Clinical Study of High Concentration Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis

Launched by TIANJIN MEDICAL UNIVERSITY · Jun 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for a serious eye condition called cytomegalovirus retinitis, which can cause vision loss. The treatment being tested is high concentration ganciclovir eye drops. Researchers want to see if these eye drops can help patients who have this condition and are at risk of complications from other treatments, especially those with weakened immune systems, like patients who have had stem cell transplants or those living with AIDS.

To participate in this study, individuals must be between the ages of 2 and 80 and agree to take part by signing consent forms. Eligible participants include those who have cytomegalovirus retinitis and meet specific health criteria, such as having low white blood cell or platelet counts. If you decide to join, you will receive the eye drops and be monitored by healthcare professionals. This trial is currently recruiting participants, so if you or someone you know might qualify, it could be an opportunity to help advance treatment options for this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients voluntarily participate in studies and sign informed consent forms
• • 2. Ages 2-80 years (with cut-off values) male and female
• • 3. 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
• • 1. The presence of refractive interstitial opacification affects fundus observation;
• • 2. Intravitreal ganciclovir or sodium phosformate injections were performed within 1 week prior to baseline;
• • 3. 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
• • 1. Severe neutropenia (\<0.5×10\^9) or severe thrombocytopenia (\< 25× 10\^9/L);
• • 2. Other investigators judged patients who were not suitable for enrollment;