Clinical Evaluation of Patients With X-linked Retinoschisis

Completed

Conditions studied: X-linked Retinoschisis, XLRS

In brief

The purpose of this study is to evaluate subjects with X-linked retinoschisis in a clinical setting to collect data on disease progression.

Key facts

Study ID

NCT02331173

Run by

Beacon Therapeutics

People needed

66

Starts

2012-11-01

Expected to finish

2016-10-01

Last updated by the study team

2017-11-17

Who can join

Age: 7 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify 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 qualify 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:
• Exclusion Criteria
• 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

Where it is running

• University of Michigan Kellogg Eye Center — Ann Arbor, Michigan, United States
• Casey Eye Institute, Oregon Health and Sciences University — Portland, Oregon, United States
• Retina Foundation of the Southwest — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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