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Latest Australian and International ResearchAustralian Bionic Eye CNTF Trials Landmark Gene Therapy Three young adults with virtually no vision can now read several lines on an eye chart and see better in dimly lit settings thanks to an innovative gene therapy aiming to reverse blindness in a severe form of retinitis pigmentosa known as Leber congenital amaurosis or LCA. One person was even able to better navigate an obstacle course several weeks after receiving the therapy. More...
Australian Bionic EyeAustralian opthamologists say they are well on the way to fulfilling the dream of implanting a permanent bionic eye into a patient. The idea was embraced by Prime Minister Kevin Rudd at the 2020 summit at the weekend of April 2008. But Professor Minas Coroneo from Sydney's Prince of Wales Hospital says work on the project is already well underway and they will implant a permanent bionic eye into a patient in the next few weeks. Early trials have shown the device can help people who are completely blind to see large objects.
CNTF TrialsThis study will evaluate the safety of a ciliary neurotrophic factor (CNTF) implant placed in the eye to allow the release of CNTF directly on the retina. The results of this study may lead to a larger investigation of CNTF implants to treat retinitis pigmentosa (RP), a progressive degenerative eye disease that begins with loss of peripheral vision and night blindness and often leads to blindness in later life. Currently, there are no effective treatments for RP. Researchers have found, however, that certain proteins, called ciliary neurotrophic factor (CNTF), can partially protect cells in the eye if given directly inside the eye. A major challenge in treating RP is to deliver medicine directly into the eye. One way to ensure that CNTF gets into the eye is to surgically place an implant inside the eye to release the protein. Patients 18 years of age and older with retinitis pigmentosa whose visual acuity is 20/100 or worse may be eligible for this study. Candidates will be screened with a medical history, physical examination, eye examinations, and eye photographs. The eye examination includes measurement of visual acuity and eye pressure, examination of the pupils and eye movements, and examination of the lens and back of the eye. In addition, patients will have the following tests: Visual field test: Patients look at a central spot on a white screen and tell the examiner whenever they see a small light appear at other places on the screen. Electroretinogram (ERG): Electrodes are taped to the patient's forehead. Special contact lenses are placed on the eyes, similar to normal contact lenses, after the eye has been numbed with drops. The contact lenses sense small electrical signals generated by the retina. The ERG measures the electrical activity of the retina when it is stimulated by light. For the ERG recording, the patient looks inside a large, hollow, dark sphere, and sees flashes of light, first in the dark, and then with a light turned on in the sphere. Optical coherence tomography: This test, done with the machine used to examine the eye, measures retinal thickness by producing cross-sectional pictures of the retina. Participants undergo surgery at the NIH Clinical Center in a 30-minute operation to place the implant in one eye. The surgery is done under local anesthetic. Before the procedure, patients are given a steroid injection along side the eye to minimize inflammation after surgery. Following the procedure, patients return for follow-up visits once a month for 6 months. At these visits, several of the exams described above are repeated to evaluate treatment effects and check for adverse side effects. After 6 months, the implant is surgically removed. Post-surgical care for both implant and explant surgeries include examinations the day and week after surgery to examine the wound, a high dose of steroid immediately after surgery, oral antibiotics for 7 days, and eye drops for 1 week to prevent infection and inflammation.
Landmark Gene TheopyLandmark Gene Therapy Provides Vision to Nearly Blind Young Adults. Jean Bennett, M.D., Ph.D., lead investigator of the study, with her husband, Albert Maguire, M.D., the study's lead surgeon. Three young adults with virtually no vision can now read several lines on an eye chart and see better in dimly lit settings thanks to an innovative gene therapy aiming to reverse blindness in a severe form of retinitis pigmentosa known as Leber congenital amaurosis or LCA. One person was even able to better navigate an obstacle course several weeks after receiving the therapy. The three individuals are participating in a Phase I clinical trial at The Children's Hospital of Philadelphia, which is funded in part by the Foundation Fighting Blindness. "I am overwhelmed with delight. We are delivering vision to people who were blind. This is the biggest advancement in the 37-year history of the Foundation Fighting Blindness," says Gordon Gund, Co-Founder and Chairman of the Foundation Fighting Blindness. "We have achieved an incredible milestone in curing blindness, and this advancement will help pave the way for the development of gene therapies to treat and cure a variety of retinal diseases including: retinitis pigmentosa, Stargardt disease, Usher syndrome, and macular degeneration. This is a great day for the Foundation and all people affected by blinding retinal diseases." The development of the approach began when a form of LCA was linked to the RPE65 gene in 1997. Three years later, researchers began giving vision to dogs born blind from LCA, including the world-famous Lancelot. More than 50 dogs have been treated and all continue to see well. The Foundation Fighting Blindness has been funding this research virtually every step of the way. Though the Phase I studies are primarily focused on safety, the first dose used in this study resulted in improved vision. An additional six individuals will be enrolled in a continuation of this study to evaluate safety and efficacy of differing doses. The vision improvement in young adults seen so far at the lowest dose gives researchers optimism that the treatment may provide near-normal vision to children in Phase II studies. Results of the clinical trials, funded in part by the Foundation, were published on April 28, 2008 in the New England Journal of Medicine. The journal published the results of gene therapy trials taking place at CHOP and Moorfields Eye Hospital in London. A third trial of the gene therapy, sponsored by the NEI, is also taking place at the University of Pennsylvania and the University of Florida. Jean Bennett, M.D., Ph.D., lead investigator of the CHOP trial, reports that the team studied three participants, who ranged in age from 19 to 26. All three had one eye treated. Bennett says that all three individuals reported improved vision in dimly lit environments and in visual acuity in their injected eyes starting two weeks after treatment. Nystagmus- the roving eye movement associated with severe vision loss from LCA- was also reduced in all three individuals. The treatment developed by this team of investigators involves delivery of a normal RPE65 gene to the retina to augment function of the defective RPE65 gene that leads to one form of LCA. Twelve different genes that lead to LCA have been identified. The gene is delivered using a therapeutic virus known as an adeno-associated vector or AAV. Researchers believe the vision improvement from a single injection will last for many years. In earlier laboratory studies, a single AAV-based gene therapy in more than 50 dogs born blind from LCA has been effective for more than seven years. This study is being carried out by an international team led by The University of Pennsylvania, The Children's Hospital of Philadelphia, the Second University of Naples and the Telethon Institute of Genetics and Medicine (both in Italy), and several other American institutions.
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