Actively Recruiting
Clinical Study of High Concentration 2% Ganciclovir Eye Drops for Cytomegalovirus Retinitis Treatment
Led by Tianjin Medical University · Updated on 2023-06-23
15
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of high concentration 2% Ganciclovir Eye Drops in treating cytomegalovirus retinitis, a serious eye infection. The study is a single-center, prospective trial where patients diagnosed with this condition are carefully monitored. The study follows ethical guidelines, and participants provide informed consent after being fully informed about the treatment and potential risks. Participants receive 2% Ganciclovir Eye Drops with a specific dosing schedule: 10 times per day for the first two weeks, then 8 times per day for the following two weeks, 6 times per day for the next two weeks, and finally 4 times per day for more than six weeks. The study focuses on one experimental group using this eye drop therapy. Throughout the study, researchers assess various eye health measures including visual acuity, eye pressure, corneal condition, inflammation, optical coherence tomography, and wide-angle fundus imaging. The main outcome measured is the condition of fundus lesions over 24 weeks, along with changes in best corrected visual acuity. Safety and effectiveness are monitored during this period, with the total participation lasting up to 24 weeks.
CONDITIONS
Brief Title
Clinical Study of High Concentration Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must voluntarily agree to participate and sign informed consent forms
- Ages between 2 and 80 years, any gender
- Patients with cytomegalovirus retinitis after stem cell or cord blood transplantation with low white blood cell count and platelet count in specified ranges, unable to use systemic antiviral drugs or intravitreal injection due to risks
- Patients with cytomegalovirus retinitis related to AIDS with low CD4+ T cell count and high risk from intravitreal injection, where systemic medication is not well controlled
You will not qualify if you...
- Eye conditions that interfere with fundus observation, such as refractive interstitial opacification
- Intravitreal ganciclovir or sodium phosphonate injections within 1 week before the study starts
- Other eye diseases affecting vision like syphilis-related eye diseases, acute retinal necrosis, congenital glaucoma, corneal lesions, or macular degeneration
- Severe neutropenia (very low neutrophil count) or severe thrombocytopenia (very low platelet count)
- Any other conditions judged by investigators as unsuitable for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 10 weeks
Participants receive 2% Ganciclovir Eye Drops with dosage adjustments over time to treat cytomegalovirus retinitis.
Regular visits to monitor treatment effects and adjust dosage
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
X
xiaomin Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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