Treatment outcomes of reduced-dose ganciclovir injection (reduced-dose IVT ganciclovir)
Study ID: TCTR20160316001
Current status: Completed
Last Updated: March 16, 2016
Tracking Information
Date of Registration in Primary Registry: March 16, 2016
Date of First Enrollment: November 16, 2009 (Actual)
Target Sample Size: 60
Last Updated Date: March 16, 2016
Primary Outcome(s):
  • Outcome name: Resolution of CMVR lesion
       Metric/method of measurement: Indirect ophthalmoscopic examination
       Time point: 24 weeks after medication
       Safety Issue?: No


  • Key Secondary Outcomes:
  • Outcome name: change of visual acuity
       Metric/method of measurement: snellen visual acuity
       Time point: at resolution of lesion
       Safety Issue?: No


  • Outcome name: incidence of complication
       Metric/method of measurement: clinical observation
       Time point: during treatment
       Safety Issue?: No


  • Descriptive Information
    Public Title: Treatment outcomes of reduced-dose ganciclovir injection
    Scientific Title: Efficacy and safety of reduced-dose intravitreal ganciclovir for treatment of cytomegalovirus retinitis (CMVR) (reduced-dose IVT ganciclovir)
    Brief Summary: The prospective observational study evaluated the efficacy of reduced-dose intravitreal ganciclovir injection as a treatment for cytomegalovirus retinitis. Subgroup analysis was performed between intravitreal ganciclovir alone and combination of intravenous and intravitreal ganciclovir
    Detailed Description:
    Study Design: Allocation: Non-randomized
    Control: N/A
    Study Endpoint Classification: Efficacy Study
    Intervention Model: Parallel
    Number of Groups: 2
    Masking: (Masked Roles: )
    Primary Purpose: Treatment
    Study Phase: N/A
    Health Condition(s) or Problem(s) Studied: CMVR lesion , visual acuity , intraocular pressure
    Study Groups:
  • Group: 1
  • Group Name: IVTG
    Descriptions: intravitreal injection of 2-mg ganciclovir every week for 4 weeks and then every 2 weeks until resolution of CMVR lesion
  • Group: 2
  • Group Name: IVG+IVTG
    Descriptions: intravenous injection of ganciclovir (10mg/kg/day) for 2 weeks then followed by intravitreal injection of 2-mg ganciclovir every week for 4 weeks and then every 2 weeks until resolution of CMVR lesion
    Recruitment Information
    Recruitment Status: Completed
    Estimated Enrollment: 60
    Study Start Date (First enrollment): November 16, 2009
    Primary Completion Date: September 16, 2012
    Inclusion Criteria:
    Inclusion Criteria
    Gender: Both
    Age Limit: Minimum 18 Years : Maximum 0 N/A (No limit)
    Patients with cytomegalovirus retinitis
    Exclusion Criteria
    patients with concomitant retinal inflammation
    patients who previously treated with ganciclovir
    Accept Healthy Volunteers: No
    Countries of Recruitment Thailand
    Contact for Public Queries:
    Contact for Public Query's Name: Pitipol Choopong
    Degree: MD
    Phone: 66868978654
    Email: pitipol@gmail.com
    Postal Address: 114/6 Phra Arthit road
    State/Province: Bangkok        Postal Code: 10200
    Country: Thailand
    Administrative Information
    Primary Registry Site: Thai Clinical Trials Registry
    Trial Identification Number: TCTR20160316001
    Secondary Identifying Numbers: Nil known
    Source(s) of Monetary or Material Supports: Siriraj Development Research Fund (managed by Routine to Research:R2R)
    Study Primary Sponsor: Siriraj Development Research Fund (managed by Routine to Research:R2R)
    Study Secondary Sponsor: 1.) none
    Contact for Scientific Queries:
    Contact for Scientific Query's Name: Pitipol Choopong
    Degree: MD
    Phone: 66868978654
    Email: pitipol@gmail.com
    Postal Address: 114/6 Phra Arthit road
    State/Province: Bangkok        Postal Code: 10200
    Country: Thailand
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