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

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

Study Overview

• Status: Recruiting
• Conditions: Cytomegalovirus Retinitis; Ganciclovir Eye Drops
• Intervention / Treatment: Drug: 2% Ganciclovir Eye Drops

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: xiaomin Zhang; Phone Number: +8613920023990; Email: xiaomzh@126.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Recruiting
      • Tianjin Medical University Eye Hospital
      • Contact: xiaomin Zhang; Phone Number: +8613920023990; Email: xiaomzh@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

5 patients with CMV retinitis who were unable to administer systemic and vitreous medications due to systemic conditions

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2% Ganciclovir Eye Drops therapy Group; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fundus lesions	The size changes of fundus lesions after medication are recorded	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tianjin Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 4, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; Eye Diseases; Retinal Diseases; DNA Virus Infections; Herpesviridae Infections; Eye Infections; Eye Infections, Viral; Cytomegalovirus Infections; Retinitis; Cytomegalovirus Retinitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Pharmaceutical Solutions; Ophthalmic Solutions; Ganciclovir; Ganciclovir triphosphate
• Other Study ID Numbers: 2023KY-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No