Age Related Macular DegenerationNCT01880788
Genetic Analysis of Chronic Central Serous Chorioretinopathy Masquerading as Neovascular AMD
An observational study of Age Related Macular Degeneration and Choroidal Neovascularization, run by Sequenom, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Age Related Macular Degeneration, Choroidal Neovascularization, Central Serous Chorioretinopathy
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vitreous Retina Macula Consultants of New York
New York, New York, 10022
About this study
Official 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).
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.
Read the detailed description
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.
- Conditions
- Age Related Macular Degeneration, Choroidal Neovascularization, Central Serous Chorioretinopathy
- Keywords
- Age Related Macular Degeneration, Choroidal Neovascularization, Central Serous Chorioretinopathy
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization, Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CNV secondary to CSC | Not described | |
| CSC without CNV | Not described | |
| CNV secondary to advanced AMD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startNov 2012
- Primary completionMar 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequenom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vitreous -Retina- Macula Consultants of New York
- Responsible party
- Principal investigator, K. Bailey Freund, MD, Vitreous -Retina- Macula Consultants of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880788
- Sponsor's protocol ID
- SCMM-AMD-107
- Status last verified
- Sep 2015
- First submitted
- 16 May 2013
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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).
- ClinicalTrials.gov ID
- NCT01880788
- Acronym / sponsor ID
- SCMM-AMD-107
- Conditions
- Age Related Macular Degeneration, Choroidal Neovascularization, Central Serous Chorioretinopathy
- Keywords
- Age Related Macular Degeneration, Choroidal Neovascularization, Central Serous Chorioretinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Sequenom, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Vitreous -Retina- Macula Consultants of New York
- Study start
- Nov 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CNV secondary to CSC | – | – |
| CSC without CNV | – | – |
| CNV secondary to advanced AMD | – | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Caucasian
- 30 years and older (CSC)
- 50 years and older (Advanced AMD)
- Genders Eligible for Study: Both
- Completed Consent form
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration and Choroidal Neovascularization, run by Sequenom, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total genetic burden (time frame: Baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2015.