

Responsible Party: Xiaomin Zhang, MD, PhD, Tianjin Medical University
ClinicalTrials.gov Identifier: NCT03389191     History of Changes
Other Study ID Numbers: 2017KY-07
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study protocol,statistical analysis plan,informed consent form and clinical study report are to be shared with other researchers.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The data will become available starting 6 months after publication.

Studies a U.S. FDA-regulated Drug Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Uveitis
Uveal Diseases
Eye Diseases
Acyclovir
Antiviral Agents
Anti-Infective Agents