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A multicenter randomized clinical controlled study on comparing the efficacy of intravitreal injection of different doses of ganciclovir in the treatment of cytomegalovirus retinitis

A multicenter randomized clinical controlled study on comparing the efficacy of intravitreal injection of different doses of ganciclovir in the treatment of cytomegalovirus retinitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115081
Enrollment
Unknown
Registered
2025-12-22
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus Retinitis

Interventions

Low-dose group:Induction period (two weeks):Inject 0.4 mg/0.1 mL of GCV into the vitreous cavity, twice a week. Maintenance period (four weeks):Inject 0.4 mg/0.1 mL of GCV into the vitreous cavity, on
High-dose group:Induction period (two weeks): Intravitreal injection of GCV at 2.0 mg/0.1 mL, twice a week Maintenance period (four weeks): Intravitreal injection of GCV at 2.0 mg/0.1 mL, once a week.

Sponsors

Beijing Chaoyang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with newly diagnosed or recurrent cases that meet the diagnostic criteria for CMVR; 2. Patients with no history of intravitreal injection of antiviral drugs within the past 3 months; 3. In the case of clinically diagnosed bilateral patients, the same treatment regimen should be applied to both eyes, and the eye that developed the disease first should be included in the study; 4. Patients who have signed the informed consent form and are willing to undergo follow - up according to the time requirements of the trial; 5). Patients aged 14 years or older, regardless of gender.

Exclusion criteria

Exclusion criteria: 1. The subjects refuse to undergo relevant examinations or treatments, or their general physical condition is poor and they cannot tolerate the treatment. 2. Patients with no light perception in vision, combined with retinal detachment or other eye diseases such as glaucoma or cataract. 3. Patients with opaque refractive media who cannot undergo relevant fundus examinations. 4. Patients who have hypersensitivity to any pharmaceutical preparations used in the research - related procedures, have contraindications, or cannot cooperate with the treatment. 5. Pregnant or breastfeeding women, or those planning to become pregnant during the study period (Female patients of child - bearing age must have a negative urine pregnancy test result within 28 days before starting the study treatment. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test). 6. Patients who have received other clinical trial drugs or device treatments (except for vitamins and minerals) within 3 months before baseline or within 5 half - lives (whichever is longer). 7. Patients with mental abnormalities.

Design outcomes

Primary

MeasureTime frame
Retinal lesion area;

Secondary

MeasureTime frame
OCT macular thickness;

Countries

China

Contacts

Public ContactTao Yong

Beijing Chaoyang Hospital, Capital Medical University

drtaoyong@sina.com+86 139 1030 8908

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026