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

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.

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Key information

Conditions

Infection Viral Amino Acid Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Genetic Diseases, Inborn Infections Metabolic Diseases Metabolism, Inborn Errors Mitochondrial Diseases Multiple Acyl Coenzyme A Dehydrogenase Deficiency Nutritional and Metabolic Diseases Panuveitis Uveal Diseases Uveitis Uveitis, Posterior Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ganciclovir

Drug

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.

Primary outcomes

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.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Aier School of Ophthalmology, Central South University

Other

Registry information

Official study title

A Prospective, Non-randomized, Non-controlled Trial: Initial Intravitreal Injection of High-dose Ganciclovir for Cytomegalovirus Retinitis in HIV-negative Patients

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Jul 26, 2018
Registry last updated: Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed