Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 2 to 80

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

PhaseEarly Phase 1
Study typeInterventional
Ages2 Years to 80 Years
SexAll
Enrollment15 (estimated)
SponsorTianjin Medical University
Academic / other
Locations1 site (Tianjin, Tianjin Municipality)
StatusRecruiting
StartedJuly 1, 2023
Main results expectedJune 1, 2027
Study endsJune 30, 2027
Registry record updatedJune 23, 2023
Trial IDNCT05911503 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

  • Tianjin Medical University Eye Hospital
    Tianjin, Tianjin Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.