A Clinical Trial of Acyclovir for Viral Uveitis

• Sponsor: Xiaomin Zhang (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03389191
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 59
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• 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: Jan 1, 2017
• Actual Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mean and median change in best corrected visual acuity in logMAR [12 weeks]

   Mean and median change in best corrected visual acuity in logMAR

Secondary Outcome Measures

1. Number of participants who experience a recurrence [12 weeks]

   Number of participants who experience a recurrence

2. Length of time to quiescence [12 weeks]

   Length of time to quiescence

3. Ability to taper concomitant immunosuppressive medications [12 weeks]

   Ability to taper concomitant immunosuppressive medications

4. Number and severity of systemic and ocular toxicities and adverse events [12 weeks]

   Number and severity of systemic and ocular toxicities and adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tianjin Medical University Eye Hospital	Tianjin	Tianjin	China	300000

Sponsors and Collaborators

• Xiaomin Zhang

Investigators

• Study Director: Xiaomin Zhang, M.D., Tianjin Medical University Eye Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaomin Zhang, MD, PhD, Principal Investigator, Clinical Professor, Tianjin Medical University
• ClinicalTrials.gov Identifier: NCT03389191
• Other Study ID Numbers: 2017KY-07
• First Posted: Jan 3, 2018
• Last Update Posted: Apr 5, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Uveitis; Acyclovir

Study Results

No Results Posted as of Apr 5, 2021