The  web site has detailed information on many other eye conditions.  Please feel free to visit our Home Page, check out other eye conditions on our Eye Conditions page or back to our Macular degeneration page. 

TREATMENT OPTIONS

FOR

MACULAR DEGENERATION

1. Laser Treatment for Wet ARMD 
   The Laser Controversy
   Laser  photocoagulation has been shown to prolong visual function by sealing leaky blood vessels. But in many cases, vision worsens after treatment or improves only for a short time. As one retina specialist said, "It gives patients poor vision to keep them from getting terrible vision." Patients should understand beforehand that in addition to destroying the unwanted blood vessels, the laser beam also burns out the photoreceptors lying above them. It creates an area of depressed vision called a scotoma, Without treatment, some patients central vision is destroyed almost overnight. Which is the lesser of two evils? Because of the difficult choices involved, consultation among the patient, the eye care provider and the retinal specialist needs to be clear and complete. The decision is a difficult one. The Macular Study Group, made up of 15 centers in the U.S., produced guidelines that predict what the outcome will be for the first year post-surgery and for the years after that. Their study concluded that some vision loss always occurs as a result of the treatment. But for some people, this loss was less than it would have been had the disease progressed unchecked. In general, after 18 months, vision in the treated and untreated eyes was about the same. However, in some cases, the treatment may have reduced or halted the deterioration.

2. Angiogenesis Inhibitors for Macular Degeneration
   Angiogenesis is the formation or growth of new blood vessels. In the most severe form of age-related macular degeneration (known as "wet" ARMD) abnormal angiogenesis occurs under the retina resulting in irreversible loss of vision. The loss of vision is due to scarring of the retina secondary to the bleeding from the new blood vessels. Only 10% of patients with age-related macular degeneration will grow abnormal blood vessels under their retinas and thus progress from the "dry" form to the "wet" form of ARMD.

   Current treatments for "wet" ARMD utilize laser based therapy to destroy offending blood vessels. However, this treatment is not optimal since the laser can permanently scar the overlying retina and the offending blood vessels often regrow. Recently, new trials have begun to investigate if angiogenesis inhibitors can effectively inhibit the growth of new vessels in age-related macular degeneration. The following is a list of companies with angiogenesis inhibitors in clinical trials:

   1) Alcon: Anecortave acetate given by periocular injection.
   2) Agouron: Prinomastat given orally.
   3) Genentech: Anti-VEGF antibody given by intravitreal injection.
   4) NeXstar/EyeTech: Anti-VEGF aptamer (NX-1838) given by intravitreal injection.
   
   

3. Photodynamic Therapy (PDT)
   
   

4. Transpupillary Thermotherapy (TTT) Photocoagulation
   Transpupillary thermotherapy (TTT) photocoagulation is a method of delivering heat to the back of the patient's eye using an 810 nm infrared laser (IRIS Medical OcuLight SLx). This creates a localized hyperthermia, a natural healing mechanism, which results in closure of choroidal vessels. TTT is commonly used worldwide as an effective treatment for ocular tumors such as retinoblastoma and choroidal melanoma.

   Preliminary results of TTT treatment in subfoveal occult choroidal neovascularization (CNV) in age-related macular degeneration (AMD), have shown to reduce subretinal fluid in about 90% of cases and stabilize or improve vision in about 75% of cases without the substantial side effects of laser photocoagulation performed at conventional settings.

   The study titled "Transpupillary Thermotherapy (TTT) Of Occult Subfoveal Choroidal Neovascular Membranes (CNV) In Patients With Age-Related Macular Degeneration" (shortened to TTT4CNV) is a prospective, randomized, sham-controlled, multi-center clinical trial intended to ultimately determine the effectiveness of TTT in the treatment of occult CNV caused by AMD when compared to no treatment.

5. Macular Translocation
   Macular translocation is a new surgical technique designed to move the area of the retina responsible for fine vision (macula) away from the diseased underlying layers (the retinal pigment epithelium and choroid). The macula is moved to an area where these underlying tissues are healthier. Consequently, safe treatment of the sick blood vessels [choroidal neovascularization (CNV)] with, for example, laser treatment can be performed without harming central vision.
   
   Two Surgical techniques are Used:
   In the first technique, the entire retina is cut 360 degrees around the periphery. It remains attached to the optic nerve at the back of the eye. Then, like an umbrella, the whole retina is rotated around the optic nerve and the macula becomes repositioned. The abnormal blood vessels once under the fovea are now outside of the center of vision and can be treated.
   
   In the second technique, no large retinal cuts or rotations are needed. Instead, the outer part of the eye-wall (the sclera) is shortened with sutures (stitches). This results in there being more retina than its underlying eye-wall. That is, when you look into the eye, the retina is wrinkled and folded. Then the surgeon flattens the retina over the shortened eye-wall, causing the macular retina to move away from the optic nerve toward the periphery. As with the first technique, the central macula has been moved. The abnormal blood vessels once under the fovea are now outside of the center of vision and can be treated.

   Complications: Possible complications of these techniques are retinal tears, retinal detachment, intraocular bleeding, infection and cataract formation. After surgery the abnormal vessels can re-grow and new subretinal neovascularization can develop. Most patients do not develop these complications.

   Results: Macular translocation has been shown beneficial in a few series of patients (phase-I studies), showing improvement of visual acuity in 30-40%, and stabilization of visual acuity in 15-30%. Controlled studies comparing this surgery to the natural course of the disease or to laser and photodynamic treatments are needed.

   Conclusion: Macular translocation is a new and possibly helpful method in treating patients with subfoveal CNV with a unique potential to improve visual acuity. Randomized controlled (statistically significant) clinical studies are needed to evaluate the effectiveness and safety of macular translocation for treating visual loss from AMD and to compare it to other techniques.
   
   

6. Retinal Transplants and Implants
   Recently, this office has received a number of inquiries from people who listened to a brief broadcast news report about retinal transplants. Apparently , the newscast gave many people the impression that a new way to restore lost or impaired vision was about to become available. The purpose of this report is to respond to those inquiries.
   
   Some researchers do indeed think that it may one day be possible to restore some degree of vision to people with damaged or malfunctioning retinas, by placing in their eyes either retinal transplants or retinal implants.
   
   What is a retinal transplant?
   A retinal transplant is a graft of "good" retina tissue onto a non-working retina. The retinal transplant tissue might originate from another human, perhaps just deceased, or an aborted fetus. Less likely origins of the tissue to be transplanted are human retina tissue which has proliferated in culture; or retina tissue from another animal species.
   
   In order for a retinal transplant to work, several technologies which do not yet exist have to be developed:
   
   1.The cells in the transplant must stay alive for a long time, preferably for the life of the recipient.
   2.Those cells must have, and maintain, the light-sensing activities of normal, healthy retina cells.
   3.Those cells must transmit electric or electrochemical signals to the brain, which the brain can interpret as the experience of vision.
   
   A handful of laboratories are currently trying to develop retinal transplant technology, or are doing the research on which such technology might eventually be based (see links at the end of this page). Ophthalmic surgeons are still at the stage of testing techniques for placing transplants in the retina. Methods for getting retinal transplants to stay healthy will most likely get worked out first in an animal species other than humans. Some neuroscientists are trying to find conditions under which retinal tissue such as what might be used in a transplant, will produce an electrical signal. The hope of some researchers is that if the transplant produces a 2-dimensional pattern of electrical signals in response to light, e.g. in the shape of an alphabetical character projected onto the transplant, the underlying retina which is not light-responsive will still be able to pick up the signal pattern from the transplant and transmit it to the brain.
   
   This research and development path is "high risk", meaning that it is full of pitfalls, with a high probability that the goal may not be reached.
   
   What is a retinal implant?
   A retinal implant is a prosthetic retina, i.e. a manmade device designed to approximately do the job of the retina.
   
   The concept currently being explored, principally in an overly publicized joint project of MIT & Harvard, but also in a project in Germany, is to develop a light-sensitive diode array which can be mounted on the retina. The person with the implant would wear on the head a miniature electronic camera mounted in a unit resembling glasses. The image formed in the camera would be transferred to the diode array implanted on the retina. The diode array would produce a two-dimensional pattern of electrical signals, which it is again hoped would be picked up by the underlying malfunctioning retina, and transmitted to the brain for interpretation as vision.
   
   This type of research is at an early stage: learning how to get electric signals from implants in an animal model, the eye of the rabbit.
   
   There is a related field called computer vision, which is concerned with developing electronic devices which approximate the light-responsive behavior of a retina. These silicon retinas can be used to give robots the ability to see. It is likely that much of prosthetic retina technology will come from that field. However, the major uncertainty again is: how to transmit a signal from the prosthetic retina to the brain which the brain can interpret as vision?
   
   The path to a successful retinal implant device is high risk, like the path to a successful retinal transplant technique. It will be many years before we know if either path has been traversed successfully to its goal.

7. Regeneration of Retinal Cells
   Up untill now, macular degeneration has stubbornly resisted attempts to reverse its inexorable course. Sufferers are routinely told that nothing can be done and that they should resign themselves to a life restricted by fading central vision and low vision aids.

   All that has now changed. Fascinating new research reported May 4, 2000 at the Annual Meeting of the Association for Research in Vision and Ophthalmology revealed remarkable progress made towards detecting and deploying resting omnipotent cells in the eye and other tissues.

   The hope: to harvest resting omnipotent cells hiding in various sites in your body and inject them into diseased macular sites. These cells are then woken up, allowing them to grow and replace defective, dying or dead cells with new, vital and healthy ones.

   A slew of papers were presented documenting the discovery of so-called totipotential cells - cells that have the ability to turn themselves into any other specialized cell that they choose to.

   Specifically, scientists discussed the use of neural stem cells that proceed fully developed nerves and brain tissue. They injected these into the space beneath rat retinas and were able to stimulate them to grow into macular light sensing cells or photoreceptors after stressing these cells by reducing the blood supply to the retina and then increasing it.

   Rat visual acuity was not assessed before or after, so its unclear if these new photoreceptors were able to connect up the rest of the light sensing and transmission system.

   However, the demonstration that one can grow new photoreceptors in the adult eye is quite extraordinary, and was received with great enthusiasm at the conference.

   Other scientists injected neural stem cells into the vitreous, the gel-like substance bathing the retina that fills the globe of the eye and responsible for retaining its normal oval shape. Under controlled circumstances, the neural stem cells were able to find their way to the retina and change into photoreceptors.

   Other researchers demonstrated similar findings using even more primitive omni-potent cells – those called embryonic stems cells. First, they were cultured into embryonic bodies. These embryonic bodies were then transplanted into the sub-retinal space. Here, under the influence of retinoic acid (Vitamin A) and intermittent high and low blood flow stimulation they developed into photoreceptors.

   What are the implications of this research for patients with macular degeneration?

   First, this work explodes the myth that macular degeneration is irreversible. As the MDF has long held, it clearly is not. These landmark studies demonstrate that, in adult eyes, one can resurrect vision-related cells like photoreceptors and induce production of critical visual process dependent chemicals such as rhodopsin.

   Second it emphasizes the critical importance of more funding for omni-potent cell related research as the best hope yet for a cure for this disease. The MDF is redoubling its efforts to fund additional studies to broaden our understanding of these remarkable cells and develop the best ways to accelerate application of this new knowledge for humans.

   You can help us to help you or someone you love by contributing to the MDF Cells for Sight Initiative. Together we can help better fund the existing small group of researchers, enabling them to accelerate their work and add new talent and resources to the development of human therapies based upon this exciting discovery.
   

    

8. Rheopheresis  OccuLogix Corporation
   From the pilot study conducted at the University of Utah last year, it has been learned that certain patients with non exudative (Dry) AMD have elevated levels of some undesirable lipids (fats) and heavy proteins, like cholesterol and fibrinogen, in their blood. Furthermore, the data from this study suggested that if these patients were treated with the Rheofilter^TM MDF system, some of these patients obtained improved vision. The treatment involved the use of an apheresis blood filtering procedure used to deplete fats and heavy proteins from the blood. From the patient's perspective, the process is similar to donating blood. The idea is to use the blood filtering system to deplete heavy fats and proteins from the blood by obtaining several treatments spaced over a period of about 2 1/2-months. Theoretically, the sustained depletion of these unwanted fats and heavy proteins improves blood vessel function in the retina, and improves the blood flow to the macula, which may result in the patient obtaining better vision.

   Patients chosen to be included in this study, before beginning, will be required to undergo a qualifying examination that includes vital signs (heart rate, blood pressure, respirations and temperature), blood tests, a medical and ocular (eye) history, a complete physical and complete eye examination including eye photographs, and written questionnaires. If the patient qualifies, he or she will be asked to return for a visit within 3 weeks of the beginning of treatment.

   About 200 patients will be participating in the study at up to 10 centers across the country and the study will last approximately 12 months. Patients will be randomly assigned to one of two study treatment groups (either the Rheopheresis treatment group or the placebo treatment group). During the study, patients will not know which group they are assigned to, however there will be an approximate 2:1 chance of being in the apheresis treatment group. At the completion of the study, pending favorable study results, the patients who received the placebo treatment will be offered the Rheopheresis treatment free of charge.

   In either of these groups, patients will undergo 8 treatments over a period of about 2 1/2-months. Patients in the Rheopheresis treatment group will have their blood pumped through the filter system being investigated. Patients in the placebo treatment group will not have their blood filtered. At each visit, patients' vital signs will be recorded, and they will be asked to give blood samples for complete testing prior to and immediately after each treatment, which takes about 3 hours to complete. Between the 4th and 5th treatments and two weeks after the 8th treatment, patients will come back to the clinic for a visit where they will receive many of the same tests taken at the initial qualifying visit. There will be three more evaluations at approximately 6 months, 9 months, and 12 months. At those evaluations, the patients' blood will be tested and another complete set of ocular examinations will be performed.
   
   

9. Sub Macular Surgery with Tissue Plasminogen Activator (TPA). 
   Submacular surgery has been used in several ways to treat macular degeneration.  It was first used to wash out blood from beneath the retina when large hemorrhages occur.  Tissue Plasminogen Activator (TPA) has been used with the surgery to help dissolve the clot.  More recently, submacular surgery has been used to operate beneath the retina and remove the abnormal blood vessels ("membranes") that have grown.  While excellent results have been found for macular degeneration associated with Presumed Ocular Histoplasmosis Syndrome (POHS), Multifocal Choroiditis with Panuveitits (MPC) and Punctate Inner Chorioditis (PIC), the results with age-related macular degeneration have been less impressive.  Careful patient selection may improve success rates in age-related macular degeneration.  A randomized, controlled, multi-center clinical trial of submacular surgery is currently underway.
   
   

10.  

11.  

12.  

13.