Genetic Analysis of Chronic Central Serous Chorioretinopathy Masquerading as Neovascular AMD
Evaluation of Genetic Variants in Patients With Type 1 Neovascularization (Sub-retinal Pigment Epithelium Neovascularization) Who Lack Typical Findings of Age Related Macular Degeneration (AMD) But Present With Findings More Consistent With Long-standing Central Serous Chorioretinopathy (CSC).
1 other identifier
observational
152
1 country
1
Brief Summary
The study will be designed as a case control evaluation to compare the genetic profiles of three groups of patients categorized according to diagnosis. Group 1 - CNV secondary to CSC Group 2 - CSC without CNV Group 3 - CNV secondary to advanced AMD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 16, 2013
CompletedFirst Posted
Study publicly available on registry
June 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedSeptember 18, 2015
September 1, 2015
2.3 years
May 16, 2013
September 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total genetic burden
The identification of individual genetic markers or a quantitative measure of total genetic burden associated with CNV secondary to CSC vs. CSC vs. CNV secondary to advanced AMD as meaured by the commercially available RetnaGene AMD assay.
Baseline assessment
Study Arms (3)
CNV secondary to CSC
CSC without CNV
CNV secondary to advanced AMD
Eligibility Criteria
Patients seen for routine visits at the offices of Vitreous Retina Macula Consultants of New York. Enrollment will include 150 subjects: 50 will be selected based on diagnosis of CNV secondary to CSC 50 will be selected based on diagnosis of CSC without neovascularization and 50 selected based on diagnosis of CNV secondary to advanced AMD.
You may qualify if:
- Caucasian
- years and older (CSC)
- years and older (Advanced AMD)
- Genders Eligible for Study: Both
- Completed Consent form
- Diagnosis of choroidal neovascularization in at least one eye
You may not qualify if:
- Patient age less than 30 years (CSC).
- Patient age less than 50 years (AMD).
- Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD and CSC such as high myopia, retinal dystrophies, retinal vein occlusion, diabetic retinopathy and uveitis or similar outer retinal diseases which have been present prior to the age of 30.
- Opacities of the ocular media, limitations of pupillary dilation or other problems sufficient to preclude adequate fundus photography.
- Missing informed consent
- Previous sample donation under this protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sequenom, Inc.lead
- Vitreous -Retina- Macula Consultants of New Yorkcollaborator
Study Sites (1)
Vitreous Retina Macula Consultants of New York
New York, New York, 10022, United States
Biospecimen
Buccal cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor at NYU School of Medicine
Study Record Dates
First Submitted
May 16, 2013
First Posted
June 19, 2013
Study Start
November 1, 2012
Primary Completion
March 1, 2015
Study Completion
August 1, 2015
Last Updated
September 18, 2015
Record last verified: 2015-09