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

Primary Purpose

Cytomegalovirus Retinitis, Ganciclovir Eye Drops

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
2% Ganciclovir Eye Drops
Sponsored by
Tianjin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis

Eligibility Criteria

2 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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;

Sites / Locations

  • Tianjin Medical University Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

2% Ganciclovir Eye Drops therapy Group

Arm Description

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

Outcomes

Primary Outcome Measures

Fundus lesions
The size changes of fundus lesions after medication are recorded

Secondary Outcome Measures

Change In LogMAR Best Corrected Visual Acuity (BCVA)From Baseline to Each visit
The size changes of fundus lesions after medication are recorded

Full Information

First Posted
June 4, 2023
Last Updated
June 21, 2023
Sponsor
Tianjin Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05911503
Brief Title
Clinical Study of High Concentration Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
Official Title
A Clinical Study of High Concentration(2%) Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, Ganciclovir Eye Drops

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2% Ganciclovir Eye Drops therapy Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
2% Ganciclovir Eye Drops
Intervention Description
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
Primary Outcome Measure Information:
Title
Fundus lesions
Description
The size changes of fundus lesions after medication are recorded
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change In LogMAR Best Corrected Visual Acuity (BCVA)From Baseline to Each visit
Description
The size changes of fundus lesions after medication are recorded
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaomin Zhang
Phone
+8613920023990
Email
xiaomzh@126.com
Facility Information:
Facility Name
Tianjin Medical University Eye Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaomin Zhang
Phone
+8613920023990
Email
xiaomzh@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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