Last updated: June 21, 2023
Sponsor: Tianjin Medical University
Overall Status: Active - Recruiting
Phase
1
Condition
Posterior Uveitis
Eye Disorders/infections
Cytomegalovirus Infections
Treatment
2% Ganciclovir Eye Drops
Clinical Study ID
NCT05911503
2023KY-23
Ages 2-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 afterhematopoietic stem cell transplantation/cord blood transplantation, the white bloodcell 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 andbleeding, and is unable to administer systemic medication due to the bone marrowsuppression of antiviral drugs, or systemic medication for severe CMV retinitis cannotbe well controlled; (2)In patients with CMVR with AIDS, the CD4+ T cell count is lessthan 100/μl, there is a great risk of infection with intravitreal injection, and thesystemic medication of severe CMV retinitis cannot be well controlled.
Exclusion
Exclusion Criteria:
- Eye condition
- The presence of refractive interstitial opacification affects fundus observation;
- Intravitreal ganciclovir or sodium phosformate injections were performed within 1week prior to baseline;
- Other diseases that can affect visual function such as syphilis-related eyediseases, acute retinal necrosis, congenital glaucoma, congenital corneallesions, 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;
Study Design
Total Participants: 15
Treatment Group(s): 1
Primary Treatment: 2% Ganciclovir Eye Drops
Phase: 1
Study Start date:
July 01, 2023
Estimated Completion Date:
June 30, 2027
Study Description
Connect with a study center
Tianjin Medical University Eye Hospital
Tianjin, Tianjin 300000
ChinaActive - Recruiting
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