RecruitingEarly Phase 1NCT05911503

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

Sponsor

Tianjin Medical University

Enrollment

15 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Cytomegalovirus Retinitis Ganciclovir Eye Drops

Summary

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

Eligibility

Min Age: 2 YearsMax Age: 80 Years

Inclusion Criteria3

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.

Exclusion Criteria7

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.
General condition
Severe neutropenia (<0.5×10\^9) or severe thrombocytopenia (< 25× 10\^9/L);
Other investigators judged patients who were not suitable for enrollment;

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Interventions

DRUG2% 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

Locations(1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China

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NCT05911503