Age-Related Macular Degeneration
Age-Related Macular Degeneration (ARMD) is the leading cause of vision loss in Americans over the age of 60. Its most devastating visual effects are seen in the wet form of AMRD, where abnormal blood vessels form under the macula, causing bleeding and, ultimately, scar tissue formation. Lucentis (made by Genentech) is a new medication which has offered hope to many people with wet ARMD. While older treatments were designed to slow the progression of the disease, Lucentis can offer a substantial improvement in vision in 35-40% of patients, and very few lose any vision at all. Many patients have their ability to read and to drive restored.
Dr. Michels and Dr. Laviña were involved in the clinical trials which showed the efficacy of Lucentis since September 2003. These trials included the following distinct clinical studies: ANCHOR, PIER, SAILOR 1 and SAILOR 2. In fact, they were one of the leading centers in the nation in enrollment and retention of patients within several of the trials. Dr. Michels was one of the lead authors in the study, which led to the FDA approval of the medication in July 2006. The study was published in the New England Journal of Medicine.
For years, this sight-saving medication was only available within clinical trials. Since the approval of Lucentis by the FDA, it is available to any patient who may benefit from the treatment.
The doctors are currently recruiting patients for a new clinical trial for the development of a new medication for wet ARMD called VEGF Trap-Eye by the company Regeneron. You must be evaluated at the Retina Care Specialists office to learn if you are a candidate for the study, although many patients with wet ARMD are indeed candidates.
Early data suggest that VEGF is effective like Lucentis. However, it may need to be injected less frequently, perhaps every three or even six months. Currently, Lucentis is injected into the eye as part of a painless office procedure. It needs to be injected monthly, although some patients can have less-frequent injections after stabilization of the disease. In this trial, patients receive either Lucentis or VEGF trap. There is no placebo group, so all patients receive treatment. The other advantage to patients is that in early work with VEGF Trap-Eye, nearly 50% more patients achieved the 20/40 level of visual acuity than in the Lucentis trial. This suggests more ARMD patients will be able to achieve driver’s license vision!
In addition to the Regeneron trial, the doctors at Retina Care Specialists are working to improve upon the success of Lucentis. In another clinical trial involving a combination of lucentis and Posurdex, an injected steroid designed specifically for the eye (see below), the doctors of Retina Care Specialists are hoping to not only demonstrate visual results better than those shown with Lucentis alone but with less frequent use of either drug!
Dry Macular Degeneration
Dry macular degeneration progresses to the more severe wet form in 20% of cases. Currently, patients can do little to detect that change short of frequent visits to the office and daily monitoring of the Amsler grid. That is why Retina Care Specialists are always looking for something better for our patients! Retina Care Specialists are working with an Israeli company to test a new device that patients use from home to detect progression of dry ARMD to the wet type. You must be evaluated at the Retina Care Specialists office to learn if you are a candidate for the study, although many patients with dry ARMD are indeed candidates.
Allergan Dry Age-Related Macular Degeneration (AMD) Brimonidine Study
We have been very interested in studying a treatment for Dry Age- Related Macular Degeneration. Fortunately, after much effort we have been able to team with Allergan Pharmaceuticals to provide a study that could be beneficial to those patients that suffer from Dry Age -Related Macular Degeneration. The trial will test the effectiveness of a medicine called Brimonidine Tartrate in this disease. Brimonidine tartrate has been used in drop form for the treatment of glaucoma. Early research has shown Brimonidine can protect and even enhance the function of the retina and may be very helpful to those with the dry form of macular degeneration. We are excited to be able to offer this treatment to our patients. Please ask us any questions that arise.
Diabetic Retinopathy
Diabetic Retinopathy is the leading cause of blindness in Americans under the age of 60. Laser treatment is still the standard of care for diabetic macular edema as well as proliferative diabetic retinopathy. Although appropriate laser treatment is important, these treatments are mainly geared toward limiting the detrimental effects of diabetes in the eye. Unfortunately, even when laser is perfectly applied, the long-term history with this standard of care is that vision eventually declines. That is why Retina Care Specialists are always looking for something better for our patients!
We are involved in an exciting clinical trial which involves Lucentis for diabetic macular edema. It is called the RISE study. Lucentis, which has shown to be the most effective medication for wet macular degeneration in history, has shown promise in diabetic macular edema as well. In fact, Dr. Michels, Dr. Laviña and Dr. Gallogly have treated a number of patients with diabetic macular edema with promising results.
Sirolimus for Diabetic Macular Edema by Macusight
There is a promising new treatment that is less invasive than previous treatments for diabetic macular edema. In this study, a tiny amount of medicine is injected on the outside of the eye. The injection is given twice, three months apart. Within the study, patients can receive other treatments if necessary. The preliminary data looks very encouraging.
Regeneron for Diabetic Macular Edema (DME) Trial
We are excited to offer another promising treatment for diabetic macular edema. Anti-VEGF therapy has been shown to be effective in treating diabetic macular edema. A new study treatment called VEGF Trap-Eye has shown significant promise in treating macular degeneration and we feel it could be quite effective in treating diabetic macular edema because of its unique characteristics. Please feel free to ask us any questions you may have.
Retinal Vein Occlusions
Central and branch retinal vein occlusions are the third leading cause of retinal visual loss. When the veins in the retina become blocked, sometimes macular edema or swelling in the retina can occur. This causes blurred vision. Laser treatment can help some patients with macular edema from branch vein occlusions; however, the visual improvement with laser is usually modest. That is why Retina Care Specialists are always looking for something better for our patients! Retina Care Specialists have been involved in the clinical trial to investigate Posurdex for retinal vein occlusions. Posurdex, a sustained release steroid, has improved vision in patients with macular edema from retinal vein occlusions.
The BRAVO study (for branch retinal vein occlusions) and CRUISE (for central retinal vein occlusions) involve Lucentis for treating macular edema caused by these disorders. In these one-year studies, Lucentis is injected monthly for six months. Although one third of patients are assigned to a placebo group, all patients may receive treatment with Lucentis after six months.
Regeneron for Central Retinal Vein Occlusion (CRVO) Study
Another exciting study is currently enrolling for CRVO. Similar to macular degeneration, anti-VEGF therapy has been shown to be effective in treating CRVO. A new study treatment called VEGF Trap-Eye has shown significant promise in other eye diseases and we feel it could be quite effective in treating CRVO because of its unique characteristics. Please feel free to ask us any questions you may have.
If you would like to be evaluated for one of these studies or would like more information on the clinical trial studies that we are running, please contact us.
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