Status:

RECRUITING

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

Lead Sponsor:

Tianjin Medical University

Conditions:

Cytomegalovirus Retinitis

Ganciclovir Eye Drops

Eligibility:

All Genders

2-80 years

Phase:

EARLY_PHASE1

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 infor...

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;

Key Trial Info

Start Date :

July 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2027

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT05911503

Start Date

July 1 2023

End Date

June 30 2027

Last Update

June 23 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China, 300000

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