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

NCT05911503 | Recruiting Early Phase 1

• 1 other identifier: 2023KY-23
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cytomegalovirus Retinitis; Ganciclovir Eye Drops

Outcome Measures

Primary Outcomes (1)

• Fundus lesions

  The size changes of fundus lesions after medication are recorded

  24 weeks

Secondary Outcomes (1)

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

  24 weeks

Study Arms (1)

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

Drug: 2% Ganciclovir Eye Drops

Interventions

2% Ganciclovir Eye Drops DRUG

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

2% Ganciclovir Eye Drops therapy Group

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tianjin Medical University: lead

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Retinitis

Condition Hierarchy (Ancestors)

Eye Infections, Viral; Eye Infections; Infections; Cytomegalovirus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Eye Diseases; Retinitis; Retinal Diseases

Central Study Contacts

xiaomin Zhang

CONTACT

+8613920023990; xiaomzh@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,MD,PhD

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 22, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 23, 2023

Record last verified: 2023-06

Locations

CN (1)