Cytomegalovirus RetinitisEarly Phase 1NCT05911503
Clinical Study of High Concentration Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
A Early Phase 1 study testing 2% Ganciclovir Eye Drops in people with Cytomegalovirus Retinitis and Ganciclovir Eye Drops, run by Tianjin Medical University at 1 site in China.
Trial summary
Clinical study of high concentration ganciclovir eye drops in the treatment of cytomegalovirus retinitis Read more about this study
- Who is it for?
- Ages 2 to 80 years
- Conditions the study is for
- Cytomegalovirus Retinitis, Ganciclovir Eye Drops
- What is being tested?
- 2% Ganciclovir Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 30 Jun 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300000
xiaomin Zhang, +8613920023990, xiaomzh@126.com
About this study
Official title: A Clinical Study of High Concentration(2%) Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
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.
- Conditions
- Cytomegalovirus Retinitis, Ganciclovir Eye Drops
- Being tested
- 2% Ganciclovir Eye Drops
- Medical subject headings
- Cytomegalovirus Retinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Ganciclovir Eye DropsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 2% Ganciclovir Eye Drops therapy Group | Experimental | 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 Receives: Drug: 2% Ganciclovir Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fundus lesions
The size changes of fundus lesions after medication are recorded
Measured: 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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus RetinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaomin Zhang, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911503
- Sponsor's protocol ID
- 2023KY-23
- Status last verified
- Jun 2023
- First submitted
- 4 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided