Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417846
Status:
COMPLETED
Last Update Posted:
2009-10-05
First Post:
2007-01-03
Brief Title:
Age-related Macular Degeneration Detection of Onset of New Choroidal Neovascularization AMD DOC Study
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Age-related Macular Degeneration Detection of Onset of New Choroidal Neovascularization AMD DOC Study
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the sensitivity of the optical coherence tomography OCT test in detecting neovascular AMD in eyes at high risk for CNV development In order to test this hypothesis we are conducting a multi-center clinical study at four participating clinical centers A total of 227 participants will be enrolled Participants will be followed-up for a period of two years or until CNV develops in the study eye for which treatment is recommended to determine the occurrence of CNV The fundamental design principles of the study are simplicity and parsimony
Detailed Description:
Primary Objective
The purpose of this study is to determine the sensitivity of the OCT in detecting conversion to neovascular AMD by two years in eyes at high risk for CNV with FA serving as the gold standard
Secondary Objectives
To determine the specificity positive predictive value and negative predictive value of the OCT in detecting conversion to neovascular AMD by two years in eyes at high risk for CNV with FA serving as the gold standard
To compare the sensitivity specificity positive predictive value and negative predictive value of the OCT to the PHP or the supervised Amsler Grid in subjects who had either negative PHP andor negative supervised Amsler grid at baseline for detection of neovascular AMD by two years in eyes at high risk for CNV
To describe features of false positives and false negatives with respect to baseline characteristics seen on PHP testing supervised Amsler grid testing and OCT imaging
To describe the relationship between new visual symptoms experienced by participants prompting an interim evaluation where treatment for CNV was recommended and findings seen at the previous study visit PHP testing supervised Amsler grid testing OCT imaging other findings on exam or fluorescein angiography as well as findings from the baseline visit
To determine the physicians detection of CNV development on return study visits including slit lamp biomicroscopy before viewing ancillary tests from that visit supervised Amsler grid PHP OCT fundus photographs fluorescein angiogram
All participants will be examined upon enrollment and then followed every three months after enrollment for two years or until conversion to CNV is positive and treatment is recommended Specifically follow-up visits will occur at 3 6 9 12 15 18 21 and 24 months from the date of the Initial Visit
The purpose of this study is to determine the sensitivity of the OCT in detecting conversion to neovascular AMD by two years in eyes at high risk for CNV with FA serving as the gold standard
Secondary Objectives
To determine the specificity positive predictive value and negative predictive value of the OCT in detecting conversion to neovascular AMD by two years in eyes at high risk for CNV with FA serving as the gold standard
To compare the sensitivity specificity positive predictive value and negative predictive value of the OCT to the PHP or the supervised Amsler Grid in subjects who had either negative PHP andor negative supervised Amsler grid at baseline for detection of neovascular AMD by two years in eyes at high risk for CNV
To describe features of false positives and false negatives with respect to baseline characteristics seen on PHP testing supervised Amsler grid testing and OCT imaging
To describe the relationship between new visual symptoms experienced by participants prompting an interim evaluation where treatment for CNV was recommended and findings seen at the previous study visit PHP testing supervised Amsler grid testing OCT imaging other findings on exam or fluorescein angiography as well as findings from the baseline visit
To determine the physicians detection of CNV development on return study visits including slit lamp biomicroscopy before viewing ancillary tests from that visit supervised Amsler grid PHP OCT fundus photographs fluorescein angiogram
All participants will be examined upon enrollment and then followed every three months after enrollment for two years or until conversion to CNV is positive and treatment is recommended Specifically follow-up visits will occur at 3 6 9 12 15 18 21 and 24 months from the date of the Initial Visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None