NCT05911503 Clinical Study of High Concentration Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
| NCT ID | NCT05911503 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Tianjin Medical University |
| Condition | Cytomegalovirus Retinitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2023-07-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Clinical study of high concentration ganciclovir eye drops in the treatment of cytomegalovirus retinitis
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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05911503 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 80 Years, studying Cytomegalovirus Retinitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05911503 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05911503 currently recruiting?
Yes, NCT05911503 is actively recruiting participants. Contact the research team at xiaomzh@126.com for enrollment information.
Where is the NCT05911503 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT05911503 clinical trial?
NCT05911503 is sponsored by Tianjin Medical University. The trial plans to enroll 15 participants.