N/A
N=223
Complement Factor H Haplotypes and Smoking in Age-related Macular Degeneration
Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT01115231 ↗Enrolled (actual)
223
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Age in Study Participants — 70.6; 77.8 years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Age in Study Participants |
70.6; 77.8 | — |
| SECONDARY Number of Participants That Are Smokers |
34; 31 | — |
| SECONDARY Number of Participants With Signal Nucleotide Polymorphisms for CFH Locus |
20; 10 | — |
| SECONDARY Percentage of Complement Pathway Proteins in the Serum |
95.3; 113.1; 103.7; 93.1; 94.7; 116.6 | — |
Summary
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.
Eligibility 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
- 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.
Data sourced from ClinicalTrials.gov (NCT01115231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.