Clinical Study of High Concentration Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis

Last updated: June 21, 2023
Sponsor: Tianjin Medical University
Overall Status: Active - Recruiting

Phase

1

Condition

Posterior Uveitis

Eye Disorders/infections

Cytomegalovirus Infections

Treatment

2% Ganciclovir Eye Drops

Clinical Study ID

NCT05911503
2023KY-23
  • Ages 2-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 afterhematopoietic stem cell transplantation/cord blood transplantation, the white bloodcell 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 andbleeding, and is unable to administer systemic medication due to the bone marrowsuppression of antiviral drugs, or systemic medication for severe CMV retinitis cannotbe well controlled; (2)In patients with CMVR with AIDS, the CD4+ T cell count is lessthan 100/μl, there is a great risk of infection with intravitreal injection, and thesystemic medication of severe CMV retinitis cannot be well controlled.

Exclusion

Exclusion Criteria:

  • Eye condition
  1. The presence of refractive interstitial opacification affects fundus observation;
  2. Intravitreal ganciclovir or sodium phosformate injections were performed within 1week prior to baseline;
  3. Other diseases that can affect visual function such as syphilis-related eyediseases, acute retinal necrosis, congenital glaucoma, congenital corneallesions, 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;

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: 2% Ganciclovir Eye Drops
Phase: 1
Study Start date:
July 01, 2023
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Tianjin Medical University Eye Hospital

    Tianjin, Tianjin 300000
    China

    Active - Recruiting

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