Clinical trial NCT05911503: Clinical Study of High Concentration Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
Official title: A Clinical Study of High Concentration(2%) Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Cytomegalovirus Retinitis
Ganciclovir Eye Drops
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 15
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical study of high concentration ganciclovir eye drops in the treatment of cytomegalovirus retinitis

Detailed description: Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the use of 2% Ganciclovir Eye Drops, its potential risks and benefits. This is a monocencer, single arm, prospective study. The experimental group is: 2% Ganciclovir Eye Drops therapy group.

Administration method and dose adjustment: 2% ganciclovir eye drops, 10 times / day for two weeks, 8 times/day for two weeks, 6 times/day for two weeks, 4 times/day for more than six weeks.

According to best corrected visual acuity (BCVA), intraocular pressure, corneal abrasion, anterior chamber and vitreous inflammation, optical coherence tomography (OCT), Ultra wide angle fundus image and so on. The investigators evaluate the effects of 2% Ganciclovir Eye Drops in 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;

Primary outcomes:
measure: Fundus lesions
timeFrame: 24 weeks
Secondary outcomes:
measure: Change In LogMAR Best Corrected Visual Acuity (BCVA)From Baseline to Each visit
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin
Study officials:
References: