Elsevier

Ophthalmology

Volume 111, Issue 11, November 2004, Pages 1967-1980
Ophthalmology

Original article
Surgery for subfoveal choroidal neovascularization in age-related macular degeneration: Ophthalmic findings* : SST report no. 11

https://doi.org/10.1016/j.ophtha.2004.07.021Get rights and content

Purpose

To present visual acuity (VA) and related findings from patients enrolled in one of the Submacular Surgery Trials (SST) evaluating surgical removal versus observation of subfoveal choroidal neovascularization secondary to age-related macular degeneration (SST Group N Trial).

Design

Randomized clinical trial.

Participants

Eligible patients had age-related macular degeneration with subfoveal choroidal neovascularization, some with a classic pattern on fluorescein angiography, and best-corrected VA (BCVA) of 20/100 to 20/800 in one eye (study eye) that had received no treatment in the macula. Any contiguous blood had to account for <50% of the total area occupied by the subfoveal lesion (maximum size, 9.0 disc areas [22.9 mm2]).

Methods

Randomization was stratified by VA and by clinical center. All patients were scheduled for study examinations at 3, 6, 12, and 24 months after enrollment for assessment of study outcomes.

Main outcome measure

A successful outcome was defined a priori to be either improvement of BCVA or VA no more than 1 line (7 letters) worse than baseline at the 24-month examination.

Results

Of 454 patients enrolled, 228 study eyes were assigned to observation and 226 to surgery. The percentages of eyes that had successful outcomes were similar in the 2 arms: 44% assigned to observation and 41% assigned to surgery. Median VA losses from baseline to the 24-month examination were 2.1 lines (10.5 letters) in the observation arm and 2.0 lines (10 letters) in the surgery arm. Median VA declined from 20/100 at baseline to 20/400 at 24 months in both arms. No subgroup of patients was identified in which submacular surgery led to better VA outcomes. In the surgery arm, 55 (39%) of 142 initially phakic eyes had cataract surgery by the 24-month examination, compared with 6 (5%) of 133 eyes in the observation arm. Rhegmatogenous retinal detachment occurred in 12 surgery eyes (5%) and 1 observation eye.

Conclusions

Submacular surgery, as performed in this clinical trial, did not improve or preserve VA for 24 months in more eyes than observation and is not recommended for patients with similar lesions.

This article contains additional online-only material available at http://www.ophsource.com/periodicals/ophtha.

Section snippets

Materials and methods

The members of an independent Data and Safety Monitoring Committee, appointed late in 1996 by the Director of the National Eye Institute (National Institutes of Health, U.S. Department of Health and Human Services, Bethesda, Maryland), reviewed findings from the SST pilot study for similar patients and approved the SST design and methods before enrollment of patients was initiated in the SST Group N Trial in July 1998. Institutional review boards at all participating institutions reviewed and

Results

From July 13, 1998 until accrual ended on September 30, 2001, 454 patients (454 eyes) enrolled in the SST Group N Trial; 226 patients were assigned to the surgery arm and 228 patients to the observation arm. Based on central review of baseline photographs and other baseline data, 77 eyes (17%) (41 in the surgery arm and 36 in the observation arm) were judged not to meet 1 or more of the strict criteria for eligibility. One eye in the surgery arm had baseline VA worse than Snellen equivalent

Discussion

The SST Research Group was unable to demonstrate any benefit to submacular surgery compared with observation with respect to VA, reading speed with enlarged text, or contrast threshold in eyes with subfoveal choroidal neovascularization and age-related macular degeneration enrolled and followed in the Group N Trial. Both VA and reading speed of study eyes declined over time in both treatment arms. Despite high rates of recurrent choroidal neovascularization, eyes in the surgery arm maintained

Acknowledgment

The Submacular Surgery Trials Research Group gratefully acknowledges the contributions of ophthalmologists who referred patients to the study and, in particular, of patients who enrolled, agreed to random assignment to treatment arm, and returned for scheduled follow-up examinations to benefit future patients.

References (46)

  • Argon laser photocoagulation for neovascular maculopathyFive-year results from randomized clinical trials

    Arch Ophthalmol

    (1991)
  • Laser photocoagulation for juxtafoveal choroidal neovascularizationFive-year results from randomized clinical trials

    Arch Ophthalmol

    (1994)
  • J. Bermig et al.

    Angiographic findings in patients with exudative age-related macular degeneration

    Graefes Arch Clin Exp Ophthalmol

    (2002)
  • Laser photocoagulation of subfoveal neovascular lesions in age-related macular degenerationResults of a randomized clinical trial

    Arch Ophthalmol

    (1991)
  • Laser photocoagulation of subfoveal recurrent neovascular lesions in age-related macular degenerationResults of a randomized clinical trial

    Arch Ophthalmol

    (1991)
  • Laser photocoagulation of subfoveal neovascular lesions of age-related macular degenerationUpdated findings from two clinical trials

    Arch Ophthalmol

    (1993)
  • Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfinOne-year results of 2 randomized clinical trials—TAP report 1

    Arch Ophthalmol

    (1999)
  • Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: two-year results of 2 randomized clinical trials—TAP report 2

    Arch Ophthalmol

    (2001)
  • Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: two-year results of a randomized clinical trial including lesions with occult with no classic choroidal neovascularization—Verteporfin in Photodynamic Therapy report 2

    Am J Ophthalmol

    (2001)
  • Recurrent choroidal neovascularization after argon laser photocoagulation for neovascular maculopathy

    Arch Ophthalmol

    (1986)
  • Persistent and recurrent neovascularization after krypton laser photocoagulation for neovascular lesions of age-related macular degeneration

    Arch Ophthalmol

    (1990)
  • Persistent and recurrent neovascularization after laser photocoagulation for subfoveal choroidal neovascularization of age-related macular degeneration

    Arch Ophthalmol

    (1994)
  • Interferon alfa-2a is ineffective for patients with choroidal neovascularization secondary to age-related macular degenerationResults of a prospective randomized placebo-controlled clinical trial

    Arch Ophthalmol

    (1997)
  • Cited by (0)

    Manuscript no. 240390.

    Pertinent financial interests reported by members of the SST Research Group are summarized in Appendix 2; individual statements are on file in the SST Chairman's Office, Baltimore, Maryland. The Submacular Surgery Trials are sponsored by the National Eye Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland (cooperative agreements U10 EY11547, EY11557, EY11558 with the Johns Hopkins University, Baltimore, Maryland). Participating clinical centers were supported by contracts with the Johns Hopkins University.

    [email protected]

    *

    A list of the members of the Group who contributed data for the 2 SST clinical trials for patients with age-related macular degeneration appears in “Appendix 1.” The members of the Writing Committee for this report who take responsibility for its content on behalf of the SST Research Group are included at the end of that list. Documentation of approval of the manuscript submitted for publication by all individuals listed is on file at the SST Coordinating Center, Baltimore, Maryland.

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