Posted on Sep.18, 2019, under Educational
A new clinical trial for those with dry age-related macular degeneration, called To Evaluate the Natural Progression of Dry Age-related Macular Degeneration (AMD), is currently recruiting 350 participants in eventually 28 study locations in the United States and Europe. Sponsored by Gyroscope Therapeutics, the study is seeking “to evaluate the natural progression of anatomical and functional visual parameters in genetically defined subjects with GA (Geographic Atrophy) due to AMD.” This study is an Observational Study which means that there is no treatment involved. Instead of receiving any type of therapy, participants will receive tests and imaging to observe anatomical changes of the retina and visual changes in those who have geographic atrophy which is an advanced stage of dry AMD.
Sponsor
The sponsor of the study is Gyroscope Therapeutics, an ophthalmology company headquartered in the United Kingdom, whose research focus is on gene therapy for eye diseases.
Eligibility
Those who are eligible to participate in the study are adults who have been diagnosed with geographic atrophy due to age related macular degeneration in one or both eyes. Study participants must have a Best Corrected Vision of 40 letters or better. Any history of wet macular degeneration or diabetic retinopathy will exclude a person from being eligible to participate.
Locations
There are 28 eye centers located from the east coast to the west coast in the United States as well as France, Germany, Spain, Netherlands and the United Kingdom that will be recruiting patients. Some study centers have started the recruitment process while others are still in the process and are not yet recruiting.
Tests
Some of the tests that will be performed are a color fundus, measurement of retinal drusen volume, a reading performance test measured in number of words read per minute, measurement of the area of geographic atrophy by Fundus Autofluorescence and measurement of any changes during the time frame of the National Eye Institute Visual Functioning Questionnaire. The study will also record any significant medical events. Saliva and blood samples will be taken as well.
Time Frame
When considering participating in a clinical trial, one needs to consider not only the convenience of the location of the study but how many visits are required over what time frame. In this study, patients will be monitored up to 96 weeks. How frequent the visits are to the study sites has not been shared.
Contact
If someone wants to know more about this observational study and if they meet the eligibility requirements, they can contact Gyroscope Therapeutics at this email address: [email protected]
To read more about this Dry AMD study you can visit the international listing of clinical trials at the National Institute of Health’s website:
To Evaluate the Natural Progression of Dry Age-related Macular Degeneration (AMD)
Leslie Degner, RN, BSN