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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of High Concentration(2%) Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
- ClinicalTrials.gov ID
- NCT05911503
- Acronym / sponsor ID
- 2023KY-23
- Conditions
- Cytomegalovirus Retinitis, Ganciclovir Eye Drops
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Tianjin Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2% Ganciclovir Eye Drops therapy Group | Experimental | Drug: 2% Ganciclovir Eye DropsAdministration 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 |
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Eye condition
- General condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% Ganciclovir Eye DropsAdministration 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 therapy Group |
Primary outcome
Fundus lesions
Time frame: 24 weeks
The size changes of fundus lesions after medication are recorded
1 secondary outcome
Change In LogMAR Best Corrected Visual Acuity (BCVA)From Baseline to Each visit
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Cytomegalovirus Retinitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiaomin Zhang (+8613920023990, xiaomzh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fundus lesions (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.