Cytomegalovirus Infections Clinical Trial
Official title:
Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes
Recurrent anterior uveitis in immunocompetent individuals can be caused by multiple members
of the herpes virus group, including cytomegalovirus (CMV). Repeated bouts of CMV intraocular
inflammation can be associated with ocular hypertension, glaucoma, pain, vision reduction or
blindness. CMV anterior uveitis is commonly misdiagnosed as a non-infectious anterior uveitis
and treated as such, which can beget further complications. Diagnosis requires directed
polymerase chain reaction (PCR) testing. While antiviral therapy exists for CMV, identifying
the appropriate therapy has been challenging because no randomized trials comparing routes of
therapy (particularly oral or topical) have been performed. Currently, CMV anterior uveitis
is typically treated with oral valganciclovir in the United States but carries the risk of
serious systemic side effects that necessitate laboratory monitoring. There is evidence that
suggests topical ganciclovir can be used to treat and prevent recurrences of CMV anterior
uveitis, though the appropriate concentration is not well defined. Topical ganciclovir is
attractive because it does not require laboratory monitoring, though a unique side effect
profile that includes corneal epitheliopathy and conjunctivitis may preclude long-term use.
While anterior chamber paracentesis with polymerase chain reaction (PCR) testing demonstrates
CMV during an initial flare of inflammation, it is unknown whether repeated recurrences of
inflammation are mediated by viral re-infection and replication in the anterior chamber or if
a sterile immune response is at play. Consequently, patients may be submitted to many years
of oral or topical antiviral therapy. This strategy poses challenges without proper
evaluation of the multiple treatment and long-term management approaches. Further studies are
needed to elucidate the most appropriate antiviral therapies that balance efficacy and
toxicity while treating CMV anterior uveitis.
We hypothesize that the efficacy of oral valganciclovir in the treatment of cytomegalovirus
(CMV) anterior uveitis will be greater when compared to topical or placebo treatments.
This study will be a multicenter, double-masked, randomized, placebo-controlled clinical
trial.
Specific Aims of the Project:
1a. To assess reduction in CMV viral load at 7 days after randomization to treatment with
oral or topical antiviral. We hypothesize that the greatest reduction in viral load will be
with oral valganciclovir 900 mg PO BID compared to topical ganciclovir 2% every 2 hours daily
and placebo.
1b. To assess intraocular drug concentration at 7 days after randomization to treatment with
oral or topical antiviral. We hypothesize that the greatest concentration of drug within the
anterior chamber fluid will be found with oral valganciclovir 900 mg PO BID compared to
topical ganciclovir and placebo.
1c. To assess the percentage of patients with clinical quiescence after randomization to 28
days of treatment. We hypothesize that the proportion of patients that have achieved clinical
quiescence at 28 days will be higher with oral valganciclovir compared to topical ganciclovir
and placebo.
1d. To evaluate the effect of topical corticosteroid started prior to eligibility screening
on diagnostic yield of PCR. We hypothesize that the yield of virus will be positively
correlated with increased frequency of use of topical corticosteroids.
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