GlaucomaPhase 3NCT00000148
Advanced Glaucoma Intervention Study (AGIS)
A Phase 3 study testing Argon Laser Trabeculoplasty and Trabeculectomy in people with Glaucoma, run by National Eye Institute (NEI) at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Argon Laser Trabeculoplasty and Trabeculectomy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 13 sitesUnited States
- Study dates
- Apr 1988to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Michigan, W.K. Kellogg Eye Center
Ann Arbor, Michigan
Emory University, Emory Eye Center
Atlanta, Georgia
Piedmont Hospital, Eye Consultants of Atlanta
Atlanta, Georgia
University of Virginia Medical Center, Department of Ophthalmology
Charlottesville, Virginia
Washington Hospital Center, Washington Eye Physicians and Surgeons
Chevy Chase, Maryland
Humana Health Plan Sykes Center
Chicago, Illinois
University of Illinois, Eye and Ear Infirmary
Chicago, Illinois
Ohio State University, Department of Ophthalmology, Ophthalmic Surgeons and Consultants
Columbus, Ohio
Yale University School of Medicine, Yale Eye Center
New Haven, Connecticut
Wills Eye Hospital, Glaucoma Service
Philadelphia, Pennsylvania
Medical College of Virginia, Department of Ophthalmology
Richmond, Virginia
Sinai Hospital, Detroit, Franklin Eye Consultants
Southfield, Michigan
Georgetown University, University Ophthalmic Consultants of Washington, Eye Associates of Washington, D.C.
Washington D.C., District of Columbia
About this study
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Argon Laser Trabeculoplasty, Trabeculectomy
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argon Laser TrabeculoplastyProcedure or surgery
TrabeculectomyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 1999 (estimated)
- Study startApr 1988
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000148
- Sponsor's protocol ID
- NEI-49
- Status last verified
- Oct 2003
- First submitted
- 23 Sep 1999
- Last updated
- 5 Jun 2006
- Results posted
- No
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.
PubMed 7956270Advanced Glaucoma Intervention Study. 2. Visual field test scoring and reliability. Ophthalmology. 1994 Aug;101(8):1445-55.
PubMed 7741836The 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.
PubMed 9663214The 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.
PubMed 9663215Caprioli 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.
PubMed 21467178
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Glaucoma Intervention Study (AGIS)
- ClinicalTrials.gov ID
- NCT00000148
- Acronym / sponsor ID
- NEI-49
- Conditions
- Glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Apr 1988
- First posted
- 24 Sep 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Argon Laser Trabeculoplasty | Procedure or surgery | – |
| Trabeculectomy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2006.
- BackgroundThe Advanced Glaucoma Intervention Study (AGIS) Manual of Operations. Springfield, Virginia., National Technical Information Service, 1993;No. PB93-220192
- Background: PubMed 7956270Ederer 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.
- Background: PubMed 7741836Advanced Glaucoma Intervention Study. 2. Visual field test scoring and reliability. Ophthalmology. 1994 Aug;101(8):1445-55.
- BackgroundThe Advanced Glaucoma Intervention Study (AGIS) Data Management Handbook. Springfield, Virginia., National Technical Information Service, Document, 1996;No. PB96-137120
- Background: PubMed 9663214The 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.
- Background: PubMed 9663215The 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.
- Derived from this study: PubMed 21467178Caprioli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Argon Laser Trabeculoplasty and Trabeculectomy in people with Glaucoma, run by National Eye Institute (NEI) at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000148, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2006.