NCT05911503

Clinical Study of High Concentration Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis

A Clinical Study of High Concentration(2%) Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Tianjin Medical University · Academic / Other
• Sex: All
• Age: 2 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Clinical study of high concentration ganciclovir eye drops in the treatment of cytomegalovirus retinitis

Detailed description

Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the use of 2% Ganciclovir Eye Drops, its potential risks and benefits. This is a monocencer, single arm, prospective study. The experimental group is: 2% Ganciclovir Eye Drops therapy group. Administration method and dose adjustment: 2% ganciclovir eye drops, 10 times / day for two weeks, 8 times/day for two weeks, 6 times/day for two weeks, 4 times/day for more than six weeks. According to best corrected visual acuity (BCVA), intraocular pressure, corneal abrasion, anterior chamber and vitreous inflammation, optical coherence tomography (OCT), Ultra wide angle fundus image and so on. The investigators evaluate the effects of 2% Ganciclovir Eye Drops in treatment of cytomegalovirus retinitis.

Conditions

• Cytomegalovirus Retinitis
• Ganciclovir Eye Drops

Interventions

Type	Name	Description
DRUG	2% Ganciclovir Eye Drops	Administration method and dosage adjustment: 2% ganciclovir eye drops, 10 times/day for two weeks, 8 times/day for two weeks, 6 times/day for two weeks, 4 times/day for more than 6 weeks

Timeline

• Start date: 2023-07-01
• Primary completion: 2027-06-01
• Completion: 2027-06-30
• First posted: 2023-06-22
• Last updated: 2023-06-23

Locations

1 site across 1 country: China