NCT01880788

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

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

2.3 years

First QC Date

May 16, 2013

Last Update Submit

September 17, 2015

Conditions

Keywords

Age Related Macular DegenerationChoroidal NeovascularizationCentral Serous Chorioretinopathy

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

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Study Sites (1)

Vitreous Retina Macula Consultants of New York

New York, New York, 10022, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buccal cells

MeSH Terms

Conditions

Macular DegenerationChoroidal NeovascularizationCentral Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

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

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

Locations