Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 and/or 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 physician's 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00417846
Study type Observational
Source Johns Hopkins University
Contact
Status Completed
Phase N/A
Start date January 2007
Completion date August 2009

See also
  Status Clinical Trial Phase
Completed NCT01908816 - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. Phase 3
Completed NCT02015351 - Intravitreal Bevacizumab for the Treatment of CNV in VKH Disease - A Prospective Study N/A
Withdrawn NCT01666236 - Triple Treatment for Detachment of Retinal Pigment Epithelium Secondary to Polypoidal Choroidal Vasculopathy Phase 4
Completed NCT01175395 - 20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD) Phase 1/Phase 2
Terminated NCT00712491 - Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration Phase 1/Phase 2
Completed NCT00533520 - Evaluation of Dosing Interval of Higher Doses of Ranibizumab Phase 4
Completed NCT00242580 - A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib Phase 3
Completed NCT04075188 - Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid N/A
Not yet recruiting NCT05055973 - OCTA Insights in CNVM, Morphological Characteristics and Correlation With Structural OCT.
Recruiting NCT00568191 - Stratus Versus Cirrus OCT in AMD N/A
Completed NCT01256632 - Evaluation of the Effect of Vitreous Composition Determined by Ultrasound and Optical Coherence Tomography (OCT) on Ranibizumab Therapy N/A
Recruiting NCT00100087 - Safety Study for Treatment of Wet Macular Degeneration Using the TheraSight(TM) Ocular Brachytherapy System Phase 1/Phase 2
Completed NCT04455399 - Time Efficiency Comparison of Two IntraVitreal Injection Techniques N/A
Terminated NCT02857894 - Genetic Factors of Idiopathic Polypoidal Vasculopathies in the ATM Gene (Ataxia Telangiectasia Mutated)
Not yet recruiting NCT02934841 - Conbercept in Choroidal Neovascularization Secondary to Uveitis Phase 2
Completed NCT01880788 - Genetic Analysis of Chronic Central Serous Chorioretinopathy Masquerading as Neovascular AMD N/A
Completed NCT00775411 - Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD) Phase 2
Completed NCT00604071 - Sensitivity of the Home Macular Perimeter (HMP) N/A
Completed NCT00406250 - Intravitreal Bevacizumab in Agioid Streaks Phase 1
Withdrawn NCT00403156 - Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to Age-Related Macular Degeneration Phase 1