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Anti-viral
Ganciclovir implant and oral ganciclovir for Cytomegalovirus Retinitis (GCCRT Trial)
Phase 3
Waitlist Available
Research Sponsored by Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
To compare the newest CMV retinitis drug, cidofovir, with a regimen of the ganciclovir intraocular device plus oral ganciclovir with respect to efficacy in preventing vision loss. To compare a treatment regimen that incorporates highly active local therapy (ganciclovir device) with a treatment regimen that does not.
Eligible Conditions
- Cytomegalovirus Retinitis
- Human Immunodeficiency Virus Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Group I: Ganciclovir implant and oral ganciclovirExperimental Treatment1 Intervention
Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily
Group II: Cidofovir IV (Intravenous)Experimental Treatment1 Intervention
cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ganciclovir implant and oral ganciclovir
1997
Completed Phase 3
~70
Cidofovir
FDA approved
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Who is running the clinical trial?
Johns Hopkins Bloomberg School of Public HealthLead Sponsor
423 Previous Clinical Trials
2,123,455 Total Patients Enrolled
5 Trials studying Cytomegalovirus Retinitis
3,178 Patients Enrolled for Cytomegalovirus Retinitis
Douglas Jabs, MDStudy ChairSOCA Chairman's Office
1 Previous Clinical Trials
64 Total Patients Enrolled
1 Trials studying Cytomegalovirus Retinitis
64 Patients Enrolled for Cytomegalovirus Retinitis
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