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

Sponsor

Aier School of Ophthalmology, Central South University (Other)

Overall Status

Completed

CT.gov ID

NCT03598452

Collaborator

(none)

Enrollment

Arm

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection Viral Uveitis, Posterior	Drug: Ganciclovir	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

CMV-DNA load in aqueous humor [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 Outcome Measures

Visual function [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 [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