Current Research at Retina Vitreous Consultants
The Physicians at Retina Vitreous Consultants are involved in several national research projects to help define newer treatments for several retinal conditions. Several of these studies are described below. You may be offered the opportunity to participate in one of these studies but you are never required to participate. If you choose not to participate we will still provide you with the best possible care.
Age Related Macular Degeneration Studies
The treatment of Age Related Macular Degeneration has changed in the last few years and the treatment will continue to improve in the next few years. The physicians at Retina Vitreous Consultants continue to be a part of this change through ongoing research.
CATT
The Comparison of AMD Treatment Trials (CATT) is a research trial designed to determine which of two widely used treatments for the wet form of AMD may be preferable. A monthly intravitreal injection of Lucentis® is the FDA-approved treatment. However, widespread implementation of a fixed, monthly dosing schedule may be inconvenient for patients, and is very expensive. There is some data suggesting less frequent administration of drug could be just as good, but we still don’t know for sure if a reduced dosing schedule is as effective as a fixed monthly schedule. Also, intravitreal injections of Avastin®, the antibody from which Lucentis® was derived, is a common off label drug employed by retina specialists to treat neovascular AMD. It is far less expensive than Lucentis. While it is widely used and there is a general consensus that it is an excellent drug, Avastin has not yet been evaluated in a controlled, randomized clinical trial. No one clinically has been able to determine which is the better drug. Hopefully this study will do so.
In the study patients will be assigned to receive either a Lucentis or Avastin injection into the eye, in either a fixed dosage schedule, or in a variable dosage schedule. It is hoped when the study is completed to learn which drug may be the better one to employ, and as well in what dose schedule.
Brimonidine for Geographic Atrophy from Age related Macular Degeneration
Geographic atrophy (GA) is the atrophic or dry form of Age Related Macular Degeneration. GA is present in 0.6% of people older than 50 years, 3.5% of people 75 years of age or older. GA is a major cause of both moderate and severe central visual loss and affects both eyes in more than half of people with this condition. GA usually progresses slowly over years and doesn’t cause substantial visual loss until late in the course of the disease. It can cause blank spots so that only a portion of a word or a facial feature is seen. However, when it progresses, there is severe central visual loss.
There is currently no established treatment to prevent GA or to slow its progression. There is a possibility that that Brimonidine will be effective in the treatment of GA. The neuroprotective action of this drug may reduce the rate of cell death in and around the retina. The neuroenhancement action of this drug may improve the function of the surviving retinal cells.
Ideally one would want sustained retinal drug levels to be adequate. Because other means of administering the drug don’t adequately get to the retina, or don’t last long enough in the eye, there is a drug delivery system which may allow the drug to last in the eye for many months. This system call Brimonidine PS DDS allows administration of the drug right in the office with an injection in a form which allows sustained release over time.
The goal of this study is to evaluate the safety and benefit of the Brimo PS DDS Applicator System (200 μg and 400 μg brimonidine tartrate) in patients with geographic atrophy (GA) from age-related macular Degeneration.
Pazopanib eye drops for Wet Age Related Macular Degeneration
The current standard treatment of Wet Age related Macular degeneration requires repeated injections of anti-VEGF medication directly into the eye. This revolutionary treatment has dramatically improved the prognosis of this condition. There are however infrequent complications of these injections and there is the inconvenience of frequent visits to the eye doctor for these injections.
Pazopanib is an anti-VEGF medication that is delivered to the eye by using a self administered eye drop instead of an injection. This is an early phase clinical trial to see if this form of treatment has some degree of efficacy. All patients entered in the study are given one of two doses of the drops which are placed in the eye two times a day. This is continued for only 28 days to measure the effectiveness of this drug. At the end of the 28 days standard treatment with injections is started. If it appears that the drops are not having the desired effect then standard treatment is started sooner.
Denali
Denali is a study which combines the current standard treatment with Lucentis with a previous common treatment Visudyne. Lucentis alone is superior to Visudyne alone but since they work differently the the combination of both treatments may be better than either treatment individually. Patients who participate in this study will have either Lucentis alone or Lucentis in combination with Visudyne. The combined treatment may decrease the number of Lucentis injections required.
AART
The AART study has recruited patients with wet macular degeneration in one eye and high risk advanced dry macular degeneration in the other. The study is designed to see if injections on the outside of the eye of the medication Anecortave Acetate will lower the risk of converting to wet macular degeneration. The study is currently fully subscribed and will last for four years.
AREDS 2
AREDS (Age Related Eye Disease Study) was completed in 2001 and this study revealed that certain high dose vitamins can reduce the progression of dry to wet macular degeneration. This follow-up study will evaluate additional supplements to see if they have additional benefit. All patients will receive the original vitamins which were proven to be helpful and some patients will receive Lutein and fish oil which may be helpful
Diabetic Retinopathy Studies
Lilly - MBCU-CS DME Diabetic Macular Edema: The effect of Ruboxistaurin, a medication taken orally, on diabetic macular edema which is very close to the center of the retina, and considered ‘clinically significant.’
Ruboxistaurin is a drug which has been shown to have certain beneficial effects on diabetic retinopathy. The central part of the retina is called the macula. When diabetes causes swelling in the center and adjacent to the center of the retina, it is called diabetic macular edema. Diabetic macular edema when it is clinically significant, can cause significant loss of central vision in only a few years time. In this study patients with diabetic retinopathy who have clinically significant macular edema but which has not yet causing swelling in the very center of the macula can be entered. The goal is to see if this drug can impact progression of retinopathy from diabetes by limiting progression of the swelling into the center of the retina.
Lilly - MBDL-NCS DME Diabetic Macular Edema: The effect of Ruboxistaurin, a medication taken orally, on diabetic macular edema which is further from the center of the retina, and is not yet considered ‘clinically significant.’
Ruboxistaurin is a drug which has been shown to have certain beneficial effects on diabetic retinopathy. The central part of the retina is called the macula. When diabetes causes swelling in the center and adjacent to the center of the retina, it is called diabetic macular edema. Diabetic macular edema when it is clinically significant, can cause significant loss of central vision in only a few years time. In this study patients with diabetic retinopathy which has not yet developed to the point it is very close to the center of the retina, and is therefore not yet clinically significant, can be entered. The goal is to see if this drug can impact progression of retinopathy from diabetes by limiting progression of the swelling into the center of the retina. Patients for whom progression occurs may undergo laser, the standard treatment for patients where the central part of the retina becomes involved with macular edema.
Allergan POSUDEX-DME Diabetic Retinopathy with Macular Edema Posurdex Implant Study:
Diabetes can lead to swelling of the macula, the central part of the retina. This can slowly take away central vision, making it difficult to watch television, drive, and read. The standard treatments for macular edema from diabetes has included local laser treatment. That retards the progression, but it usually doesn’t result in very much improvement of vision. The Posurdex trial involves injection into the eye of an extremely small piece of medicine designed for slow release. This has a steroid. The goal is to decrease edema. Patients who have had previous laser treatment [or patients who do not which to have laser] but still have swelling are possibly eligible for study entry
Retinal Vein Occlusion Studies
Retinal vein occlusion is the second leading cause of blindness in patients with retinal vascular disease following diabetic retinopathy. Blockage of a retinal vein obstructs the drainage of blood from the retina. This blockage causes increased pressure within the blood vessel causing blood and fluid to leak from the blood vessels into your retina. This accumulation of blood and fluid within the retina results in loss of vision and this loss varies in severity.
CRUISE and BRAVO
These studies evaluate Ranibizumab(Lucentis) for the treatment of a central retinal vein occlusion (CRUISE study) or a branch retinal vein occlusion (BRAVO study). Lucentis, the drug being administered in this research study has been approved by the FDA for the treatment of neovascular age-related macular degeneration. Lucentis may prevent blood and fluid from leaking out of the vessels and into the retina and may potentially help preserve vision in people with retinal vein occlusions.
Standard Care vs. COrticosteroid for REtinal Vein Occlusion Study
The SCORE Study is a multi-center, radomized Phase III trial designed to assess the efficacy and safety of standard care versus steroid (triamcinolone acetonide) injection(s) for the treatment of macular edema associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). This multi-centered study is sponsored by the National Eye Institute a branch of the National Institute of Health.
Allergan POSURDEX-BRVO Branch Retinal Vein Occlusion or Central Vein Occlusion with Macular Edema Posurdex Implant Study:
Previous Research at Retina Vitreous Consultants
The Physicians at Retina Vitreous Consultants have over several years been involved in many research trial to help define the best possible care of retinal diseases. The Physicians at Retina Vitreous Consultants have taken a part in the following studies which are now completed.
Age Related Macular Degeneration Studies
Genaera
The Orchid Study investigates treating wet macular degeneration using a medication named Squalamine that inhibits blood vessel growth underneath the retina. Patients are examined to determine if they meet the criteria for treatment and then are assigned to one of three treatment categories. The drug is infused weekly for four weeks then monthly thereafter for two years.
Veritas
This study is designed to compare two different combination treatments for wet macular degeneration. Visudyne treatment with injections of Triamcinolone(Kenalog) or Visudyne treatment with injections of Macugen. It is hoped that these two treatments will prove to yield better results than treatment with Visudyne alone. No patients will be receiving placebo. This study will last for 24 months with 10 scheduled visits during this time
Focus, Marina, Pier and Horizon
These studies evaluated a drug called Lucentis. This drug blocks a biological agent called VEGF which stops the growth of abnormal blood vessels that cause scar tissue. As a result of these studies this drug was approved for use by the FDA. This new treatment has dramatically changed the way we treat macular degeneration. Far fewer patients lose more vision once this treatment is begun and many will have some improvement.
Sailor
This was a study using Lucentis injections for wet macular degeneration in patients comparing two different doses of medication. This study further defined the benefits and the safety of Lucentis injection therapy in wet macular degeneration.
Previous clinical trials sponsered by the National Institute of Health (NIH)
Submacular Surgery Trials
(SST)
The Submacular Surgery Trials was a study to evaluate the role of surgery in the treatment of wet macular degeneration and younger patients with ocular histoplasmosis. RVC was one of 30 centers in study is sponsored by the National Eye Institute a branch of the National Institute of Health.
Collaborative Ocular Melanoma Study (COMS)
The Collaborative Ocular Melanoma Study (COMS) was a study that helped define the treatment of choroidal melanoma, the most common primary eye cancer affecting adults. Retina Vitreous Consultants was one of 40 centers throughout the country for this study supported by the National Eye Institute.
Endophthalmitis Vitrectomy Study (EVS)
The Endophthalmitis Vitrectomy Study was a study that helped define the optimal treament for patients that develop infections following cataract surgery. This study has changed the way many retina specialists treat such infections. This was a large multi-centered study sponsored by the National Eye Institute. Dr. Doft of Retina Vitreous Consultants was the chairman of this important study.
