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

Infection Viral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03598452
• Other study ID #: SHIRB2018017
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: June 2018

Study information

• Verified date: July 2018
• Source: Aier School of Ophthalmology, Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• Infection Viral
• Uveitis
• Uveitis, Posterior
• Virus Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aier School of Ophthalmology, Central South University

References & Publications (3)

Jeon S, Lee WK, Lee Y, Lee DG, Lee JW. Risk factors for cytomegalovirus retinitis in patients with cytomegalovirus viremia after hematopoietic stem cell transplantation. Ophthalmology. 2012 Sep;119(9):1892-8. doi: 10.1016/j.ophtha.2012.03.032. Epub 2012 May 30. — View Citation

Kuo IC, Kempen JH, Dunn JP, Vogelsang G, Jabs DA. Clinical characteristics and outcomes of cytomegalovirus retinitis in persons without human immunodeficiency virus infection. Am J Ophthalmol. 2004 Sep;138(3):338-46. — View Citation

Miao H, Tao Y, Jiang YR, Li XX. Multiple intravitreal injections of ganciclovir for cytomegalovirus retinitis after stem-cell transplantation. Graefes Arch Clin Exp Ophthalmol. 2013 Jul;251(7):1829-33. doi: 10.1007/s00417-013-2368-6. Epub 2013 May 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Secondary	Visual function	Best corrected visual acuity (BCVA) measured using a decimal chart	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.
Secondary	Occurrence of IVG-related complications	The occurence 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.