Status:
RECRUITING
Clinical Study of High Concentration Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
Lead Sponsor:
Tianjin Medical University
Conditions:
Cytomegalovirus Retinitis
Ganciclovir Eye Drops
Eligibility:
All Genders
2-80 years
Phase:
EARLY_PHASE1
Brief 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 infor...
Eligibility Criteria
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 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 Criteria:
-
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;
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05911503
Start Date
July 1 2023
End Date
June 30 2027
Last Update
June 23 2023
Active Locations (1)
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1
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China, 300000