Clinical Trials for Diabetic Macular Edema:
The macula is the small central part of the retina, which is responsible for straight-ahead vision. Over time, diabetes may affect the blood vessels that supply the eyes and those within the eyes. These weakened blood vessels begin to leak and cause swelling in the macula. As swelling increases, central vision decreases, making it harder to read, perform computer work, etc. The only FDA (Food and Drug Administration) approved treatment for diabetic macular edema (DME) is focal laser. Several new clinical trials are being conducted to determine a treatment or combination of treatments, which may be more effective than focal laser.
MACUSIGHT DIAMOND DR-002 - Currently enrolling. This trial is comparing several dosages of sirolimus to placebo as treatment for DME. Other clinical trials have shown sirolimus impedes many factors, which are responsible for new blood vessel growth.
DRCR LRT for DME - In follow-up. Laser in combination with ranibizumab, triamcinolone acetonide or sham for the treatment of DME. Ranibizumab is an anti- VEGF (vascular endothelial growth factor) drug. VEGF may play a role in the development of new blood vessels that form due to damage from diabetes. Triamcinolone acetonide is a steroid, which has been used off-label for the treatment of DME for several years. Sham treatments are not real injections into the vitreous; a needle-less syringe is placed on the eye to imitate an injection. The purpose of the trial is to determine whether the combination of drugs plus laser will be more effective than focal laser.
ALIMERA FAME - In follow-up. This trial uses an intravitreal steroid insert, which slowly releases the drug over time. Several doses are being compared as well as time to re-treatment between injections.
DRCR LRT for PDR with DME - Currently enrolling. PDR (proliferative diabetic retinopathy) is an advanced disease state in which new abnormal blood vessels begin to grow along the retina. The new blood vessels are weak and increase a patient’s risk of developing bleeding in the eye (vitreous hemorrhage). The usual treatment for patient’s who have developed PDR is pan retinal photocoagulation. This is a laser, which is applied to the periphery of the retina in an effort to reduce the risk of bleeding. This trial is comparing the use of PRP and focal laser in combination with a steroid or ranibizumab to the use of only PRP and focal laser.
Clinical Trials for Age-Related Macular Degeneration:
Age Related Macular Degeneration (AMD) is the leading cause of blindness in the world. There are two forms of AMD, dry and wet. With the dry form of AMD, patients have yellow deposits within the retina called drusen. Atrophy may develop from drusen that have been present for a long time causing the macula to thin and lead to slow progressive vision loss. Wet AMD is less prevalent but causes more severe vision loss if not diagnosed and treated. In wet AMD, new blood vessels grow under the retina. These new vessels are weak and may leak fluid and blood, causing swelling which usually decreases a person’s vision.
REGENERON VEGF-OD-0605 - Currently enrolling. Subjects may be treated with Lucentis or VEGF Trap. Lucentis and VEGF trap are drugs, which are classified as anti-VEGF (vascular endothelial growth factor) agents. VEGFs are responsible for the growth of blood vessels, which may leak and cause damage. The FDA has approved Macugen, PDT (photodynamic therapy) with Visudyne and Lucentis for the treatment of wet AMD.
AGE RELATED EYE DISEASE STUDY 2 - In follow-up. The AREDS trial led to the development of nutritional supplements, which help to reduce the risk of certain individual’s progression from dry AMD to wet AMD. The focus of this trial is the possible improvement of the original formulation by adding lutein (a substance found naturally in the macula) and omega 3 fatty acids.
MACUSIGHT EMERALD - Currently enrolling. A combination of sirolimus/ placebo with lucentis will be used for the treatment of subjects with AMD. Other clinical trials have shown sirolimus impedes many factors, which are responsible for new blood vessel growth.
Please contact our Research Department at crcresearch@bellsouth.net for more information of current or upcoming studies.
