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Choroidal NeovascularizationPhase 3NCT00000158

Macular Photocoagulation Study (MPS)

A Phase 3 study testing Argon Blue-Green Laser Photocoagulation in people with Choroidal Neovascularization and Macular Degeneration, run by National Eye Institute (NEI).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate laser treatment of choroidal neovascularization (CNV) through randomized, controlled clinical trials. The Macular Photocoagulation Study (MPS) consisted of three sets of randomized, controlled clinical trials. Change in best-corrected visual acuity from baseline was the primary outcome for all MPS trials. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Argon Blue-Green Laser Photocoagulation
Type of treatment
Surgery or procedure
How many people
Not given
Where
No sites listed yet
Study dates
Feb 1979to 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Common Eligibility Criteria for the Argon, Krypton, and Foveal Studies:

To be eligible, men and women must have been experiencing visual symptoms attributable to the macular lesion, such as decreased visual acuity or Amsler grid distortion, at the time of entry into the study. They also must have had visible, well-demarcated hyperfluorescence characteristic of classic choroidal neovascularization on fluorescein angiography. AMD patients were 50 years of age or older and had drusen visible in the macula of at least one eye. POH patients were at least 18 years old and had at least one characteristic histo spot in one or both eyes. INVM patients were at least 18 years old and had no evidence of AMD, POH, angioid streaks, high myopia, diabetic retinopathy, or any other condition that could be the cause of the neovascularization. In particular, INVM patients had neither drusen greater than MPS Standard Photograph No. 1.1 nor histo spots in either eye.

Additional Patient Eligibility Criteria for the Argon Study:

Each patient had a visible serous detachment of the sensory retina with a diffuse area of leakage, discrete choroidal neovascularization outside the fovea (200-2,500 microns from the center of the FAZ), and visual acuity of 20/100 or better in the study eye.

Additional Patient Eligibility Criteria for the Krypton Study:

All patients had a neovascular lesion consisting of neovascularization and possibly blood and/or pigment that extended into the FAZ. The posterior border of CNV could extend as close as 1 micron to the FAZ center. Visual acuity of the study eye was 20/400 or better.

Additional Patient Eligibility Criteria for the Foveal Study:

Only patients with AMD were eligible for this study. Fluorescein angiography of the eligible eye had to show evidence of a leaking choroidal neovascular membrane, some part of which extended under the center of the FAZ, or a neovascular lesion consisting of an old laser treatment scar and contiguous leaking neovascularization within 150 microns of the center of the FAZ. New, never-treated subfoveal lesions were less than four disc areas in size. Recurrent lesions were less than six disc areas in size, including the old treatment scar and new neovascularization. Best-corrected visual acuity was no better than 20/40 and no worse than 20/320.

About this study

To evaluate laser treatment of choroidal neovascularization (CNV) through randomized, controlled clinical trials. The Macular Photocoagulation Study (MPS) consisted of three sets of randomized, controlled clinical trials. Change in best-corrected visual acuity from baseline was the primary outcome for all MPS trials. Other measures of vision are evaluated in each set of trials. The purpose of each is described below.

Argon Study: To determine whether argon blue-green laser photocoagulation of leaking abnormal blood vessels in choroidal neovascular membranes outside the fovea (200 to 2,500 microns from the center of the foveal avascular zone [FAZ]) is of benefit in preventing or delaying loss of central vision in patients with age-related (senile) macular degeneration (AMD), presumed ocular histoplasmosis (POH), and idiopathic neovascular membranes (INVM). A separate trial was conducted for each of the three underlying conditions.

Read more

Krypton Study: To determine whether krypton red laser photocoagulation of choroidal neovascular lesions with the posterior border 1 to 199 microns from the center of the FAZ is of benefit in preventing or delaying large losses of visual acuity in patients with AMD, POH, and INVM. A separate trial was conducted for each of the three underlying conditions.

Foveal Study: To determine whether laser photocoagulation is of benefit in preventing or delaying further visual acuity loss in patients with new (never treated) or recurrent (previously treated with laser photocoagulation) choroidal neovascularization under the center of the FAZ. Two separate trials, one for each type of lesion, were carried out.

Read the detailed description

In each randomized trial conducted by the MPS Group, focal laser photocoagulation was compared to observation without treatment. Patients were assigned to laser treatment or to observation with equal probability. The first set of MPS randomized trials, the Argon Study, focused on the effectiveness of photocoagulation with argon blue-green laser in eyes with discrete extrafoveal choroidal neovascularization. The study investigators, who began recruiting patients in 1979, estimated that 550 patients with AMD and 750 with POH would be required. Follow-up was to continue for 5 years to determine whether argon laser photocoagulation treatment could prevent or delay visual acuity loss in these patients.

After the initiation of the Argon Study, a new krypton red laser became available. The new wavelength offered theoretical advantages over the argon laser for treating CNV that extended inside the FAZ of the macula. The Krypton Study design was analogous to the Argon Study, with the investigation of three underlying conditions, except that CNV was closer to the FAZ center.

The third set of MPS clinical trials, the Foveal Study, was designed to determine whether laser photocoagulation was effective for delaying or preventing further visual acuity loss in AMD patients who have subfoveal CNV. Among patients assigned to laser treatment in the Foveal Study, argon laser treatment was compared with krypton red laser treatment of these lesions. The investigators originally projected that about 350 patients would be required for each clinical trial of the Foveal Study.

Being tested
Argon Blue-Green Laser Photocoagulation
Keywords
photocoagulation, argon blue-green laser, krypton red laser
Medical subject headings
Choroidal Neovascularization, Macular Degeneration, Histoplasmosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Argon Blue-Green Laser PhotocoagulationProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 1999 (estimated)
  2. Study startFeb 1979

Resources

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000158
Sponsor's protocol ID
NEI-60
Status last verified
Jun 2002
First submitted
23 Sep 1999
Last updated
24 Jun 2005
Results posted
No

Publications

  • Changing the protocol: a case report from the Macular Photocoagulation Study. Macular Photocoagulation Study Group. Control Clin Trials. 1984 Sep;5(3):203-16. doi: 10.1016/0197-2456(84)90024-2.

    PubMed 6488805

  • Hillis A, Maguire M, Hawkins BS, Newhouse MM. The Markov process as a general method for nonparametric analysis of right-censored medical data. J Chronic Dis. 1986;39(8):595-604. doi: 10.1016/0021-9681(86)90184-0.

    PubMed 3525597

  • Blackhurst DW, Maguire MG. Reproducibility of refraction and visual acuity measurement under a standard protocol. The Macular Photocoagulation Study Group. Retina. 1989;9(3):163-9.

    PubMed 2480626

  • Hawkins BS, Prior MJ, Fisher MR, Blackhurst DW. Relationship between rate of patient enrollment and quality of clinical center performance in two multicenter trials in ophthalmology. Control Clin Trials. 1990 Oct;11(5):374-94. doi: 10.1016/0197-2456(90)90177-4.

    PubMed 1963130

  • Argon laser photocoagulation for senile macular degeneration. Results of a randomized clinical trial. Arch Ophthalmol. 1982 Jun;100(6):912-8. doi: 10.1001/archopht.1982.01030030920003.

    PubMed 7046707

  • Argon laser photocoagulation for ocular histoplasmosis. Results of a randomized clinical trial. Arch Ophthalmol. 1983 Sep;101(9):1347-57. doi: 10.1001/archopht.1983.01040020349002.

    PubMed 6193771

  • Argon laser photocoagulation for idiopathic neovascularization. Results of a randomized clinical trial. Arch Ophthalmol. 1983 Sep;101(9):1358-61. doi: 10.1001/archopht.1983.01040020360003.

    PubMed 6193772

  • Fine SL. Early detection of extrafoveal neovascular membranes by daily central field evaluation. Ophthalmology. 1985 May;92(5):603-9. doi: 10.1016/s0161-6420(85)33995-7.

    PubMed 2409502

  • Recurrent choroidal neovascularization after argon laser photocoagulation for neovascular maculopathy. Macular Photocoagulation Study Group. Arch Ophthalmol. 1986 Apr;104(4):503-12. doi: 10.1001/archopht.1986.01050160059012.

    PubMed 2420315

  • Argon laser photocoagulation for neovascular maculopathy. Three-year results from randomized clinical trials. Macular Photocoagulation Study Group. Arch Ophthalmol. 1986 May;104(5):694-701.

    PubMed 2423061

  • Krypton laser photocoagulation for neovascular lesions of ocular histoplasmosis. Results of a randomized clinical trial. Macular Photocoagulation Study Group. Arch Ophthalmol. 1987 Nov;105(11):1499-507. doi: 10.1001/archopht.1987.01060110045029.

    PubMed 2445326

  • Chamberlin JA, Bressler NM, Bressler SB, Elman MJ, Murphy RP, Flood TP, Hawkins BS, Maguire MG, Fine SL. The use of fundus photographs and fluorescein angiograms in the identification and treatment of choroidal neovascularization in the Macular Photocoagulation Study. The Macular Photocoagulation Study Group. Ophthalmology. 1989 Oct;96(10):1526-34. doi: 10.1016/s0161-6420(89)32707-2.

    PubMed 2479899

  • Persistent and recurrent neovascularization after krypton laser photocoagulation for neovascular lesions of ocular histoplasmosis. Macular Photocoagulation Study Group. Arch Ophthalmol. 1989 Mar;107(3):344-52. doi: 10.1001/archopht.1989.01070010354023.

    PubMed 2466454

  • Krypton laser photocoagulation for neovascular lesions of age-related macular degeneration. Results of a randomized clinical trial. Macular Photocoagulation Study Group. Arch Ophthalmol. 1990 Jun;108(6):816-24. doi: 10.1001/archopht.1990.01070080058036.

    PubMed 1693496

  • Persistent and recurrent neovascularization after krypton laser photocoagulation for neovascular lesions of age-related macular degeneration. Macular Photocoagulation Study Group. Arch Ophthalmol. 1990 Jun;108(6):825-31. doi: 10.1001/archopht.1990.01070080067037.

    PubMed 1693497

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Argon Blue-Green Laser Photocoagulation in people with Choroidal Neovascularization and Macular Degeneration, run by National Eye Institute (NEI).

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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

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 NCT00000158, which also lists 37 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 24 Jun 2005.

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