Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Beacon Therapeutics
With
Foundation Fighting Blindness
The objective of the study is to evaluate subjects with XLRS in a clinical setting and gather data on disease progression. The data from this study will enhance the understanding of the natural history of this rare disease and will facilitate appropriately powered safety studies in a future gene therapy trial in humans.
Age
7–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Main Study:
Clinical diagnosis consistent with XLRS
Documented disease causing RS1 mutation
7 years of age or older
Able to provide informed consent/assent
Male
CAI sub-study:
Presence of maculoschisis
You may not be if
Main Study:
Other eye diseases that might affect the results (e.g. history of retinal detachment, glaucoma, cataracts that prohibit imaging, or any other eye pathology that in the opinion of the investigator would preclude enrollment)
CAI Sub-study:
Already being treated with CAIs
Previous documented failure to respond to CAI treatment
Any drug-specific contraindication/precaution listed below (from www.micromedex.com):
Topical Eye Drop Dorzolamide Hydrochloride
Contraindications:
hypersensitivity to dorzolamide products, including sulfa allergies
Precautions:
dorzolamide is a sulfonamide that is absorbed systemically, sulfonamide hypersensitivity reactions may occur
angle-closure glaucoma
concomitant use of oral carbonic-anhydrase inhibitors
conjunctivitis and lid reactions reported with chronic administration
moderate to severe renal (CrCl less than 30 mL/min) or hepatic insufficiency
ocular infection or inflammation
recent ocular surgery
Topical Eye Drop Brinzolamide
Contraindications:
hypersensitivity to any component of the product, including sulfa allergies
Precautions:
concomitant use of oral carbonic anhydrase inhibitors is not recommended
contact lens use; remove contact lenses prior to administration, allow 15 minutes before reinsertion
hypersensitivity to sulfonamides; severe reaction may occur; discontinue if signs or symptoms appear
low corneal endothelial cell counts; increased risk of corneal edema
renal impairment, severe (CrCl less than 30 mL/min); use not recommended
Clareo Health | Clinical Evaluation of Patients With X-linked Retinoschisis
