- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000148
Advanced Glaucoma Intervention Study (AGIS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In advanced glaucoma, medication alone no longer reduces intraocular pressure adequately, and the eye has field defects. Before 1980, some type of filtering surgery, such as trabeculectomy, was the usual method of intervention. Since then, laser trabeculoplasty has become a popular alternative. Sometimes the first intervention chosen succeeds in controlling pressure for many years; at other times, the success lasts only a few weeks or months. Because success is limited, some patients, over time, need to undergo a sequence of surgical interventions. Little is known about which sequence gives the best long-range outcome.
The Advanced Glaucoma Intervention Study (AGIS) is designed to provide a comprehensive assessment of the long-range outcomes of medical and surgical management in advanced glaucoma. The study uses visual function status to compare two intervention sequences in managing the disease.
Eligible eyes are randomly assigned to one of two intervention sequences: (1) trabeculectomy, followed by argon laser trabeculoplasty (ALT) should trabeculectomy fail, followed by a second trabeculectomy should ALT fail; or (2) ALT, followed by trabeculectomy should ALT fail, followed by another trabeculectomy should the first trabeculectomy fail. Antifibrotic agents may be used as an adjunct to trabeculectomy, but only in eyes with a previous history of invasive surgery. Eyes that fail the entire assigned sequence of interventions are managed at the discretion of the AGIS physician in collaboration with the patient.
Interventions are supplemented with medical treatment as needed. A total of 789 eyes with advanced glaucoma have been enrolled. All patients are being followed under a standardized protocol for a minimum of 5 years to determine degree of visual function loss, failure rates of interventions, rates of complications, and need for supplemental therapy.
After the initial intervention, followup examinations are scheduled at 1 week, 4 weeks, 3 months, 6 months, and every 6 months thereafter. After second and third interventions, followup examinations are scheduled at 1 and 4 weeks. Additional visits are scheduled as necessary for the management of the disease.
The primary outcome variable in AGIS is average percent of eyes with decrease of vision, where decrease of vision is a substantial decline of either visual field or visual acuity attributable to the effect of glaucoma. Secondary outcome variables include sustained decrease of vision, failure of interventions, number of prescribed glaucoma medications, and level of intraocular pressure. An ancillary study is assessing filtering bleb encapsulation.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States
- Yale University School of Medicine, Yale Eye Center
-
-
District of Columbia
-
Washington, District of Columbia, United States
- Georgetown University, University Ophthalmic Consultants of Washington, Eye Associates of Washington, D.C.
-
-
Georgia
-
Atlanta, Georgia, United States
- Emory University, Emory Eye Center
-
Atlanta, Georgia, United States
- Piedmont Hospital, Eye Consultants of Atlanta
-
-
Illinois
-
Chicago, Illinois, United States
- Humana Health Plan Sykes Center
-
Chicago, Illinois, United States
- University of Illinois, Eye and Ear Infirmary
-
-
Maryland
-
Chevy Chase, Maryland, United States
- Washington Hospital Center, Washington Eye Physicians and Surgeons
-
-
Michigan
-
Ann Arbor, Michigan, United States
- University of Michigan, W.K. Kellogg Eye Center
-
Southfield, Michigan, United States
- Sinai Hospital, Detroit, Franklin Eye Consultants
-
-
Ohio
-
Columbus, Ohio, United States
- Ohio State University, Department of Ophthalmology, Ophthalmic Surgeons and Consultants
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States
- Wills Eye Hospital, Glaucoma Service
-
-
Virginia
-
Charlottesville, Virginia, United States
- University of Virginia Medical Center, Department of Ophthalmology
-
Richmond, Virginia, United States
- Medical College of Virginia, Department of Ophthalmology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- The Advanced Glaucoma Intervention Study (AGIS) Manual of Operations. Springfield, Virginia., National Technical Information Service, 1993;No. PB93-220192
- Ederer F, Gaasterland DE, Sullivan EK; AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS): 1. Study design and methods and baseline characteristics of study patients. Control Clin Trials. 1994 Aug;15(4):299-325. doi: 10.1016/0197-2456(94)90046-9.
- Advanced Glaucoma Intervention Study. 2. Visual field test scoring and reliability. Ophthalmology. 1994 Aug;101(8):1445-55.
- The Advanced Glaucoma Intervention Study (AGIS) Data Management Handbook. Springfield, Virginia., National Technical Information Service, Document, 1996;No. PB96-137120
- The Advanced Glaucoma Intervention Study (AGIS): 3. Baseline characteristics of black and white patients. Ophthalmology. 1998 Jul;105(7):1137-45. doi: 10.1016/s0161-6420(98)97012-9.
- The Advanced Glaucoma Intervention Study (AGIS): 4. Comparison of treatment outcomes within race. Seven-year results. Ophthalmology. 1998 Jul;105(7):1146-64. doi: 10.1016/s0161-6420(98)97013-0.
- Caprioli J, Mock D, Bitrian E, Afifi AA, Yu F, Nouri-Mahdavi K, Coleman AL. A method to measure and predict rates of regional visual field decay in glaucoma. Invest Ophthalmol Vis Sci. 2011 Jul 1;52(7):4765-73. doi: 10.1167/iovs.10-6414.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEI-49
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glaucoma
-
Imperial College Healthcare NHS TrustIRIDEX CorporationNot yet recruitingGlaucoma | Glaucoma, Open-Angle | Glaucoma, Angle-Closure | Glaucoma, Neovascular | Glaucoma Eye | Glaucoma Secondary | Glaucoma Traumatic | Glaucoma Uveitic
-
Wills EyeIOP OphthalmicsTerminatedPrimary Open Angle Glaucoma | Neovascular Glaucoma | Uveitic Glaucoma | Pseudoexfoliation Glaucoma | Primary Angle Closure Glaucoma | Pigmentary Glaucoma | Traumatic GlaucomaUnited States
-
Centre hospitalier de l'Université de Montréal...CompletedGlaucoma | Glaucoma, Open-Angle | Glaucoma, Neovascular | Glaucoma Eye | Glaucoma and Ocular Hypertension | Glaucoma, Uncompensated | Glaucoma SecondaryCanada
-
Pro Top & Mediking Company LimitedCompletedOpen Angle Glaucoma | Neovascular Glaucoma | Angle Closure Glaucoma | Uveitis Glaucoma | Young Age Glaucoma | High Risk PatientEstonia
-
Sanoculis LtdCompletedPrimary Open Angle Glaucoma | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaIsrael
-
Bausch & Lomb IncorporatedNicOx Inc.CompletedPrimary Open Angle Glaucoma | Ocular Hypertension | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaUnited States
-
Sensimed AGCompletedPrimary Open Angle Glaucoma | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaFrance
-
Wills EyeOptovueCompletedPrimary Open-angle Glaucoma | Normal Tension Glaucoma | Glaucoma; DrugsUnited States
-
iSTAR MedicalInternational Drug Development InstituteActive, not recruitingGlaucoma, Open-Angle Glaucoma EyeIndia, Panama
-
Dr. Kaweh MansouriEnrolling by invitationGlaucoma, Angle-Closure | Surgery | Glaucoma, Neovascular | Glaucoma Eye | Glaucoma; Drugs | Glaucoma, Pigmentary | Glaucoma Secondary | Glaucoma Open-Angle | Glaucoma Congenital | Glaucoma CapsulareSwitzerland
Clinical Trials on Trabeculectomy
-
Sunnybrook Health Sciences CentreCompletedGlaucoma | Corneal Endothelial Cell LossCanada
-
Shanghai Eye Disease Prevention and Treatment CenterUnknown
-
University of OklahomaCompletedPrimary Open Angle Glaucoma | Cataract | Pigmentary GlaucomaUnited States
-
University of ZurichCompleted
-
Assiut UniversityUnknownGlaucoma | Angle Closure Glaucoma | Cataract SecondaryEgypt
-
Queen's UniversityGlaucoma Research & Education GroupWithdrawn
-
Sun Yat-sen UniversityGuangdong Province, Department of Science and Technology; Ministry of Science...CompletedGlaucoma, Angle-Closure | Cataract
-
University of ParmaCompleted