Clinical trial NCT00000148: Advanced Glaucoma Intervention Study (AGIS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Glaucoma
Lead sponsor: National Eye Institute (NEI)
Sponsor class: NIH
First posted: 1999-09-24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: To assess the long-range outcomes of sequences of interventions involving trabeculectomy and argon laser trabeculoplasty in eyes that have failed initial medical treatment for glaucoma.

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.

Eligibility criteria: Men and women between the ages of 35 and 80 with open-angle glaucoma that was not successfully controlled by medication were eligible for enrollment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine, Yale Eye Center
state: Connecticut
city: Washington
country: United States
facility: Georgetown University, University Ophthalmic Consultants of Washington, Eye Associates of Washington, D.C.
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University, Emory Eye Center
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hospital, Eye Consultants of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Humana Health Plan Sykes Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois, Eye and Ear Infirmary
state: Illinois
city: Chevy Chase
country: United States
facility: Washington Hospital Center, Washington Eye Physicians and Surgeons
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan, W.K. Kellogg Eye Center
state: Michigan
city: Southfield
country: United States
facility: Sinai Hospital, Detroit, Franklin Eye Consultants
state: Michigan
city: Columbus
country: United States
facility: Ohio State University, Department of Ophthalmology, Ophthalmic Surgeons and Consultants
state: Ohio
city: Philadelphia
country: United States
facility: Wills Eye Hospital, Glaucoma Service
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia Medical Center, Department of Ophthalmology
state: Virginia
city: Richmond
country: United States
facility: Medical College of Virginia, Department of Ophthalmology
state: Virginia
Study officials:
References:
citation: The Advanced Glaucoma Intervention Study (AGIS) Manual of Operations. Springfield, Virginia., National Technical Information Service, 1993;No. PB93-220192
citation: 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.
citation: Advanced Glaucoma Intervention Study. 2. Visual field test scoring and reliability. Ophthalmology. 1994 Aug;101(8):1445-55.
citation: The Advanced Glaucoma Intervention Study (AGIS) Data Management Handbook. Springfield, Virginia., National Technical Information Service, Document, 1996;No. PB96-137120
citation: 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.
citation: 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.
citation: 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.