A Clinical Trial of Acyclovir for Viral Uveitis
Primary Purpose
Uveitis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acyclovir
Sponsored by
About this trial
This is an interventional treatment trial for Uveitis
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.
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
Mean and median change in best corrected visual acuity in logMAR
Secondary Outcome Measures
Number of participants who experience a recurrence
Number of participants who experience a recurrence
Length of time to quiescence
Length of time to quiescence
Ability to taper concomitant immunosuppressive medications
Ability to taper concomitant immunosuppressive medications
Number and severity of systemic and ocular toxicities and adverse events
Number and severity of systemic and ocular toxicities and adverse events
Full Information
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
No
Product Manufactured in and Exported from the U.S.
No
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
No
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
We'll reach out to this number within 24 hrs