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This project is designed to test the hypothesis that acyclovir is clinically useful for patients with refractory viral uveitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Viral Uveitis | Experimental | Oral acyclovir 100 mg three times a day (TID). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acyclovir | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean and median change in best corrected visual acuity in logMAR | Mean and median change in best corrected visual acuity in logMAR | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experience a recurrence | Number of participants who experience a recurrence | 12 weeks |
| Length of time to quiescence | Length of time to quiescence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaomin Zhang, M.D. | Contact | +86-13920023990 | ||
| Jing Yang | Contact | +86-13002215386 |
| Name | Affiliation | Role |
|---|---|---|
| Xiaomin Zhang, M.D. | Tianjin Medical University Eye Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Eye Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
The study protocol,statistical analysis plan,informed consent form and clinical study report are to be shared with other researchers.
The data will become available starting 6 months after publication.
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.
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000212 | Acyclovir |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| 12 weeks |
| Ability to taper concomitant immunosuppressive medications | Ability to taper concomitant immunosuppressive medications | 12 weeks |
| Number and severity of systemic and ocular toxicities and adverse events | Number and severity of systemic and ocular toxicities and adverse events | 12 weeks |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |