NCT02331173|Completed
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Sponsor study identifier
observational
66
1 country
3
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2016
Actual (reported)Study Completion
October 2016
Actual (reported)The purpose of this study is to evaluate subjects with X-linked retinoschisis in a clinical setting to collect data on disease progression.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
December 8, 2014
Actual (reported)January 6, 2015
Actual (reported)October 2016
Actual (reported)October 2016
Actual (reported)Disease progression in subjects with XLRS
Every 6 months for 18 months
Disease progression using microperimetry, a non-standard of care visual function test
Every 6 months for 18 months
Disease progression using electroretinograms (ERGs), a non-standard of care visual function test
Every 6 months for 18 months
Disease progression using the reading speed test, a non-standard of care visual function test
Every 6 months for 18 months
Disease progression using the contrast sensitivity test, a non-standard of care visual function test
Every 6 months for 18 months
Disease progression using a quality of life questionnaire
Every 6 months for 18 months
All subjects enrolled in this study will be seen every 6 months following the screening visit. During the 3 main study visits, a series of tests will be performed to assess visual function. Some of these tests are part of routine care that patients would receive on an annual basis regardless of study participation. Other tests are being performed to determine if they are effective at monitoring disease progression in this population. For each of the 3 main study visits, testing may be spread over multiple days to ensure completion of all tests.
Subjects with maculoschisis may be offered topical treatment with CAIs. These subjects will be asked to visit the study site at 1 month and 3 months after starting topical treatment. During these additional visits, subjects will undergo a dilated eye exam, BCVA, and SD-OCT imaging to assess efficacy of treatment (i.e. reduction of maculoschisis).
Dosing of all medications will be based upon standard of care. Standard dosing for the treatment of pediatric and adult patients with XLRS is as follows: * Topical dorzolamide 2% three times per day * Topical brinzolamide 1% three times per day
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Dorzolamide 2% TID or brinzolamide 1% TID
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordPotential subjects will be identified from the Oregon Retinal Degeneration Center (ORDC) database and the Retina and Ophthalmic practices at Oregon Health and Science University Casey Eye Institute, Retina Foundation of the Southwest and Kellogg Eye Center.
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, 48105, United States
Casey Eye Institute, Oregon Health and Sciences University
Portland, Oregon, 97239, United States
Retina Foundation of the Southwest
Dallas, Texas, 75231, United States
Pennesi ME, Birch DG, Jayasundera KT, Parker M, Tan O, Gurses-Ozden R, Reichley C, Beasley KN, Yang P, Weleber RG, Bennett LD, Heckenlively JR, Kothapalli K, Chulay JD, For The Xlrs-Study Group. Prospective Evaluation of Patients With X-Linked Retinoschisis During 18 Months. Invest Ophthalmol Vis Sci. 2018 Dec 3;59(15):5941-5956. doi: 10.1167/iovs.18-24565.
Matt Feinsod, MD
Applied Genetics Technologies Corporation
66 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2014
First Posted
January 6, 2015
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2016
Actual (reported)Study Completion
October 2016
Actual (reported)Last Updated
November 17, 2017
Record last verified: 2017-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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