Infection Viral, Uveitis, Posterior
Conditions
Keywords
Cytomegalovirus retinopathy, High-dose, Ganciclovir, Intravitreal injection
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.
Interventions
DRUGGanciclovir
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.
Sponsors
Aier School of Ophthalmology, Central South University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed