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Trial record 34 of 36 for:    "Retinitis" | "Ganciclovir triphosphate"

High-dose Intravitreal Injection of Ganciclovir for the Treatment of CMVR in HIV-negative Patients

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ClinicalTrials.gov Identifier: NCT03598452
Recruitment Status : Completed
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Aier School of Ophthalmology, Central South University

Tracking Information
First Submitted Date  ICMJE July 4, 2018
First Posted Date  ICMJE July 25, 2018
Last Update Posted Date July 25, 2018
Actual Study Start Date  ICMJE January 2014
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
CMV-DNA load in aqueous humor [ Time Frame: Once a week. From the date of the first IVG until the date in which the CMV-DNA load turned undectable, assessed up to 10 weeks. ]
The load of CMV-DNA level in aqueous humor was detected by means of real-time polymerase chain reaction (PCR). The aqueous humor was obtained before the IVG.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
  • Visual function [ Time Frame: Once a week. From the date of the first IVG until the date in which the CMV-DNA load turned undectable, assessed up to 10 weeks. ]
    Best corrected visual acuity (BCVA) measured using a decimal chart
  • Occurrence of IVG-related complications [ Time Frame: Once a week. From the date of the first IVG until the date in which the CMV-DNA load turned undectable, assessed up to 10 weeks. ]
    The occurence of IVG-related complications
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-dose Intravitreal Injection of Ganciclovir for the Treatment of CMVR in HIV-negative Patients
Official Title  ICMJE A Prospective, Non-randomized, Non-controlled Trial: Initial Intravitreal Injection of High-dose Ganciclovir for Cytomegalovirus Retinitis in HIV-negative Patients
Brief Summary This prospective, non-randomized, non-controlled clinical trial was conducted to examine the clinical outcomes achieved by using initial high-dose intravitreal ganciclovir injections of ganciclovir in treating cytomegalovirus (CMV) retinitis in patients without human immunodeficiency virus (HIV) infection.
Detailed Description Cytomegalovirus retinitis (CMVR) is a serious vision-threatening disease. Intravitreal antiviral drug delivery was used as first-line treatment in several studies when systematic injection has been ruled out. The reported dose of intravitreal injections of ganciclovir (IVG) varied from 200 μg/0.1 ml to 5mg/0.1 ml in patients with AIDS. There was no consensus on the dose of ganciclovir in the treatment of CMVR in HIV-negative patients. Previous work showed the safety and the efficacy of 1mg IVG. The investigators proposed that a higher dose of ganciclovir (6mg/0.1ml) for the first injection followed by lower dose for maintenance may indicate a better result. Therefore, this study was performed to evaluate the therapeutic effect and safety of initial high-dose IVG for CMVR in HIV-negative patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Infection Viral
  • Uveitis, Posterior
Intervention  ICMJE Drug: Ganciclovir
Intravitreal Injection of Ganciclovir (IVG) was conducted in a week interval. The initial dose was 6mg/0.1ml at the first injection and it was reduced to 4.5mg/0.1ml at the second time; 3mg/0.1ml of IVG was maintained until the CMV could not be detected in aqueous humor.
Study Arms  ICMJE Experimental: High dose of ganciclovir group
IVG was conducted in a week interval. The initial dose was 6mg/0.1ml at the first injection and it was reduced to 4.5mg/0.1ml at the second time; 3mg/0.1ml of IVG was maintained until the CMV could not be detected in aqueous humor.
Intervention: Drug: Ganciclovir
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2018)
33
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with CMVR by ophthalmological examination
  • Positive CMV-DNA in aqueous humor approved by real-time PCR.
  • HIV-negative.

Exclusion Criteria:

  • Diabetic retinopathy,
  • Glaucoma.
  • Optic neuritis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03598452
Other Study ID Numbers  ICMJE SHIRB2018017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: The accurate CMV-DNA load and its change will be shared in the published paper.
Responsible Party Aier School of Ophthalmology, Central South University
Study Sponsor  ICMJE Aier School of Ophthalmology, Central South University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wensheng Li, Doctor Shanghai Aier Eye Hospital
PRS Account Aier School of Ophthalmology, Central South University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP