Complement Factor H Haplotypes and Smoking in Age-related Macular Degeneration (CFH&AMD)
This study is currently recruiting participants.
Verified February 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01115231
First received: April 15, 2010
Last updated: February 6, 2013
Last verified: February 2013
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Purpose
Risk factors for Age-related Macular Degeneration (AMD) involves genetic variations in the alternative pathway of complement inhibitor factor H. The complement system is part of the innate and adaptive immune system. Smoking is the only environmental factor known to increase the risk of Age-related Macular Degeneration (AMD). Using serum samples of Age-related Macular Degeneration (AMD) patients and controls we will test the hypothesis that smoking increases Age-related Macular Degeneration (AMD) by increasing complement activation; and that this is positively correlated with known disease variations in the complement factor H (CFH) gene.
| Condition |
|---|
|
Macular Degeneration |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Complement Factor H Haplotypes and Smoking in Age-related Macular Degeneration |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
U.S. FDA Resources
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- Assessment of Age-related Macular Degeneration [ Time Frame: patients will be examined for AMD at a routine visit; if they present themselves with AMD or qualify as control, they will be recruited to the study. Information will be used in publication at the end of the 4-year study. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Visual field test [ Time Frame: Visual field test will be part of the patient's routine eye exam to determine why they complain about vision loss. Information will be used in publication at the end of the 4-year study. ] [ Designated as safety issue: No ]
- OCT [ Time Frame: OCT will be part of the patient's routine eye exam to determine why they complain about vision loss. Information will be used in publication at the end of the 4-year study. ] [ Designated as safety issue: No ]
- Fluorescein Angiography [ Time Frame: Day 1 of study. ] [ Designated as safety issue: No ]
- assessment of smoking status [ Time Frame: Day 1 of study ] [ Designated as safety issue: No ]
- Eye exam with fundus photography [ Time Frame: Day 1 of study. ] [ Designated as safety issue: No ]
- genotyping for signal nucleotide polymorphisms for I62V and Y402H in CFH gene [ Time Frame: within a month of obtaining blood sample ] [ Designated as safety issue: No ]
- Complement pathway protein analysis [ Time Frame: within a month of obtaining blood sample ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood will be collected into dipotassium ethylenediaminetetraacetic acid (EDTA) tubes resulting in a final EDTA concentration of 4.5 mM. Plasma will be separated from whole blood by centrifugation (10 minutes at 3000 RPM) and frozen at -80 degrees C until further use. Subjects will be genotyped for signal nucleotide polymorphisms for I62V and Y402H using TaqMan single nucleotide polymorphisms (SNP) genotyping assays. Complement pathway protein analysis will be performed by ELISAs.
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Group 1
Case control subjects will be recruited (150 persons). Controls are subjects without AMD diagnosis
|
|
Group 2
Case (i.e., within 5 years) subjects will be recruited (150 persons). Cases are defined as subjects with diagnosed AMD.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
The case and control subjects will be derived from a group of veterans at the Charleston, SC VA Medical Center.
Criteria
Inclusion Criteria:
- Inclusion criteria for subjects will be a clear diagnosis of Age-related Macular Degeneration (AMD)
- Inclusion criteria for controls will be less than five small (< 63 um) hard drusen
- At least a 20/40 view of the fundus
- The ability to provide a blood sample, and the absence of exclusion criteria listed
Exclusion Criteria:
- We will exclude individuals with ocular diseases that might simulate Age-related Macular Degeneration (AMD) or preclude its diagnosis.
- Those might include prior laser photocoagulation, cryopexy, media opacity, and inflammatory diseases.
- It is important for potential control subjects not to exhibit media opacity (e.g., cataract), which will prevent visualization of the macula.
- Also, subjects will be excluded if they exhibit diseases that phenotypically overlap with Age-related Macular Degeneration (AMD) such as drusen or pigmentary disturbance of the retinal pigment epithelium (RPE), or that provided insufficient evidence to diagnose Age-related Macular Degeneration (AMD).
- In addition, subjects with pattern dystrophies, toxoplasmosis, histoplasmosis, degenerative myopia, central serous chorioretinopathy, or any disease or treatment that would diminish the ability to recognize drusen such as laser photocoagulation, prior retinal detachment surgery, posterior uveitis, and trauma will be excluded.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115231
Contacts
| Contact: Baerbel Rohrer, PhD | (843) 789-6707 | rohrer@musc.edu |
| Contact: John Gross, MD | (843) 609-7564 | grossjd@musc.edu |
Locations
| United States, South Carolina | |
| Ralph H Johnson VA Medical Center, Charleston | Recruiting |
| Charleston, South Carolina, United States, 29401-5799 | |
| Contact: Baerbel Rohrer, PhD 843-789-6707 rohrer@musc.edu | |
| Principal Investigator: Baerbel Rohrer, PhD | |
| United States, Texas | |
| Michael E. DeBakey VA Medical Center, Houston, TX | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Faye Drexler 713-798-1414 ext 3717 fayep.drexler@va.gov | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Baerbel Rohrer, PhD | Ralph H Johnson VA Medical Center, Charleston |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01115231 History of Changes |
| Other Study ID Numbers: | C7428-R |
| Study First Received: | April 15, 2010 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Age-Related Macular Degeneration Age-Related Maculopathies Age-Related Maculopathy |
Macular Dystrophy Maculopathies, Age-Related Maculopathy, Age-Related |
Additional relevant MeSH terms:
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Complement Factor H |
Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013