Zoster Eye Disease Study

Description

This is a multi-center, randomized, double-masked, placebo-controlled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to Herpes Zoster Ophthalmicus (HZO) in the year prior to enrollment.

Study Start Date

August, 23 2017

Estimated Completion Date

December 2020

Interventions

  • Drug: Masked Placebo
  • Drug: Masked Oral Valacyclovir

Study ID

New York University School of Medicine -- 16-00463

Status

Recruiting

Trial ID

NCT03134196

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

1050

Sponsor

New York University School of Medicine

PARTICIPANT INCLUSION CRITERIA To be eligible for study participation, an individual must meet all of the following criteria: 1. Ability to understand, and willingness and ability to read and sign, the informed consent form. 2. Ability to understand and follow instructions and study procedures. 3. Willingness to comply with all study procedures and be available for the duration of the study. 4. Ability to take oral medication, and are willing to adhere to study medication regimen. 5. Age 18 years or older. 6. Diagnosed with HZO in one eye based on both of these criteria: 1. History of characteristic unilateral vesicular rash in the dermatomal distribution of cranial nerve V1. 2. Medical record documentation of an episode of active dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to HZO within the preceding year. This episode of active anterior segment ocular disease may be due to HZO of recent onset (within the preceding 6 months) or chronic HZO (with onset six or more months ago) may be new, worsening, or recurrent disease after a period of inactivity and may occur after medication was reduced. i. Study participants with chronic HZO must be on a stable treatment regimen and off antivirals for at least 30 days before enrollment. Study participants with chronic HZO who do not meet this criterion may be rescreened, if they are able to meet this criterion within 3 months after the study visit. (This is not a requirement for study participants with recent onset HZO, who may be enrolled at any time, preferably after completing recommended acute antiviral treatment, if prescribed, is completed). 7. For females with reproductive potential, willingness to use highly effective contraception (e.g., hormonal contraception, barrier contraception, intrauterine device, or abstinence). PARTICIPANT EXCLUSION CRITERIA An individual who meets any of the following criteria will be excluded from participation in this study: 1. History of immunocompromised status as defined by current CDC contraindications for the vaccine against zoster (44). 1. Study participants who are diagnosed with leukemia, lymphomas or other malignant neoplasms affecting bone marrow or lymphatic system, unless leukemia in remission and off chemotherapy for at least 3 months. 2. Study participants who are diagnosed with Acquired Immune Deficiency Syndrome (AIDS) or presents with other clinical manifestations of Human Immunodeficiency virus (HIV) including CD4 count of ? 200 cells/ml. 3. Study participants on immunosuppressive therapy including: i. High-dose corticosteroids (greater than equivalent of prednisone 20 mg/day within 1 month) ii. Chemotherapy, other than low dose used for treatment of immune-mediated diseases within 3 months iii. Study participants receiving recombinant human immune mediators and immune modulators, especially antitumor necrosis agents, within 1 month prior to enrollment d. Study participants with unspecified cellular immunodeficiency. e. Study participants with history of hematopoietic stem cell transplantation. 2. Medical history of a systemic disease and thought likely to meet one of the exclusion criteria listed in exclusion criterion #1 during the 18-month study period. 3. Renal insufficiency: 1. Requires dialysis or has history of renal transplant or 2. eGFR less than 45, determined within 30 days preceding enrollment. 4. Allergy or adverse reaction to valacyclovir or acyclovir. 5. History of vaccination against zoster within one month prior to enrollment. Study participants who meet this exclusion criterion may be rescreened. 6. Keratoplasty or keratorefractive surgery of the involved eye with zoster. 7. On systemic antivirals with activity against herpes within the past 30 days, including acyclovir, valacyclovir, or famciclovir, for any reason except for treatment of acute HZO, including investigational drug trial. 8. History of another condition that may require treatment with one of these three antivirals listed above in exclusion criterion #7, during the course of the study study participants who require chronic suppressive antiviral treatment with these medications will be excluded. 9. Sexually active women who are pregnant, nursing, or in their reproductive years who do not agree to use contraception during the 1-year treatment period. 10. Incarceration 11. Any condition or circumstance that in the opinion of the study investigator, would place the study participant in increased risk or affect his/her full compliance or completion of the study. 12. Participation in a clinical study testing a drug, biologic, device or other intervention within the last 30 days from enrollment visit. Study participants who meet this criterion may be rescreened.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (18)

Study Location Distance Name Phone Email
Massachusetts Eye and Ear Infirmary - Boston, Massachusetts 2.8 miles Vijeeta Tadla 617-573-6823 Vijeeta_Tadla@meei.harvard.edu
NYU Langone Health - New York, New York 186.5 miles Stacy Mach 646-501-9883 Stacy.Mach@nyumc.org
EyeCare MD of NJ - Morristown, New Jersey 206.4 miles Heather Ademovic 973-984-3937 frontdesk@eyecaremdnj.com
Corneal Associates at Wills Eye Hospital - Philadelphia, Pennsylvania 269.5 miles Kimberly Reilly 215-928-3180 kreilly@willseye.org
Ophthalmic Partners of Pennsylvania PC - Bala-Cynwyd, Pennsylvania 269.7 miles Cathy Petrocella 484-434-2706 cpetrocella@oppdoctors.com
Ophthalmic Partners of Pennsylvania PC - Bala-Cynwyd, Pennsylvania 269.7 miles Cathy Petrocella 484-434-2706 cpetrocella@oppdoctors.com
Ophthalmic Partners of Pennsylvania PC - Bala-Cynwyd, Pennsylvania 269.7 miles Cathy Petrocella 484-434-2706 cpetrocella@oppdoctors.com
Ophthalmic Partners of Pennsylvania PC - Bala-Cynwyd, Pennsylvania 269.7 miles Cathy Petrocella 484-434-2706 cpetrocella@oppdoctors.com
Verdier Eye Center - Grand Rapids, Michigan 735.6 miles Paula Johnson 616-949-2001 PJohnson@vecgr.com
Cornea Consultants of Nashville - Nashville, Tennessee 942.8 miles Shannon Reid 615-320-7200 sreid@corneaconsultants.net
Vanderbilt Eye Institute - Nashville, Tennessee 944.2 miles Scott Ruark 615-936-1639 scott.ruark@vanderbilt.edu
Dean McGee Eye Institute - Oklahoma City, Oklahoma 1,493.6 miles Amy Ford 405-271-6307 amy-ford@dmei.org
Cornea Associates of Texas - Dallas, Texas 1,545.0 miles Jennifer Raines 214-696-5900 jraines@corneatexas.com
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles Christine Chan 206-342-6976 christine.chan@virginiamason.org
Pacific Eye Surgeons Inc - San Luis Obispo, California 2,680.9 miles Vaneza A Espino 805-503-1016 vespino@paceyemd.com
Pacific Eye Surgeons Inc - San Luis Obispo, California 2,680.9 miles Vaneza A Espino 805-503-1016 vespino@paceyemd.com
Pacific Eye Surgeons Inc - San Luis Obispo, California 2,680.9 miles Vaneza A Espino 805-503-1016 vespino@paceyemd.com
Pacific Eye Surgeons Inc - San Luis Obispo, California 2,680.9 miles Vaneza A Espino 805-503-1016 vespino@paceyemd.com

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