HIV Infections Clinical Trial
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
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