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Submacular Surgery Trials (SST)

Purpose | Background | Description | Patient Eligibility | Recruitment Status | Current Status | Results | Publications | Resource Centers | NEI Representative

Purpose

Background

Age-related macular degeneration (AMD) with CNV is the most common cause of irreversible severe loss of vision in older adults. The Macular Photocoagulation Study (MPS) Group, sponsored by the National Eye Institute, demonstrated that laser treatment is effective for recurrent subfoveal CNV (that extends into the center of the macula) after laser treatment and for selected patients with subfoveal CNV who had no prior treatment. More recently, photodynamic therapy with verteporfin was shown to reduce the risk of moderate and server loss of vision in selected patients with subfoveal neovascularization associated with AMD. Choroidal neovascularization due to OHS affects adults of working age and may pose a lifelong risk of blindness to people who have characteristic scars ("histo spots") in the macula. It has been estimated that 2,000,000 people who live or have lived in the region of the United States in which histoplasmosis is endemic have characteristic histo spots and that 100,000 of them will lose vision in one or both eyes due to CNV. Fortunately, the effectiveness of laser photocoagulation for treating CNV due to OHS that is not subfoveal (i.e., not extending into the center of the macula) also has been demonstrated by the MPS Group in two randomized clinical trials. However, treated patients are at risk of subfoveal recurrence, and laser treatment cannot be applied to these patients or to other patients with OHS who present with subfoveal CNV in the absence of prior laser treatment.

Recently, alternative therapies to laser photocoagulation and photodynamic therapy have been proposed for the management of CNV and are intended to increase the chance of stabilizing or improving vision at a greater rate than with observation. The most promising of these alternatives at this time is surgical removal of the neovascular lesion, i.e., submacular surgery. The rationale for this surgical approach is that removal of the CNV may halt enlargement of the visual defect, spare photoreceptors in the central macula, and allow adjacent ocular structures to function normally. Data regarding the effectiveness of this approach is limited to reports of case series which suffer from the absence of untreated controls, limited number of cases evaluated, or lack of long term follow-up to assess the impact of recurrent CNV, delayed atrophy of the outer retina, and adverse outcomes such as cataract and retinal detachment, requiring additional treatment.

Description

The Submacular Surgery Trials comprise a set of multicenter, randomized clinical trials with the goal of determining whether surgical removal of subfoveal CNV stabilizes or improves vision more often than observation. A total of 19 clinical centers collaborated in conducting a clinical trial for patients with neovascular OHS and idiopathic CNV (Group H protocol). The target sample size for the Group H protocol was 250 participants to be enrolled and followed for 4 years. A total of 29 clinical centers collaborated in conducting two additional clinical trials for patients with neovascular AMD. The target sample size for these AMD trials was 960 participants to be enrolled and followed for 4 years.

Vision data collected at baseline include a protocol refraction, best-corrected logMAR visual acuity (ETDRS charts), contrast threshold (Pelli-Robson charts), and reading speed (enlarged text). Other baseline data recorded include stereoscopic color fundus photographs, fluorescein angiograms, and lens photographs, as well as health- and vision-related quality of life interview data (by telephone).

Eligible patients who gave signed, informed consent were randomly assigned to surgery (within 8 days of randomization) or observation. Patients, assigned to surgery, are seen one month post-surgery for an examination and photographs. All participants are examined at 3, 6, 12, 24, 36, and 48 months after randomization to collect vision data (collected in a masked fashion at 24 and 48 months after randomization) and to repeat photography. Quality of life telephone interviews are repeated at 6, 12, 24, 36, and 48 months after randomization.

The primary outcome is improvement in visual acuity from baseline to the two-year examination or retention of baseline visual acuity through the two-year examination. Secondary outcomes include change in quality of life from baseline to the 2- and 4-year examinations, change in visual acuity over 4 years, large losses of visual acuity, and adverse ocular outcomes (e.g., those requiring additional treatment such as cataract, retinal detachment, or recurrent CNV).

Patient Eligibility

Group B: Patients with evidence of large hemorrhages from subfoveal neovascular AMD lesions, visual acuity (SST protocol) of 20/100 to light perception, with the area of hemorrhage larger than the area of fluorescein angiographically visible CNV, with any visible CNV < 9 MPS disc areas, and ability to return for 4 years of follow-up may be eligible for the Group B (Blood) protocol.

Group N: Patients with new CNV (no prior laser) due to AMD, visual acuity (SST protocol) of 20/100 to 20/800, fluorescein angiographic evidence of subfoveal CNV lesion which is < 9 MPS disc areas, and ability to return for 4 years of follow-up may be eligible for the Group N (New CNV) protocol.

Group H: Patients with evidence of CNV due to OHS or idiopathic cause, visual acuity (SST protocol) 20/50 to 20/800, fluorescein angiographic evidence of subfoveal CNV lesion (new or recurrent) which is < 9 mps disc areas, and ability to return for 4 years of follow-up may be eligible for inclusion in the group h (histoplasmosis/idiopathic cnv) protocol. exclusion criteria include other ocular diseases compromising vision, history of submacular surgery in the study eye, history of subfoveal laser photocoagulation that extends under the foveal avascular zone, recent intraocular surgery, or previous investigational therapy for cnv.

Patient Recruitment Status

Recruitment of patients with neovascular AMD was completed on September 29, 2001. A total of 1,015 participants have been enrolled in all three trials.

Current Status of Study

Patient follow-up for Groups N, B, and H will end September 30, 2003

Results

None.

Publications

Dong LM, Hawkins BS, Marsh MJ: Consistency between visual acuity scores obtained at different distances: Theory vs. observations in multiple studies. Arch Ophthalmol 120: 1523-1533, 2002.

Bressler NM, Hawkins BS, Sternberg P Jr, McDonald HR: Are the submacular surgery trials (SST) still relevant in an era of photodynamic therapy?. Ophthalmology 108: 435-436, 2001.

Orr PR, Cramer LD, Hawkins BS, Bressler NM: Manifest refraction versus autorefraction for patients with subfoveal choroidal neovascularization. Invest Ophthalmol Vis Sci 42: 447-452, 2001.

Submacular Surgery Trials Pilot Study Investigators: Submacular Surgery Trials Randomized Pilot Trial of Laser Photocoagulation versus Surgery for Recurrent Choroidal Neovascularization Secondary to Age-Related Macular Degeneration: I. Ophthalmic Outcomes. SST Pilot Study Report No. 1. Am J Ophthalmol 130: 387-407, 2000.

Submacular Surgery Trials Pilot Study Investigators: Submacular Surgery Trials Randomized Pilot Trial of Laser Photocoagulation versus Surgery for Recurrent Choroidal Neovascularization Secondary to Age-Related Macular Degeneration: II. Quality of Life Outcomes.SST Pilot Study Report No. 2. Am J Ophthalmol 130: 408-418, 2000.

Grossniklaus, HE, Green, WR, for the Submacular Surgery Trials Research Group: Histopathologic and Ultrasructural Findings of Surgically Excised Choroidal Neovascularization. Arch Ophthalmol 116: 745-749, 1998.

Bressler NM: Submacular surgery: new information; more questions. Arch Ophthalmol 115: 1071-1072, 1997.

Bressler NM: Submacular surgery: Are randomized trials necessary?. Arch Ophthalmol 113: 1557-1560, 1995.

Resource Centers

Chairman's Office
Neil M. Bressler, MD
Chair, SST
The Johns Hopkins Medical Institutions
550 North Broadway, Suite 115
Baltimore, MD 21205-2010
Telephone: 410-502-5262
Fax: 410-614-8080
E-mail: pegorr@jhmi.edu

Paul Sternberg, Jr., MD
Vice-Chairman, SST
Vitreo-Retinal Surgery and Diseases
Department of Ophthalmology and Visual Sciences
8030 Medical Center East
Nashville, TN 37232
Telephone: (615) 936-1453
Fax: (615) 936-3497

Matthew A. Thomas, MD
Vice-Chairman, SST
Barnes Retina Institute
One Barnes Hospital Plaza, Suite 17413
St. Louis, MO 63110
Telephone: (314) 367-1181
Fax: (314) 367-0878

Eric B. Bass, MD, MPH
Economic Analyst, SST
Johns Hopkins University
School of Medicine, Department of Internal Medicine
8068 1830 Building
Baltimore, MD 21205
Telephone: (410) 955-9871
Fax: (410) 955-0825
E-mail: ebass@jhmi.edu

Peggy R. Orr, M.P.H., C.O.M.T.
Administrative Director, SST
The Johns Hopkins Medical Institutions
550 North Broadway, Suite 115
Baltimore, MD 21205
Telephone: (410) 502-5262
Fax: (410) 614-8080
E-mail: pegorr@jhmi.edu

Coordinating Center
Barbara S. Hawkins, PhD
Principal Investigator
Wilmer Clinical Trials and Biometry
The Johns Hopkins University
550 North Broadway, Ninth Floor
Baltmore, MD 21205-2010
Telephone: 410-955-8318
Fax: 410-955-0569
E-mail: bhawkins@jhu.edu

Pathology Center
Hans E. Grossniklaus, MD
Principal Investigator
L. F. Montgomery Eye Pathology Center
Emory Eye Center
1365-B Clifton Road, NE
Atlanta, GA 30322
Telephone: 404-778-4415
Fax: 404-778-4272
E-mail: ophtheg@emory.edu
http://www.wilmer.jhu.edu/refersst.htm

Photograph Reading Center
Susan B. Bressler, MD
Principal Investigator
The Wilmer Ophthalmological Institute
The Johns Hopkins Medical Institutions
550 North Broadway, Ninth Floor
Baltimore, MD 21205
Telephone: 410-955-8109
Fax: 410-732-7542
E-mail: sbressler@jhmi.edu

NEI Representative

Maryann Redford, DDS, MPH
National Eye Institute
National Institutes of Health
Executive Plaza South, Suite 350
6120 Executive Boulevard, MSC 7164
Bethesda, MD 20892-7164
Telephone: 301-496-5983
Fax: 301-402-0528
E-mail: maryann.redford@nei.nih.gov

Data and Safety Monitoring Committee

Argye I. Hillis, Ph.D. (Chair)
Texas A&M University
3640 Alta Vista
Waco, TX 76706
Telephone: 254-662-2410
Fax: 254-662-3867

Gary W. Abrams, M.D.
Kresge Eye Institute of Wayne State University
4717 St. Antoine
Detroit, MI 48201
Telephone: (313) 577-1355
Fax: (313) 577-1486

John E. Connett, Ph.D.
CCBR, Room 200
Division of Biometry
2221 University Avenue SE
Minneapolis, MN 55414
Telephone: (612) 626-9010
Fax: (612) 626-9054

Li Ming Dong, PhD
Wilmer Clinical Trials and Biometry
The Johns Hopkins University
550 North Broadway, Ninth Floor
Baltimore, MD 21205-2010
Telephone: (410) 955-8318
Fax: (410) 955-0569

Christine Grady, R.N., Ph.D.
National Institutes of Health
9000 Rockville Pike
Bldg. 10/1C118 MSC 1156
Bethesda, MD 20892-1156
Telephone: (301) 496-2429
Fax: (301) 496-0760

Earl Harrison
6336 Utah Avenue, N.W.
Washington, DC 20015-2434
Telephone: (202) 362-6331
Fax: (202) 362-5696

Lee M. Jampol, M.D.
Department of Ophthalmology
Northwestern University Medical School
645 N. Michigan Ave., Suite 440
Chicago, IL 60611
Telephone: (312) 908-8152
Fax: (312) 503-8152

Ex Officio Members



Neil M. Bressler, M.D.
The Johns Hopkins Medical Institutions
550 North Broadway, Suite 115
Baltimore, MD 21205
Telephone: (410) 502-5262
Fax: (410) 614-8080

Mary Ann Redford, DDS, MPH
National Eye Institute
National Institutes of Health
Executive Plaza South, Suite 350
6120 Executive Boulevard MSC 7164
Bethesda, MD
Telephone: (301) 496-5983
Fax: (301) 402-0528

Barbara S. Hawkins, Ph.D.
SST Coordinating Center
Wilmer Clinical Trials and Biometry
The Johns Hopkins University
550 North Broadway, Ninth Floor
Baltimore, MD
Telephone: (410) 955-8318
Fax: (410) 955-0569

Marta J. Marsh, M.S.
Wilmer Clinical Trials and Biometry
The Johns Hopkins University
550 North Broadway, Ninth Floor
Baltimore, MD
Telephone: (410) 955-8318
Fax: (410) 955-0569

Patient Centered Outcome Subcommittee

Carol M. Mangione, M.D., M.S.P.H.
UCLA School of Medicine
Department of Internal Medicine
911 Broxton Plaza, Room 119
Box 951736
Los Angeles, CA 90024
Telephone: (310) 794-2298
Fax: (310) 794-0723

Eric B. Bass, MD, MPH
Johns Hopkins University
School of Medicine
Department of Internal Medicine
8068 1830 Building
Baltimore, MD 21205
Telephone: (410) 955-9871
Fax: (410) 955-0825

Last Updated: 2/25/2003



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