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

Aier School of Ophthalmology, Central South University

Status: Completed

Conditions: Uveitis, Posterior; Infection Viral

Treatments: Drug: Ganciclovir

Study type: Interventional

Funder types: Other

Identifiers

NCT03598452

SHIRB2018017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

High dose of ganciclovir group

Experimental group

Description:

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.

Treatment:

Drug: Ganciclovir