High concentration ganciclovir eye drops for treating cytomegalovirus retinitis
Official title: A Clinical Study of High Concentration(2%) Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
Run by Tianjin Medical University · NCT05911503 · Data updated 2026-11-12
This study is testing if 2% ganciclovir eye drops can help people with cytomegalovirus retinitis improve their vision and eye health.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years to 80 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Tianjin Medical University Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | July 1, 2023 |
| Main results expected | June 1, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | June 23, 2023 |
| Trial ID | NCT05911503 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 2-80 with cytomegalovirus retinitis who cannot receive systemic antiviral medications due to severe immunosuppression.
✕Probably not a fit
Patients with other significant eye conditions or those who do not meet the inclusion criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study evaluates the effectiveness of 2% ganciclovir eye drops in treating cytomegalovirus retinitis. It is a monocentric, single-arm, prospective study where patients will receive the eye drops at varying frequencies over a period of six weeks. The study aims to assess the treatment's impact on visual acuity, intraocular pressure, and other ocular health indicators. All participants will provide informed consent and undergo thorough evaluations throughout the study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from cytomegalovirus retinitis.
How similar studies have gone: While there have been studies on ganciclovir for cytomegalovirus retinitis, this specific approach with high concentration eye drops is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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;
Where it's running
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Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Study coordinator: xiaomin Zhang
- Email: xiaomzh@126.com
- Phone: +8613920023990
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.