About this trial
Clinical study of high concentration ganciclovir eye drops in the treatment of cytomegalovirus retinitis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients voluntarily participate in studies and sign informed consent forms
Ages 2-80 years (with cut-off values) male and female
One of the following is true (1)In patients with cytomegalovirus retinitis after hematopoietic stem cell transplantation/cord blood transplantation, the white blood cell count is less than 4× 10^9/L, and the platelet count ranges are 25× 10^9/L≤ PLT<100×10^9/L,Intravitreal injection carries a greater risk of infection and bleeding, and is unable to administer systemic medication due to the bone marrow suppression of antiviral drugs, or systemic medication for severe CMV retinitis cannot be well controlled; (2)In patients with CMVR with AIDS, the CD4+ T cell count is less than 100/μl, there is a great risk of infection with intravitreal injection, and the systemic medication of severe CMV retinitis cannot be well controlled.
Disqualifiers
Eye condition
The presence of refractive interstitial opacification affects fundus observation;
Intravitreal ganciclovir or sodium phosformate injections were performed within 1 week prior to baseline;
Other diseases that can affect visual function such as syphilis-related eye diseases, acute retinal necrosis, congenital glaucoma, congenital corneal lesions, congenital macular degeneration, etc.
Trial design
Single group
Treatments tested in this trial
2% Ganciclovir Eye Drops
DrugAdministration 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
Treatment groups
Trial outcomes
Primary outcomes
Fundus lesions
The size changes of fundus lesions after medication are recorded
Secondary outcomes
Change In LogMAR Best Corrected Visual Acuity (BCVA)From Baseline to Each visit
The size changes of fundus lesions after medication are recorded
Sponsors and contacts
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