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Recruiting NCT05911503

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

Early Phase I Interventional Cytomegalovirus Retinitis Ganciclovir Eye Drops

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 2% Ganciclovir Eye Drops.
Who it may be relevant to
Registry conditions: Cytomegalovirus Retinitis, Ganciclovir Eye Drops. Basic parameters: 2 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug 2% Ganciclovir Eye Drops
    Administration method and dosage 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 6 weeks

Primary outcome measures

  • Fundus lesions [Time frame: 24 weeks]
Secondary outcome measures (1)
  • Change In LogMAR Best Corrected Visual Acuity (BCVA)From Baseline to Each visit [Time frame: 24 weeks]

Eligibility criteria

Inclusion criteria

  • Patients voluntarily participate in studies and sign informed consent forms
  • Ages 2-80 years (with cut-off values) male and female
  • 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
  • The presence of refractive interstitial opacification affects fundus observation;
  • Intravitreal ganciclovir or sodium phosformate injections were performed within 1 week prior to baseline;
  • 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
  • Severe neutropenia (<0.5×10\^9) or severe thrombocytopenia (< 25× 10\^9/L);
  • Other investigators judged patients who were not suitable for enrollment;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University Eye Hospital — Tianjin

Identifiers

NCT: NCT05911503 · 2023KY-23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗