Herpetic Eye Disease Study (HEDS) II
Information source: National Eye Institute (NEI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Keratitis, Herpetic; Ocular Herpes Simplex; Herpes Simplex
Intervention: Stress (Behavioral); Acyclovir (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: National Eye Institute (NEI)
Summary
To determine whether early treatment (with oral acyclovir) of herpes simplex virus (HSV)
ulcerations of the corneal epithelium prevents progression to the blinding complications of
stromal keratitis and iridocyclitis.
To determine the efficacy of low-dose oral acyclovir in preventing recurrent HSV eye
infection in patients with previous episodes of herpetic eye disease.
To determine the role of external factors (such as ultraviolet light or corneal trauma) and
behavioral factors (such as life stress) on the induction of ocular recurrences of HSV eye
infections and disease.
Clinical Details
Study design: Treatment, Randomized, Placebo Control
Detailed description:
Infection of the eye by herpes simplex virus (HSV) is a leading cause of corneal blindness in
the United States and other countries. The infection can lead to corneal scarring and
neovascularization, permanent endothelial dysfunction and corneal edema, secondary glaucoma,
and cataract. Despite the availability of topical antiviral agents that are highly active
against HSV keratitis, there is still no known effective method for reducing the frequency of
recurrence or severity of stromal keratitis and iridocyclitis. In addition, the prognosis is
poor for recovery of good vision following penetrating keratoplasty for actively inflamed or
highly vascularized herpetic corneas.
On the basis of both animal and human studies, the antiviral agent acyclovir may both treat
and prevent recurrence of HSV disease. However, no consensus yet exists on the use of
acyclovir in the management and prevention of herpetic eye disease.
HEDS-II consists of two randomized, placebo-controlled trials that are assessing the role of
oral acyclovir in the management of herpetic eye disease and one epidemiologic study that is
investigating risk factors, including stress, for the development of ocular recurrences of
the disease. The organizational structure consists of a national coordinating center, eight
regional coordinating clinical centers, and approximately 60 clinical sites. The clinical
sites where patients are enrolled and followed include both university-based and
community-based practices.
Herpes Simplex Virus Epithelial Keratitis Trial: HEDS-EKT evaluated the benefit of oral
acyclovir given during treatment of an acute HSV keratitis (dendritic or geographic
keratitis) in preventing the occurrence of later blinding complications. Patients entered the
trial within 7 days of onset. All patients received standard treatment with a topical
antiviral and were randomized to receive either oral acyclovir (400 mg five times a day for
21 days) or a placebo. Patients had eight visits within a 12-month followup period. The
primary outcome was the time to the first occurrence of stromal keratitis or iridocyclitis
in the study eye (eye with epithelial keratitis at time of study entry). The HEDS-EKT
recruitment goal was 502 patients.
Acyclovir Prevention Trial: HEDS-APT evaluated the benefit of long-term acyclovir treatment
in patients with a recent history of HSV eye disease but no current active disease. To be
eligible, a patient must have experienced any kind of ocular herpes simplex infection
(blepharitis, conjunctivitis, keratitis, or iridocyclitis) in the preceding year. The
infection must have been inactive and untreated for at least the previous 30 days. Patients
were randomized to receive either oral acyclovir (400 mg twice a day) or placebo for 1 year.
Five followup visits occurred during the 1-year treatment period and an additional three
followup visits during the 6-month post-treatment period. Episodes of recurrent HSV eye
disease during the trial were treated with topical corticosteroids and antivirals as
indicated, but patients continued to receive the oral acyclovir or placebo for the entire
365-day period. The primary outcome was the time to the first recurrence of any type of HSV
eye disease in either eye. The recruitment goal was 696 patients.
Ocular HSV Recurrence Factor Study: HEDS-RFS is evaluating the effect of psychological,
environmental, and biological factors on recurrences of herpetic eye disease. Patients
recruited into the HEDS-APT trial are eligible to participate in HEDS-RFS if they are 18
years or older. At entry, all subjects fill out a questionnaire to estimate the negative
affectivity trait measure. Subjects also fill out a short questionnaire every week for 52
weeks to track acute and chronic stressors (e. g., illnesses, injuries, menstrual periods, sun
exposure, emotional and financial stresses). The investigators ensure patient privacy by the
patient's mailing of the weekly logs directly to the HEDS National Coordinating Center.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Protocol-specific criteria are noted in the description above.
Locations and Contacts
Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States
Emory Eye Center, Atlanta, Georgia, United States
Eye Center, University of Illinois, Chicago, Chicago, Illinois, United States
Louisiana State University Eye Center, New Orleans, Louisiana, United States
Department of Ophthalmology, The Mount Sinai Medical Center, New York, New York, United States
Wills Eye Hospital, Cornea Clinic, Philadelphia, Pennsylvania, United States
Cullen Eye Institute, Baylor College of Medicine, Houston, Texas, United States
The Eye Institute, Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Additional Information
NEI Press Release-Antiviral Drug Sharply Reduces Return of Herpes of the Eye Herpetic Eye Disease Study (HEDS) I
Related publications: Dawson CR, Beck R, Wilhelmus KR, Cohen EJ. Herpetic eye disease study. You can help. Arch Ophthalmol. 1996 Jan;114(1):89-90. Review. No abstract available. [No authors listed] A controlled trial of oral acyclovir for the prevention of stromal keratitis or iritis in patients with herpes simplex virus epithelial keratitis. The Epithelial Keratitis Trial. The Herpetic Eye Disease Study Group. Arch Ophthalmol. 1997 Jun;115(6):703-12. [No authors listed] Acyclovir for the prevention of recurrent herpes simplex virus eye disease. Herpetic Eye Disease Study Group. N Engl J Med. 1998 Jul 30;339(5):300-6.
Starting date: October 1992
Last updated: June 1, 2006
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