LONDON--(BUSINESS WIRE)--Gyroscope Therapeutics Limited, a clinical-stage retinal gene therapy company, today announced the initiation of its Phase II programme evaluating its investigational gene therapy, GT005, for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). Dry AMD is a leading cause of permanent vision loss in people over the age of 50. GT005 is a one-time AAV-based gene therapy that is delivered under the retina. The goal of the Phase II clinical trial programme is to determine if GT005 has the potential to slow the progression of GA.
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Macular degeneration in its advanced form can cause loss of all central vision in both eyes. In the absence of other eye diseases, peripheral vision is maintained. Therefore, patients with advanced macular degeneration are, in most cases, able to see enough to get around within familiar surroundings. We have a large selection of products to help people with low vision, macular degeneration, retinitis pigmentosa, glaucoma and cataracts regain their visual independence. Our low vision electronic magnifiers are designed to assist you in many different low vision situations. Some are portable while others are designed to sit on a desk or table. Macular degeneration, also known as age-related macular degeneration (AMD or ARMD), is a medical condition which may result in blurred or no vision in the center of the visual field. Early on there are often no symptoms. Over time, however, some people experience a gradual worsening of vision that may affect one or both eyes. Macular degeneration is a top cause of vision loss, and at the moment, it is considered incurable. However, researchers are working hard to understand the cause of macular degeneration, and recently, several new types of treatment have been developedDoctors can now use a new type of lens to help patients with macular degeneration, and that lens can magnify images before they reach the optic.
Gyroscope plans to conduct two Phase II trials evaluating GT005 in people with GA. The first, called EXPLORE, is enrolling people who have a mutation in their Complement Factor I (CFI) gene [NCT04437368]. The first patient to receive GT005 in EXPLORE was enrolled and dosed by Dr. Arshad M. Khanani at Sierra Eye Associates in Reno, Nev., USA.
“Geographic atrophy is a devastating diagnosis, as there are no approved treatments for this gradual and irreversible loss of vision,” said Arshad M. Khanani, M.D., M.A., Director of Clinical Research at Sierra Eye Associates and Clinical Associate Professor at the University of Nevada, Reno School of Medicine, and an investigator in the EXPLORE trial. “We are excited to participate in this trial evaluating GT005 for the potential to slow progression of geographic atrophy. We believe one-time gene therapies could be a major advancement in the field of retinal disease.”
GT005 is designed to restore balance to an overactive complement system, a part of the immune system, by increasing production of the CFI protein. An overactive complement system has been implicated in the development of AMD. The CFI protein regulates the activity of the complement system. It is believed that increasing CFI production will dampen the system’s overactivity and reduce inflammation, with the goal of preserving a person’s eyesight.
Research has found that approximately 3% of people with dry AMD have certain CFI mutations that correlate with low CFI levels in the blood and a higher risk of developing AMD.1 Gyroscope estimates that more than 100,000 people with GA in the United States and EU5 European countries may have these mutations.1,2,3,4 The EXPLORE trial will evaluate GT005 in this group of people with mutations in their CFI gene.
Research has also shown that a small supplementation of CFI can normalise complement activity in the blood,5 suggesting GT005 may also be applicable for a broader group of people with GA. Windows 10 driver store cleanup. It is estimated that approximately one million people in the United States alone have GA.4 Gyroscope therefore plans to initiate a second Phase II trial in 2020 that will evaluate GT005 in a broader GA population.
“We are excited about the potential of GT005 for people with dry AMD. Research suggests GT005 may be best suited for people with certain mutations in their CFI gene. However, evidence also suggests it may have potential for a broader population of people with geographic atrophy,” said Nadia Waheed, M.D., MPH, Chief Medical Officer of Gyroscope. “We have designed our clinical programme to evaluate these groups in two distinct Phase II trials, with the goal of determining which patients GT005 may be most appropriate for and to further our understanding of the role of the complement system in AMD.”
About the EXPLORE Trial
EXPLORE is a Phase II, multicentre, randomised trial evaluating the safety and efficacy of GT005 administered as a single subretinal injection.
EXPLORE is enrolling people who are aged 55 or older and have a clinical diagnosis of GA secondary to dry AMD and who have a mutation of the CFI gene. People being screened for the trial will be genotyped for the mutations. Trial participants will be randomised to one of three treatment arms: GT005 dose 1, GT005 dose 2 or a control arm. Participants in the control arm will receive current standard of care. The primary endpoint of EXPLORE is progression of GA over 48 weeks. The study will also evaluate GT005 for various safety and tolerability measures. Gyroscope plans to enroll approximately 75patients at approximately 40 centres based in the United States, United Kingdom, Europe and Australia.
Gyroscope will announce details about the second Phase II trial of GT005 at a later date.
About Age-Related Macular Degeneration (AMD) and Geographic Atrophy (GA)
AMD is a leading cause of blindness affecting an estimated 196 million people globally.6 AMD typically affects people aged 50 and older, and causes a gradual and permanent loss of central vision that worsens over time.7 There are no approved treatments for the dry form of AMD, which is the most common, impacting approximately 90% of people with the disease.8 As dry AMD advances it leads to GA, an irreversible degeneration of retinal cells. This vision loss can be devastating, severely impacting a person’s daily life as they lose the ability to drive, read and even see the faces of loved ones.
Samsung yp t9j manual. About Gyroscope Therapeutics: Vision for Life
Gyroscope Therapeutics is a clinical-stage retinal gene therapy company developing and delivering gene therapy beyond rare disease to treat a leading cause of blindness, dry AMD. Our lead investigational gene therapy, GT005, is a one-time therapy delivered under the retina. GT005 is designed to restore balance to an overactive complement system by increasing production of the Complement Factor I protein. GT005 is currently being evaluated in a Phase I/II clinical trial called FOCUS and a Phase II clinical trial called EXPLORE.
Syncona Ltd, our lead investor, helped us create the only retinal gene therapy company to combine discovery, research, drug development, a manufacturing platform and surgical delivery capabilities. Headquartered in London with locations in Philadelphia and San Francisco, our mission is to preserve sight and fight the devastating impact of blindness. For more information visit: www.gyroscopetx.com and follow us on Twitter (@GyroscopeTx) and on LinkedIn.
References
1 Kavanagh D, Yu Y, Schramm EC, et al. Rare genetic variants in the CFI gene are associated with advanced age-related macular degeneration and commonly result in reduced serum factor I levels. Hum Mol Genet. 2015;24(13):3861-3870.
2 Data on File.
3 Friedman DS, O'Colmain BJ, Muñoz B, et al. Prevalence of age-related macular degeneration in the United States [published correction appears in Arch Ophthalmol. 2011 Sep;129(9):1188]. Arch Ophthalmol. 2004;122(4):564-572.
4 Rudnicka AR, Kapetanakis VV et al. Incidence of late-stage age-related macular degeneration in American whites: systematic review and meta-analysis. Am J Ophthalmol 2015;160:85-93.
5 Lachmann PJ, Lay E, Seilly DJ, Buchberger A, Schwaeble W, Khadake J. Further studies of the down-regulation by Factor I of the C3b feedback cycle using endotoxin as a soluble activator and red cells as a source of CR1 on sera of different complotype. Clin Exp Immunol. 2016;183(1):150-156.
6 Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–116.
7 National Eye Institute. Age-Related Macular Degeneration. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/age-related-macular-degeneration. Accessed July 16, 2020.
8 Centers for Disease Control and Prevention. Age-Related Macular Degeneration. https://www.cdc.gov/visionhealth/basics/ced/. Page last reviewed June 3, 2020. Accessed August 4, 2020.
https://www.nih.gov/coronavirus.2 Data on File.
3 Friedman DS, O'Colmain BJ, Muñoz B, et al. Prevalence of age-related macular degeneration in the United States [published correction appears in Arch Ophthalmol. 2011 Sep;129(9):1188]. Arch Ophthalmol. 2004;122(4):564-572.
4 Rudnicka AR, Kapetanakis VV et al. Incidence of late-stage age-related macular degeneration in American whites: systematic review and meta-analysis. Am J Ophthalmol 2015;160:85-93.
5 Lachmann PJ, Lay E, Seilly DJ, Buchberger A, Schwaeble W, Khadake J. Further studies of the down-regulation by Factor I of the C3b feedback cycle using endotoxin as a soluble activator and red cells as a source of CR1 on sera of different complotype. Clin Exp Immunol. 2016;183(1):150-156.
6 Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–116.
7 National Eye Institute. Age-Related Macular Degeneration. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/age-related-macular-degeneration. Accessed July 16, 2020.
8 Centers for Disease Control and Prevention. Age-Related Macular Degeneration. https://www.cdc.gov/visionhealth/basics/ced/. Page last reviewed June 3, 2020. Accessed August 4, 2020.
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' href='/art/large/age-related-macular-degeneration.png' target='_blank'>mainly affects central vision, which is needed for detailed tasks such as reading, driving, and recognizing faces. The vision loss in this condition results from a gradual deterioration of light-sensing cells in the tissue at the back of the eye that detects light and color (Credit: Alila Medical Media/Shutterstock.com
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Projector For Macular Degeneration Vision
' href='/art/large/structure-of-the-retina.jpeg' target='_blank'>the retina). Specifically, age-related macular degeneration affects aCredit: National Eye Institute/National Institutes of Health
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' target='_blank' href='/art/large/retina-age-related-macular-degeneration.png'>small area near the center of the retina, called the Credit: National Eye Institute/National Institutes of Health
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' href='/art/large/normal-eye-anatomy-2.png' target='_blank'>Researchers have described two major types of age-related macular degeneration, known as the dry form and the wet form. The dry form is much more common, accounting for 85 to 90 percent of all cases of age-related macular degeneration. It is characterized by a buildup of yellowish deposits called drusen beneath the retina and vision loss that worsens slowly over time. The most advanced stage of dry age-related macular degeneration is known as geographic atrophy, in which areas of the macula waste away (atrophy), resulting in severe vision loss. Dry age-related macular degeneration typically affects vision in both eyes, although vision loss often occurs in one eye before the other.
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In 10 to 15 percent of affected individuals, the dry form progresses to the wet form of age-related macular degeneration. The wet form is characterized by the growth of abnormal, fragile blood vessels underneath the macula. These vessels leak blood and fluid, which damages the macula and makes central vision appear blurry and distorted. The wet form of age-related macular degeneration is associated with severe vision loss that can worsen rapidly.
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' target='_blank'>Credit: Alila Medical Media/Shutterstock.com
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' target='_blank'> Frequency
It is estimated that 8 percent of people around the world have signs of age-related macular degeneration. The condition currently affects about 11 million Americans and 170 million people worldwide, and the prevalence is expected to increase over the coming decades as the proportion of older people in the population increases.
For reasons that are unclear, age-related macular degeneration affects individuals of European descent more frequently than African Americans in the United States.
Related Information
Causes
Researchers have considered changes in many genes as possible risk factors for age-related macular degeneration. The best-studied of these genes are involved in a part of the body's immune response known as the complement system. This system is a group of proteins that work together to destroy foreign invaders (such as bacteria and viruses), trigger inflammation, and remove debris from cells and tissues. Genetic changes in and around several complement system genes, including the CFH gene, contribute to a person's risk of developing age-related macular degeneration. It is unclear how these genetic changes are related to the retinal damage and vision loss characteristic of this condition.
Changes on the long (q) arm of chromosome 10 in a region known as 10q26 are also associated with an increased risk of age-related macular degeneration. The 10q26 region contains two genes of interest, ARMS2 and HTRA1. Changes in both genes have been studied as possible risk factors for the disease. However, because the two genes are so close together, it is difficult to tell which gene is associated with age-related macular degeneration risk, or whether increased risk results from variations in both genes.
Other genes that are associated with age-related macular degeneration include genes involved in transporting and processing high-density lipoproteins (HDL, also known as 'good' cholesterol) and genes that have been associated with other forms of macular disease.
Researchers have also examined nongenetic factors that contribute to the risk of age-related macular degeneration. Age appears to be the most important risk factor; the chance of developing the condition increases significantly as a person gets older. Smoking is another established risk factor for age-related macular degeneration. Other factors that may increase the risk of this condition include high blood pressure; heart disease; a diet that is high in fat, high in easily digested foods (high glycemic index), or low in certain nutrients (such as antioxidants and zinc); obesity; and exposure to ultraviolet (UV) rays from sunlight. However, it is unclear how these factors influence the risk of developing age-related macular degeneration.
Learn more about the genes associated with age-related macular degeneration
Related Information
Inheritance Pattern
An individual shares half his/her genes with each parent and each offspring. An individual shares an on average half his/her genes with each sibling
Credit: GeneReviews, University of Washington, Seattle
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' target='_blank' href='/art/large/first-degree-relative.jpeg'>first-degree Related Information
Diagnosis & Management Links
Genetic Testing Information (19 links)
- What is genetic testing?
- Genetic Testing Registry: Age-related macular
degeneration - Genetic Testing Registry: Age-related macular degeneration
1 - Genetic Testing Registry: Age-related macular degeneration
2 - Genetic Testing Registry: Age-related macular degeneration
3 - Genetic Testing Registry: Age-related macular degeneration
4 - Genetic Testing Registry: Age-related macular degeneration
5 - Genetic Testing Registry: Age-related macular degeneration
6 - Genetic Testing Registry: Age-related macular degeneration
7 - Genetic Testing Registry: Age-related macular degeneration
8 - Genetic Testing Registry: Age-related macular degeneration
9 - Genetic Testing Registry: Age-related macular degeneration
10 - Genetic Testing Registry: Age-related macular degeneration
11 - Genetic Testing Registry: Age-related macular degeneration
12 - Genetic Testing Registry: Age-related macular degeneration
13 - Genetic Testing Registry: Age-related macular degeneration
14 - Genetic Testing Registry: Macular degeneration, age-related,
15 - Genetic Testing Registry: Susceptibility to age-related macular degeneration, wet
type - Genetic Testing Registry: Susceptibility to neovascular type of age-related macular
degeneration
Research Studies from ClinicalTrials.gov (1 link)
ClinicalTrials.gov
Other Diagnosis and Management Resources (2 links)
- BrightFocus Foundation: Macular Degeneration
Treatment - Prevent Blindness: Age-Related Macular Degeneration (AMD) Test - Amsler
Grid
Related Information
Other Names for This Condition
- age-related maculopathy
- AMD
- ARMD
- macular degeneration, age-related
Related Information
Additional Information & Resources
Health Information from MedlinePlus (3 links)
- Encyclopedia: Macular Degeneration
(Image) - Encyclopedia: Macular Degeneration -
Age-Related - Health Topic: Macular
Degeneration
Genetic and Rare Diseases Information Center (1 link)
- Macular
degeneration
Additional NIH Resources (1 link)
- National Eye
Institute
Educational Resources (7 links)
- American Academy of
Ophthalmology - Centers for Disease Control and
Prevention - JAMA Patient
Page - MalaCards: macular degeneration, age-related,
1 - Merck Manual Consumer
Version - Orphanet: Age-related macular
degeneration - U.S. Department of Transportation: Driving When You Have Macular
Degeneration
Patient Support and Advocacy Resources (6 links)
- American Macular Degeneration
Foundation - BrightFocus
Foundation - Foundation Fighting
Blindness - MD
Support - Prevent Blindness: The AMD Learning
Center - Retina
International
Scientific Articles on PubMed (1 link)
PubMed
Catalog of Genes and Diseases from OMIM (15 links)
- MACULAR DEGENERATION, AGE-RELATED,
1 - MACULAR DEGENERATION, AGE-RELATED,
2 - MACULAR DEGENERATION, AGE-RELATED,
4 - MACULAR DEGENERATION, AGE-RELATED,
5 - MACULAR DEGENERATION, AGE-RELATED,
6 - MACULAR DEGENERATION, AGE-RELATED,
7 - MACULAR DEGENERATION, AGE-RELATED,
8 - MACULAR DEGENERATION, AGE-RELATED,
9 - MACULAR DEGENERATION, AGE-RELATED,
10 - MACULAR DEGENERATION, AGE-RELATED,
11 - MACULAR DEGENERATION, AGE-RELATED,
12 - MACULAR DEGENERATION, AGE-RELATED,
13 - MACULAR DEGENERATION, AGE-RELATED,
14 - MACULAR DEGENERATION, AGE-RELATED,
15 - NEUROPATHY, HEREDITARY, WITH OR WITHOUT AGE-RELATED MACULAR
DEGENERATION
Medical Genetics Database from MedGen (1 link)
- Age-related macular
degeneration
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