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RecruitingNCT05911503Updated Jun 23, 2023

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

An Early Phase 1 interventional study of 2% Ganciclovir Eye Drops in Cytomegalovirus Retinitis and Ganciclovir Eye Drops, sponsored by Tianjin Medical University. Recruiting at 1 site in China. Open to participants aged 2 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-23.

Sponsored by Tianjin Medical University · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
2 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cytomegalovirus Retinitis
  • Ganciclovir Eye Drops
03

In context

Cytomegalovirus Retinitis

64 studies on the registry are indexed under Cytomegalovirus Retinitis; 2 are open to participants now.

This study's planned enrollment of 15 is below the median of 106 across 38 interventional studies indexed under Cytomegalovirus Retinitis.

Browse Cytomegalovirus Retinitis studies →

Lead sponsor

Tianjin Medical University is the lead sponsor of 49 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients voluntarily participate in studies and sign 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 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 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

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;
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    2% Ganciclovir Eye Drops therapy Group

    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

    Drug: 2% Ganciclovir Eye Drops

Interventions

  • 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

06

What researchers measure

Primary outcomes

  1. Fundus lesions

    The size changes of fundus lesions after medication are recorded

    Time frame: 24 weeks

Secondary outcomes

  1. Change In LogMAR Best Corrected Visual Acuity (BCVA)From Baseline to Each visit

    The size changes of fundus lesions after medication are recorded

    Time frame: 24 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2023; primary completion for Jun 2027, 47 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2023
First posted
Jun 22, 2023
StartEst.
Jul 1, 2023
Primary completionEst.
Jun 1, 2027
CompletionEst.
Jun 30, 2027
Last update
Jun 23, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05911503
Lead sponsor
Tianjin Medical University
Responsible party
Xiaomin Zhang (Principal Investigator,MD,PhD, Tianjin Medical University) — Principal investigator
First posted
Jun 22, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jun 23, 2023

Study contacts

xiaomin Zhang
Contact
xiaomzh@126.com
+8613920023990

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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