Completed

Phase 3
All Genders
ID00000118

Led by National Eye Institute (NEI) · Updated on 2009-09-17

N/A

Participants Needed

N/A

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

To determine the therapeutic efficacy of a sustained-release intraocular drug delivery system for ganciclovir therapy of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).

CONDITIONS

Official Title

Ganciclovir Implant Study for Cytomegalovirus Retinitis

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

All patients must have had AIDS as defined by the Centers for Disease Control and Prevention and non-sight-threatening CMV retinitis Patients could not have been previously treated with systemic ganciclovir or foscarnet and must not have had evidence of other organ involvement with CMV. Patients must have had an absolute neutrophil count (ANC) greater than 1,000 cells/mL and a platelet count greater than 25,000/mm3

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Site Locations not provided

Location information for this trial is currently unavailable.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

RANDOMIZED

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

Treatment of cytomegalovirus retinitis with an intraocular sustained-release ganciclovir implant. A randomized controlled clinical trial.

D F Martin, D J Parks, S D Mellow...

https://pubmed.ncbi.nlm.nih.gov/7993207