Completed

Ganciclovir Implant and Oral Ganciclovir for Cytomegalovirus Retinitis

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What is being tested

Ganciclovir

Drug
Who is being recruted

Blood-Borne Infections+30

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+30 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorRoche Global Development
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant alone, or IV ganciclovir.

NCT00002134
Principal SponsorRoche Global Development
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

450 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAmino Acid Metabolism, Inborn ErrorsCommunicable DiseasesCytomegalovirus InfectionsDNA Virus InfectionsEye DiseasesHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesRetinal DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralEye InfectionsEye Infections, ViralLentivirus InfectionsMitochondrial DiseasesGenetic Diseases, InbornAcquired Immunodeficiency SyndromeRetinitisHIV InfectionsCytomegalovirus RetinitisMultiple Acyl Coenzyme A Dehydrogenase Deficiency

Criteria

3 inclusion criteria required to participate
AIDS
Unilateral CMV retinitis
Topical drugs and ophthalmics
27 exclusion criteria prevent from participating
Acute retinal necrosis or any other intraocular condition that might preclude study completion
Any prior oral ganciclovir in a CMV retinitis treatment protocol OR more than 4 months of prior oral ganciclovir in a prophylaxis study (per amendment)
Chronic, clinically significant diarrhea, nausea, abdominal pain,or other symptoms of uncontrolled gastrointestinal disease
History of hypersensitivity to acyclovir or ganciclovir
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 23 locations

Dr Neil Brourman

Beverly Hills, United StatesOpen Dr Neil Brourman in Google Maps

UCI College of Medicine

Irvine, United States

Estelle Doheny Eye Clinic

Los Angeles, United States

Dr Robert T Wendel

Sacramento, United States
Completed23 Study Centers