Serum Levels of Potential Biomarkers for Diabetic Retinopathy and Age-related Macular Degeneration

Study ID
Study00002019

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

Contact
Mike Molai
214-645-2014
mike.molai@utsouthwestern.edu

Principal Investigator
Yu-Guang He

Summary

Patients suffering from aMD will be selected to participate in this clinical trial. age and sex matched individuals without aMD will be served as controls. after review and execution of the consenting procedures, patient will undergo study procedures as described in the informed consent. The fasting blood sample will be obtained from the patients during their visit to the clinic. Blood will be immediately centrifuged and stored at -80 degree for biochemical analysis. Serum MDa levels will be determined using a fluorescence spectrophotometry and the results will be expressed as [MiCRo-SYMBoL]mol per liter. The levels between different study groups will be compared and analyzed statistically. overall, the Pi plans to recruit 1000 patients locally at uTSW Medical Center at Dallas in order to complete this trial. 900 patients who are diagnosed with aMD will be recruited while 100 subjects will serve as age, sex matched controls.

Study Procedures:
* a 16-ml blood sample will be acquired from each patient's arm following the informed consent process.
* For retrospective samples of patients with DR, serum obtained during previous visits and saved frozen, will also be used for this study. Consent will be obtained from these patients at their next scheduled visit to use their old serum samples for this study.
* For aMD patients that are not on vitamin-therapy (i.e. Vitamin a, C, e, Zinc, Copper, and Fish oil), the study doctor may consider placing him or her on therapy, as standard of care. Blood will still be drawn before initiating the therapy for a baseline sample. at the follow-up visit, the study doctor may draw an additional 1-2 tablespoons of blood to analyze any possible effects of being placed on vitamin therapy. no other follow-up care or treatment will be needed for this study.
* For Diabetic Retinopathy patients your expected study participation is one visit.
* Following collection, each sample will be centrifuged and serum separated immediately and stored at -80 degree Centigrade in laboratory for further analysis.
* The serum level of MDa will be assayed with a commercially available analyses kit. The levels from patients with and without aMD will be compared and analyzed. The levels among different type aMD (wet vs. dry, chronic vs. acute, and smoker vs. non-smoker, etc.) will also be analyzed.

Participant Eligibility

1. Patients of any sex and race, ages 18 and up. Spanish speaking patients will be encouraged to participate, Spanish forms will be available to review and execute.
2. Patient willing to review, understand, and sign written Informed Consent.
3. Written authorization for use or release of health and research study information
4. Systemically health patient volunteers suffering from moderate to severe case of AMD including
* dry
* and
* wet
* forms, at least in one eye.