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Trial record 35 of 36 for:    "Retinitis" | "Ganciclovir triphosphate"

Ganciclovir Implant Study for Cytomegalovirus Retinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000118
Recruitment Status : Completed
First Posted : September 24, 1999
Last Update Posted : September 17, 2009
Sponsor:
Information provided by:
National Eye Institute (NEI)

Tracking Information
First Submitted Date  ICMJE September 23, 1999
First Posted Date  ICMJE September 24, 1999
Last Update Posted Date September 17, 2009
Study Start Date  ICMJE October 1992
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00000118 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ganciclovir Implant Study for Cytomegalovirus Retinitis
Official Title  ICMJE Not Provided
Brief Summary 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).
Detailed Description

CMV retinitis occurs in 20 to 30 percent of patients with AIDS and is the leading cause of visual loss in these patients. At present, ganciclovir and foscarnet are the only drugs that have been approved by the U.S. Food and Drug Administration for the treatment of CMV retinitis. The therapeutic regimen for each drug consists of a 2-week induction period followed by daily maintenance intravenous infusions. Unfortunately, CMV retinitis usually progresses despite daily maintenance therapy, and both drugs are associated with significant systemic toxicity that often limits their therapeutic usefulness. As an alternative to intravenous administration, direct intravitreal injections of ganciclovir have been studied and have been shown to be effective in delaying the progression of CMV retinitis. The short half-life of the drug, however, necessitates one to two intraocular injections a week to maintain therapeutic levels. Widespread adoption of this technique has been limited because of the logistical difficulties and inherent risks associated with numerous intravitreal injections.

A drug delivery system capable of continuous delivery of ganciclovir into the vitreous cavity has been developed. The device consists of a 6-mg pellet of ganciclovir that is coated with a series of polymers with variable permeability to ganciclovir. The device is surgically implanted through the pars plana.

Thirty eyes of 26 patients with unilateral non-sight-threatening CMV retinitis were randomly assigned to one of two groups: (1) immediate therapy with a device designed to release ganciclovir into the vitreous cavity a over approximately a 4-month period or (2) deferred treatment. In patients with bilateral non-sight-threatening CMV retinitis, one eye was randomly assigned to receive a ganciclovir implant with the other eye assigned to deferred treatment. (Note: The original trial design included a third randomized arm using a 2 ug/hour device. This arm was dropped for logistical reasons after enrolling two patients.)

Patients assigned to immediate treatment underwent surgery to implant the ganciclovir device within 48 hours of enrollment and baseline photographs. Postoperatively, patients were evaluated the next day, weekly for 2 weeks, and then every 2 weeks until progression of CMV retinitis occurred. At each examination, in both eyes, visual acuity with current correction and best correction was determined using Early Treatment Diabetic Retinopathy Study eye charts; intraocular pressure was determined; evidence of inflammation or cataract was evaluated; and all retinal findings were documented. Any adverse event considered even possibly related to the device or to the implantation procedure was documented. Standardized nine-field fundus photographs were taken at each 2-week visit. The ganciclovir implant was exchanged at 32 weeks or earlier if progression of CMV retinitis occurred.

The primary end point was time to CMV retinitis progression, defined as the time (days) from initiating therapy until the advancement of 750-um over a 750 um front of any border of any lesion was observed. Standardized nine-field photographs were taken at 2-week intervals and analyzed in a masked fashion by the Fundus Photograph Reading Center to determine evidence of CMV retinitis progression.

Secondary end points included time to development of CMV retinitis in the contralateral eye, time to development of visceral CMV, and time to death.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Cytomegalovirus Retinitis
Intervention  ICMJE Device: Sustained-Release Intraocular Drug Delivery System
Study Arms  ICMJE Not Provided
Publications * Martin DF, Parks DJ, Mellow SD, Ferris FL, Walton RC, Remaley NA, Chew EY, Ashton P, Davis MD, Nussenblatt RB. Treatment of cytomegalovirus retinitis with an intraocular sustained-release ganciclovir implant. A randomized controlled clinical trial. Arch Ophthalmol. 1994 Dec;112(12):1531-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 1993
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000118
Other Study ID Numbers  ICMJE NEI-14
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Eye Institute (NEI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Eye Institute (NEI)
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP