An interventional study of Ganciclovir in Infection Viral and Uveitis, Posterior, sponsored by Aier School of Ophthalmology, Central South University. Completed. Per ClinicalTrials.gov, last updated 2018-07-26.
Sponsored by Aier School of Ophthalmology, Central South University · Not applicable, Interventional, and Treatment
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.
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.
656 studies on the registry are indexed under Virus Diseases; 85 are open to participants now.
This study's enrollment of 33 is below the median of 100 across 464 interventional studies indexed under Virus Diseases.
Browse Virus Diseases studies →Aier School of Ophthalmology, Central South University is the lead sponsor of 18 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
CMV-DNA load in aqueous humor
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.
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.
Visual function
Best corrected visual acuity (BCVA) measured using a decimal chart
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.
Occurrence of IVG-related complications
The occurence 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.
No study locations are listed for this record.
Plan to share: Undecided — The accurate CMV-DNA load and its change will be shared in the published paper.
Ran from Jan 2014 to primary completion in Jan 2018, 48 months.
Of 42 non-industry interventional studies with no phase under Virus Diseases, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 42. This study's 48 months is above that.
Counting every sponsor, half of 61 studies reached it within 17 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ganciclovir
Aier School of Ophthalmology, Central South University