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NCT00000148 Clinical Trial

Advanced Glaucoma Intervention Study (AGIS)

Glaucoma Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00000148
Other study ID # NEI-49
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received September 23, 1999
Last updated June 2, 2006
Start date April 1988

Study information
Verified date October 2003
Source National Eye Institute (NEI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Argon Laser Trabeculoplasty

• Trabeculectomy

Locations
Country Name City State
United States University of Michigan, W.K. Kellogg Eye Center Ann Arbor Michigan
United States Emory University, Emory Eye Center Atlanta Georgia
United States Piedmont Hospital, Eye Consultants of Atlanta Atlanta Georgia
United States University of Virginia Medical Center, Department of Ophthalmology Charlottesville Virginia
United States Washington Hospital Center, Washington Eye Physicians and Surgeons Chevy Chase Maryland
United States Humana Health Plan Sykes Center Chicago Illinois
United States University of Illinois, Eye and Ear Infirmary Chicago Illinois
United States Ohio State University, Department of Ophthalmology, Ophthalmic Surgeons and Consultants Columbus Ohio
United States Yale University School of Medicine, Yale Eye Center New Haven Connecticut
United States Wills Eye Hospital, Glaucoma Service Philadelphia Pennsylvania
United States Medical College of Virginia, Department of Ophthalmology Richmond Virginia
United States Sinai Hospital, Detroit, Franklin Eye Consultants Southfield Michigan
United States Georgetown University, University Ophthalmic Consultants of Washington, Eye Associates of Washington, D.C. Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Advanced Glaucoma Intervention Study. 2. Visual field test scoring and reliability. Ophthalmology. 1994 Aug;101(8):1445-55. — View 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. — View Citation

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) Manual of Operations. Springfield, Virginia., National Technical Information Service, 1993;No. PB93-220192

The Advanced Glaucoma Intervention Study (AGIS): 3. Baseline characteristics of black and white patients. Ophthalmology. 1998 Jul;105(7):1137-45. — View Citation

The Advanced Glaucoma Intervention Study (AGIS): 4. Comparison of treatment outcomes within race. Seven-year results. Ophthalmology. 1998 Jul;105(7):1146-64. — View Citation

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