Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01880788
Other study ID # SCMM-AMD-107
Secondary ID
Status Completed
Phase N/A
First received May 16, 2013
Last updated September 17, 2015
Start date November 2012
Est. completion date August 2015

Study information

Verified date September 2015
Source Sequenom, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date August 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 30 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
United States Vitreous Retina Macula Consultants of New York New York City New York

Sponsors (2)

Lead Sponsor Collaborator
Sequenom, Inc. Vitreous -Retina- Macula Consultants of New York

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
See also
  Status Clinical Trial Phase
Recruiting NCT03963817 - Snapshot Camera for AMD
Recruiting NCT04929756 - Eye Movement Rehabilitation in Low Vision Patients
Completed NCT04779398 - Association of MPOD Values With Blue Light.
Terminated NCT03275753 - Visual Function Tests in Age-related Macular Degeneration
Recruiting NCT03609307 - Comparison of Treatment Response to Intravitreal Injection of Combined Propranolol and Bevacizumab Versus Bevacizumab Monotherapy in Patients With Wet Age Related Macular Degeneration :A Clinical Trial Phase 2/Phase 3
Completed NCT02909985 - Visual Activity Evoked by Infrared in Humans After Dark Adaptation N/A
Completed NCT02556723 - Intravitreal Injections of Ziv-aflibercept for Macular Diseases N/A
Active, not recruiting NCT01943396 - Treatment of AMD With Rheohemapheresis /RHF/ Phase 4
Completed NCT00963339 - Age-Related Macular Degeneration (AMD) - Usability Study N/A
Completed NCT00376701 - Combination Therapy for Age-Related Macular Degeneration. Phase 2
Terminated NCT00347165 - Intravitreal Bevacizumab for Age-Related Macular Degeneration Phase 2
Completed NCT00800995 - Superoxide Dismutase (SOD) as Antioxidant Treatment OF Age Related Macular Degeneration (ARMD) Phase 3
Completed NCT04689789 - OCTA and Retinal Angiomatous Proliferation
Completed NCT02567604 - Development of Core Outcomes for Age-related Macular Degeneration (AMD) Interventions- Caregivers' Perspective
Completed NCT02173496 - Colour Contrast Sensitivity for the Early Detection of Wet Age-related Macular Degereration (CEDAR)
Recruiting NCT01991730 - Observational Study to Evaluate and Compare the Rate and Extent of Inflammation After a Single Injection of Ranibizumab vs. a Single Intravitreal Injection of Aflibercept in Treatment Naive and Treatment Experienced Patients N/A
Active, not recruiting NCT01657669 - Short-term Clinical Effects of Intravitreal Aflibercept Injection 2.0mg as a Predictor of Long-term Results Phase 4
Completed NCT00776763 - Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab Phase 2
Completed NCT00791570 - Anti-VEGFR Vaccine Therapy in Treating Patients With Neovascular Maculopathy Phase 1
Completed NCT00413829 - Immediate Effects of Lucentis® in Conjunction With Photodynamic Therapy With Visudyne® in Exudative AMD(IECOMB) Phase 2