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

Cytomegalovirus Retinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05911503
• Other study ID #: 2023KY-23
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 1, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: June 2023
• Source: Tianjin Medical University
• Contact: xiaomin Zhang
• Phone: +8613920023990
• Email: xiaomzh[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 30, 2027
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• Retinitis

Intervention

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

Locations

Country	Name	City	State
China	Tianjin Medical University Eye Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fundus lesions	The size changes of fundus lesions after medication are recorded	24 weeks
Secondary	Change In LogMAR Best Corrected Visual Acuity (BCVA)From Baseline to Each visit	The size changes of fundus lesions after medication are recorded	24 weeks