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A Clinical Trial of Acyclovir for Viral Uveitis

X

Xiaomin Zhang

Status

Unknown

Conditions

Uveitis

Treatments

Drug: Acyclovir

Study type

Interventional

Funder types

Other

Identifiers

NCT03389191
2017KY-07

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Xiaomin Zhang, M.D.; Jing Yang

Data sourced from clinicaltrials.gov

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