Wake Forest University Eye Center Participates in National
Age-Related Macular Degeneration Drug Study
The Eye Center at Wake Forest University Baptist Medical Center is one of nearly 100 clinical sites nationally that will evaluate the effects of antioxidants and fish oil on the progression of age-related macular degeneration (AMD). The goal of the study is to determine if these nutrients will decrease a person’s risk of progressing to advanced AMD. Previous observational studies have suggested these nutrients may protect vision.
“We are excited to participate in this study targeting the new combination of nutrients to help reduce the progression of age-related macular degeneration even further,” said Craig M. Greven, MD, professor and chairman of ophthalmology and principal investigator at Wake Forest University Baptist Medical Center. “This study may help people at high risk for advanced AMD maintain their vision longer and enhance their quality of life.”
The research, funded by the National Institutes of Health, is the second part of the Age-Related Eye Disease Study (AREDS) project. Five years ago, the first part of the project found that high-dose antioxidant vitamins and minerals (vitamins C and E, beta-carotene, zinc and copper), taken by mouth, reduced the risk of progression to advanced AMD by 25 percent, and the risk of moderate vision loss by 19 percent.
Now, the new study will add lutein and zeaxanthin, yellow pigments found in dark green, leafy vegetables such as spinach, collard greens, kale, mustard greens, and turnip greens, as well as the omega-3 fatty acids DHA and EPA, which are derived from fish and vegetable oils, to the study formulation. Lutein and zeaxanthin both accumulate in the macula, the part of the eye responsible for central vision, and researchers speculate that they may promote eye health through their ability to filter out ultraviolet light.
“It is essential that we determine which medications provide the best treatment for AMD,” said Greven. “The AREDS2 study will help us make more informed choices about treatment and, as a result, may maintain useful vision for a longer time.” Nearly 2 million Americans have vision loss from advanced AMD, and another 7 million with AMD are at substantial risk for vision loss. As AMD progresses, it blurs the patient’s central vision. AMD can take two forms: wet and dry. Wet AMD, caused by the abnormal growth of blood vessels under the macula, is considered to be advanced AMD and is more severe than the dry form. Dry AMD occurs when the light sensitive cells in the macula slowly break down. Untreated dry AMD can progress to wet AMD.
The AREDS2 study is seeking people between 50 and 85 years of age with AMD in both eyes or advanced AMD in one eye. Participants will receive study medications and a comprehensive clinical examination annually for at least five years. To find out if you qualify for AREDS2, call the study coordinator at (336) 716-6068.
PRINCIPAL INVESTIGATIONS
SCORE
The Standard Care vs. Corticosteroid for Retinal Vein Occlusion (SCORE) Study is a major NEI/NIH study involving 1,260 patients. The SCORE Study is designed as a multicenter, randomized, Phase III trial to compare the efficacy and safety of standard care versus triamcinolone acetonide injection(s) for the treatment of macular edema associated with CRVO and BRVO throughout the U.S. The Eye Center is currently enrolling new patients in this program.
Protocol EOP 1012C
This is our third study of the drug Macugen which was approved by the FDA in December 2004. It is Phase 4, randomized, active controlled, double-masked, single dummy, multi-center comparative trial, in parallel groups, to compare the safety and efficacy of intravitreous injections of Macugen® plus sham photodynamic therapy (PDT), to Macugen® plus PDT with Visudyne®, in subjects with predominantly classic subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) This study hopes to identify the most effective ways to treat subfoveal choroidal neovascularization in terms of individual or combined techniques. Enrollment is active.
Diabetic Retinopathy Clinical Research Network
This is a collaborative network sponsored by the NIH/NEI to facilitate multicenter clinical center research on diabetic retinopathy, diabetic m macular edema, and associated conditions.
1) Triamcinolone Study: A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema
Primary Objective: To determine whether intravitreal Triamcinolone Acetonide injections at doses of 1 mg or 4 mg produce greater benefit, with an acceptable safety profile, than macular laser photocoagulation in t he treatment of diabetic macular edema.
Secondary Objective: To compare the efficacy and safety of the 1 mg and 4 mg Triamcinolone Acetonide doses.
This is a randomized, multicenter trial of 795 patients. There are three treatment arms:
1) standard treatment of focal laser
2) intravitreal injection of 1mg Triamcinolone
3) injection of 4mg Triamcinolone
The study will last for three years. Primary outcome is >=15-letter improvement in vision and secondary outcome is retinal thickening. Enrollment is active.
2 )Laser Photocoagulation for DME:
This study is also conducted under the Diabetic Retinopathy Clinical Research Network.
The study protocol involves the enrollment of patients >18 years of age who have DME involving or threatening the center of the macula and who have not had prior focal/grid laser photocoagulation for DME. Eligible eyes will be randomly assigned to receive either the modified-ETDRS technique or the MMG technique. Outcome assessments will
include Optical Coherence Tomography (OCT), fundus photography, fluorescein angiography and standardized best-corrected visual acuity. The study is closed to enrollment and will conclude in 2006.
3 ) Evaluation of Vitrectomy for Diabetic Macular Edema:
This is our third study with the Diabetic Retinopathy Clinical Research Network. There will be 400 hundred subjects enrolled in this three year study. This study is designed as a prospective cohort study of evaluation of vitrectomy for diabetic macular edema. A cohort study provides the opportunity to collect data prospectively using a standardized protocol to assess the potential benefits and risks of vitrectomy. The results can be used to determine whether proceeding with a randomized trial has merit and what the design of the trial should be. If a randomized trial is to be conducted, the results plus the cohort study experience can be used to help design the protocol. Enrollment is active.
Protein Kinase C Inhibitor for Reduction of the Occurrence of Center-threatening Diabetic Macular Edema
This is the fourth study of the protein kinase C inhibitor (Ruboxistaurin) at the WFU Eye Center. Evidence has accumulated that implicates hyperglycemia-induced activation of protein kinase C beta (PKC b) in the development and/or progression of DME. Preclinical evidence also indicates that PKC b may play an important role in the development or progression of other diabetic complications such as diabetic nephropathy.
A selective PKC b inhibitor may reduce the progression and/or severity of DME progression as well as that of other diabetic complications. This is a 36-month study which began in March 2004 and enrolling 900 patients worldwide. We are currently enrolling patients.
VIOS Hypertension Study
This study addresses the accuracy of methodologies of photographic blood vessel caliber photo measurements as a less invasive way to measure the size of blood vessels when determining the effectiveness of hypertension medication and treatment. The study has great potential as a diagnostic tool. WFU Eye Center is working with Virginia Tech to develop a computer program to quantify the data.
Corneal Donor Study/JAEB Center
The Cornea Donor Study (CDS) is a prospective cohort study with the following major objectives:
• To determine whether the graft-failure rate over a 5-year follow-up period is equivalent with corneal tissue from donors older than 65 years of age compared with that from younger donors.
• To assess the relationship between donor: recipient ABO compatibility and graft failure due to rejection.
• To assess corneal endothelial cell density as an indicator of the health of the cornea and as a surrogate outcome measure (in an optional ancillary study).
If proven viable as graft material, corneas from older donors could help alleviate a perennial shortage of graft material. Patients are randomized to receive material from donors under and over age 65.
SUB-INVESTIGATIONS
ACCORD
The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Done with Endocrinology is an NIH-funded study to evaluate the effects of glycemic control, lipid control, and blood pressure on primary outcome of progression of diabetic retinopathy. The WFUBMC has three clinical sites for this study.
FIND
The Family Investigation of Nephropathy and Diabetes (FIND) is a NIH-study designed to identify genes responsible for diabetic nephropathy and their linkage relationships, if any, to nephropathy. The goal is to evaluate whether there is a genetic link between diabetic nephropathy and retinopathy .
MESA
The Multi-Ethnic Study of Atherosclerosis (MESA) is a NEI/NIH study with 6,500 patients enrolled nationally. This is an ancillary investigation aimed at evaluating the relation of retinal micro-vascular characteristics to the presence of sub-clinical cardiovascular disease, and the progression of sub-clinical cardiovascular disease in a multiethnic population.