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OpenTrials
Completed

NCT Number: NCT01880788

Genetic Analysis of Chronic Central Serous Chorioretinopathy Masquerading as Neovascular AMD

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vitreous Retina Macula Consultants of New York

New York, 10022, United States

About this study

To determine if patients presenting with type 1 neovascularization believed to be secondary to CSC are genetically distinct from typical CSC patients without neovascularization or patients presenting with choroidal neovascularization (CNV) secondary to advanced AMD. Disease associated markers detecting variants in ARMS 2, Complement Factor H (CFH) Complement component 3 (C3), Complement component 2 (C2) , Factor B (FB), VEGFA or other genetic polymorphisms associated with CNV will be evaluated to determine if the CSC neovascular group is genetically distinct from the CSC group without neovascularization or the advanced AMD group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Caucasian
  • 30 years and older (CSC)
  • 50 years and older (Advanced AMD)
  • Genders Eligible for Study: Both
  • Completed Consent form
  • Diagnosis of choroidal neovascularization in at least one eye

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Total genetic burden

    Time frame: Baseline assessment

    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.

Sponsors and collaborators

Lead sponsor

Sequenom, Inc.

Industry

Collaborators

  • Vitreous -Retina- Macula Consultants of New York

Registry information

Official study title

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).

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 19, 2013
Registry last updated
Sep 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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