Early Manifest Glaucoma Trial (EMGT)



Sponsors


Source

National Eye Institute (NEI)

Brief Summary

The primary purpose is to compare the effect of immediate therapy to lower the intraocular
pressure (IOP) versus late or no treatment on the progression of newly detected open-angle
glaucoma, as measured by increasing visual field loss and/or optic disc changes.

The secondary purposes are to determine the extent of IOP reduction attained by treatment, to
explore factors that may influence glaucoma progression, and to describe the natural history
of newly detected glaucoma.

Detailed Description

Glaucoma is a common disease in older adults. All present treatment aims at reduction of the
intraocular pressure, but indications for therapy are not well defined. Furthermore, it is
unclear whether intraocular pressure influences the natural history of glaucoma. Against this
background, the primary aim of the study is of central importance to patients with manifest
and suspect glaucoma.

Glaucoma has few subjective symptoms during a long period early in the disease, but damage is
irreversible once it occurs. Early diagnosis and rapid detection of progression are of
paramount importance in limiting this damage, whether through pressure reduction or in some
other way. The effectiveness, if any, of lowering the intraocular pressure in glaucoma
requires evaluation by controlled treatment trials.

The Early Manifest Glaucoma Trial (EMGT) is the first large, controlled, randomized clinical
trial to evaluate the effect of lowering the intraocular pressure on the progression of newly
detected, open-angle glaucoma. This study will compare glaucoma progression in initially
treated versus untreated patients with newly detected open-angle glaucoma and will allow
quantification of the effect of immediate IOP-lowering treatment on progression during the
followup period.

The EMGT is a collaborative effort that involves a Clinical Center at the Department of
Ophthalmology of Malmo University Hospital at the University of Lund, Sweden, and its
Satellite Center in Helsingborg, Sweden; an independent Data Center at the Department of
Preventive Medicine, University Medical Center at Stony Brook, New York; and a Disc
Photography Reading Center at the Department of Ophthalmology in Lund at the University of
Lund. The study was initiated with support from the Swedish Medical Research Council.

Recruitment for the study has been completed. The 255 patients were identified by an
extensive, population-based screening of successive age cohorts as well as by clinical
referral. The diagnosis was confirmed through Humphrey perimetry at two postscreening visits
to the Clinical Center or Satellite Center. Eligible patients who agreed to participate had
two additional visits for collection of baseline data. They were randomized to treatment with
the beta blocker Betaxolol and argon laser trabeculoplasty (treated group) or to no initial
treatment (control group) with close followup of both groups.

Patients are followed for a minimum of 4 years to assess the development of glaucoma
progression. They are seen every 3 months to collect visual field, IOP, and other data. Disc
photographs are taken every 6 months. Technicians and disc photograph graders are masked
regarding treatment assignment. Additional followup visits are held to confirm visual field
progression and IOP elevation (>25 mm Hg in treated group, >35 mm Hg in control group).
Patients in the treated group receive Xalantan whenever IOP exceeds 25 mm Hg at more than one
visit; patients in the control group will receive Xalantan whenever IOP reaches 35 mm Hg or
higher during the trial. If IOP remains high, individualized treatment is given. All patients
continue to be followed to monitor the development of end points and will be analyzed in
their originally assigned groups.

The study outcome is glaucoma progression, which is based on specific criteria derived from
analyses of Humphrey visual fields and masked evaluations of disc photographs. The perimetric
outcome is defined as statistically significant deterioration (p < 0.05) of the same three or
more test points in Pattern Deviation Change Probability Maps in three consecutive C30-2
Humphrey fields. Optic disc progression is determined by the following:

- The presence of definite change (detected by comparison of followup photographs with
baseline) by flicker chronoscopy in two followup photographs from the same visit, with
independent confirmation by side-by-side gradings.

- Final confirmation of change toward progression, by flicker chronoscopy and by
side-by-side gradings, at a different followup visit.

Overall Status

Unknown status

Start Date

1992-10-01

Completion Date

N/A

Primary Completion Date

N/A

Phase

Phase 3

Study Type

Interventional


Condition


Intervention

Intervention Type

Drug

Intervention Name



Intervention Type

Procedure

Intervention Name




Eligibility

Criteria

Men and women between ages 50 and 80 years who have newly detected and untreated chronic
open-angle glaucoma with repeatable visual field defects by Humphrey perimetry are eligible
for inclusion.

Exclusion criteria include the following: advanced visual field loss (MD less than or equal
to 16 dB) or threat to fixation; mean IOP > 30 mm Hg or any IOP > 35 mm Hg in at least one
eye; VA < 0.5 in either eye; or any conditions precluding reliable fields or photos, use of
study treatment, or 4-year followup.

Gender

All

Minimum Age

50 Years

Maximum Age

80 Years


Location

Facility

Department of Ophthalmology, Helsingborg Hospital
Helsingborg Sweden
Department of Ophthalmology, Malmo University Hospital, University of Lund
Malmo Sweden

Location Countries

Country

Sweden


Verification Date

2001-10-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Has Expanded Access

No

Condition Browse


Intervention Browse

Mesh Term

Betaxolol


Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Primary Purpose

Treatment


Study First Submitted

September 23, 1999

Study First Submitted Qc

September 23, 1999

Study First Posted

September 24, 1999

Last Update Submitted

June 23, 2005

Last Update Submitted Qc

June 23, 2005

Last Update Posted

June 24, 2005

Last Known Status

Active, not recruiting


ClinicalTrials.gov processed this data on August 22, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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