High concentration ganciclovir eye drops for treating cytomegalovirus retinitis

A Clinical Study of High Concentration(2%) Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis

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
• Enrollment: 15 (estimated)
• Ages: 2 Years to 80 Years
• Sex: All
• Sponsor: Tianjin Medical University (Academic / other)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT05911503 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 2-80 with cytomegalovirus retinitis who cannot receive systemic antiviral medications due to severe immunosuppression.

Not a fit: Patients with other significant eye conditions or those who do not meet the inclusion criteria may not benefit from this 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 performed: While there have been studies on ganciclovir for cytomegalovirus retinitis, this specific approach with high concentration eye drops is relatively novel.

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;

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Medical University Eye Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: xiaomin Zhang

Conditions Cytomegalovirus Retinitis; Ganciclovir Eye Drops