NCT00000150

Brief Summary

To determine whether surgical removal of subfoveal choroidal neovascularization (CNV) and associated hemorrhage in patients with age-related macular degeneration (AMD), the ocular histoplasmosis syndrome (OHS), or idiopathic CNV stabilizes or improves vision more often than observation. To determine how surgical removal compared to observation of subfoveal CNV due to AMD, OHS, or idiopathic causes changes the patient's perception of health- and vision-related "quality of life," as measured by telephone interview using the Medical Outcomes Survey Short Form-36 (MOS SF-36) instrument, the Hospital Anxiety and Depression Scale, and the National Eye Institute Visual Function Questionnaire (NEI VFQ-25). To determine whether randomized trials of surgery are warranted for patients with subfoveal CNV associated with age-related macular degeneration not suitable for laser treatment.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 1999

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 23, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 1999

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2001

Completed
Last Updated

September 17, 2009

Status Verified

September 1, 2009

First QC Date

September 23, 1999

Last Update Submit

September 16, 2009

Conditions

Macular DegenerationHistoplasmosis

Keywords

Ocular Histoplasmosis SyndromeIdiopathic Choroidal Neovascularization

Interventions

Subfoveal Choroidal Neovascularization RemovalPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Grossniklaus HE, Green WR. Histopathologic and ultrastructural findings of surgically excised choroidal neovascularization. Submacular Surgery Trials Research Group. Arch Ophthalmol. 1998 Jun;116(6):745-9. doi: 10.1001/archopht.116.6.745.

    PMID: 9639442BACKGROUND

  • Hawkins BS, Bressler NM, Reynolds SM. Patient-reported outcomes among sham vs no-treatment controls from randomized trials. Arch Ophthalmol. 2011 Feb;129(2):200-5. doi: 10.1001/archophthalmol.2010.359.

    PMID: 21320967DERIVED

  • Submacular Surgery Trials Research Group; Solomon SD, Jefferys JL, Hawkins BS, Bressler NM, Bressler SB. Risk factors for second eye progression to advanced age-related macular degeneration: SST report No. 21 Submacular Surgery Trials Research Group. Retina. 2009 Sep;29(8):1080-90. doi: 10.1097/IAE.0b013e3181b1baeb.

    PMID: 19734762DERIVED

  • Solomon SD, Dong LM, Haller JA, Gilson MM, Hawkins BS, Bressler NM; SST research group and the SST adverse event review committee. Risk factors for rhegmatogenous retinal detachment in the submacular surgery trials: SST report No. 22. Retina. 2009 Jun;29(6):819-24. doi: 10.1097/IAE.0b013e3181a0857e.

    PMID: 19516120DERIVED

  • Hawkins BS, Bressler NM, Reynolds SM. Visual acuity outcomes among sham vs no-treatment controls from randomized trials. Arch Ophthalmol. 2009 Jun;127(6):725-31. doi: 10.1001/archophthalmol.2009.101.

    PMID: 19506188DERIVED

  • Bass EB, Gilson MM, Mangione CM, Hawkins BS, Miskala PH, Mann AL, Bressler NM. Surgical removal vs observation for idiopathic or ocular histoplasmosis syndrome-associated subfoveal choroidal neovascularization: Vision Preference Value Scale findings from the randomized SST Group H Trial: SST Report No. 17. Arch Ophthalmol. 2008 Dec;126(12):1626-32. doi: 10.1001/archopht.126.12.1626.

    PMID: 19064840DERIVED

  • Submacular Surgery Trials Research Group; Solomon SD, Jefferys JL, Hawkins BS, Bressler NM. Incident choroidal neovascularization in fellow eyes of patients with unilateral subfoveal choroidal neovascularization secondary to age-related macular degeneration: SST report No. 20 from the Submacular Surgery Trials Research Group. Arch Ophthalmol. 2007 Oct;125(10):1323-30. doi: 10.1001/archopht.125.10.1323.

    PMID: 17923538DERIVED

  • Submacular Surgery Trials Research Group. Evaluation of minimum clinically meaningful changes in scores on the National Eye Institute Visual Function Questionnaire (NEI-VFQ) SST Report Number 19. Ophthalmic Epidemiol. 2007 Jul-Aug;14(4):205-15. doi: 10.1080/09286580701502970.

    PMID: 17896299DERIVED

MeSH Terms

Conditions

Macular DegenerationHistoplasmosis

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesMycosesBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

January 1, 1999

Study Completion

September 1, 2001

Last Updated

September 17, 2009

Record last verified: 2009-09