|
Herpetic Eye Disease Study (HEDS) II Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Herpetic Eye Disease Study (HEDS) II conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Herpetic Eye Disease Study (HEDS) II Clinical research trials and Herpetic Eye Disease Study (HEDS) II medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Herpetic Eye Disease Study (HEDS) II. Herpetic Eye Disease Study (HEDS) II Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Herpetic Eye Disease Study (HEDS) II clinical trial. Participants frequently get the best healthcare available for their Herpetic Eye Disease Study (HEDS) II condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "H" Clinical Trials Conditions > Herpetic Eye Disease Study (HEDS) II  Herpetic Eye Disease Study (HEDS) II
Herpetic Eye Disease Study (HEDS) II
For Condition: Keratitis, Herpetic,Ocular Herpes Simplex,Herpes Simplex
Status: No longer recruiting
Sponsor(s): National Eye Institute (NEI) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Placebo Control
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Protocol-specific criteria are noted in the description above.
Total Enrollment:
Location and Contact Information:
Cullen Eye Institute, Baylor College of Medicine
Houston, Texas,
United States
Francis I. Proctor Foundation, University of California, San Francisco
San Francisco, California,
United States
Eye Center, University of Illinois, Chicago
Chicago, Illinois,
United States
The Eye Institute, Medical College of Wisconsin
Milwaukee, Wisconsin,
United States
Department of Ophthalmology, The Mount Sinai Medical Center
New York City, New York,
United States
Emory Eye Center
Atlanta, Georgia,
United States
Wills Eye Hospital, Cornea Clinic
Philadelphia, Pennsylvania,
United States
Louisiana State University Eye Center
New Orleans, Louisiana,
United States
Additional Information:
Study ID Numbers: NEI-38;
Study Start Date: October 1992
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000139
Other Herpes Simplex Studies:
1. Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients with AIDS Who Have Not Had Success with Acyclovir
2. Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
3. A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
4. A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients
5. Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel with Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects with Acquired Immunodeficiency Syndrome (AIDS)
Related Studies:
Other Herpes Simplex Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Herpetic Eye Disease Study (HEDS) II
|
|
|
|
|
|
|
|
