NCT00604071

Brief Summary

estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2007

Shorter than P25 for all trials

Geographic Reach
1 country

10 active sites

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

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

10 months

First QC Date

January 10, 2008

Last Update Submit

April 13, 2015

Conditions

Age Related Macular DegenerationChoroidal Neovascularization

Keywords

HMP, CNV, PHP, HPHP, AMD

Outcome Measures

Primary Outcomes (1)

  • estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD based on PRC grading of color stereo photographs and Stereoscopic fluorescein angiogram

    3 month

Secondary Outcomes (6)

  • Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD based in cases where both graders, prior to any adjudication process determined the presence of CNV

    3 month

  • Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD based on cases where both graders, prior to any adjudication process, and biomicroscopic finding determined the presence of CNV

    3 Month

  • Estimate the sensitivity of the HMP in identifying visual field functional defects in subjects with CNV secondary to AMD determined on biomicroscopy

    3 month

  • Estimate the sensitivity of the Amsler grid test in identifying functional changes in subjects with CNV secondary to AMD based on PRC grading of color stereo photographs and fluorescein angiograms.

    3 month

  • Estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD for each of three classifications of CNV lesions (occult, minimally classic and predominantly classic).

    3 month

  • +1 more secondary outcomes

Study Arms (1)

1

subjects with AMD related lesions: New onset (up to 60 days) non-treated CNV

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

62 completed subjects with new choroidal neovascularization AMD in at least one eye

You may qualify if:

  • Capable and willing to sign a consent form and participate in the study
  • subjects with AMD related lesions: New onset (up to 60 days) non-treated CNV
  • Age \>50 years
  • VA with habitual correction \>20/200 in study eye
  • Familiar with computer usage

You may not qualify if:

  • Evidence of macular disease other than AMD or glaucoma in the study eye
  • Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP, or FA
  • Any non-macular related ocular surgery performed within 3 months prior to study entry in the targeted eye
  • Inability to tolerate intravenous FA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Central Florida Retina Institute

Lakeland, Florida, 33805, United States

Location

Retina care specialists

Palm Beach Gardens, Florida, 33410, United States

Location

International Eye Center

Tampa, Florida, 33603, United States

Location

Center for Retina & Macular Disease

Winter Haven, Florida, 33880, United States

Location

Edina Retina Consultants

Edina, Minnesota, 55435, United States

Location

Retina Vitreous Center

New Brunswick, New Jersey, 08901, United States

Location

Foxman Foxman & Margolis

Northfield, New Jersey, 08225, United States

Location

Harkness Eye institute

West New York, New Jersey, 10032, United States

Location

Charlotte Eye Ear Nose & Throat

Charlotte, North Carolina, 28210, United States

Location

Virginia Retina Center

Leesburg, Virginia, 20176, United States

Location

Related Links

MeSH Terms

Conditions

Macular DegenerationChoroidal Neovascularization

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Neil Bressler, Prof.

    JHMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 29, 2008

Study Start

November 1, 2007

Primary Completion

September 1, 2008

Study Completion

November 1, 2008

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations

US(10)