Complement Factor H Haplotypes and Smoking in Age-related Macular Degeneration

Completed

Conditions studied: Macular Degeneration

In brief

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 the investigators 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.

Key facts

Study ID

NCT01115231

Run by

VA Office of Research and Development

People needed

223

Starts

2010-10-01

Expected to finish

2016-12-31

Last updated by the study team

2019-09-30

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• The investigators 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.

Where it is running

• Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States
• Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States

Full record on ClinicalTrials.gov

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