Natural History of the Progression of Choroideremia Study (NIGHT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03359551|
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : January 27, 2021
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||319 participants|
|Official Title:||Natural History of the Progression of Choroideremia Study|
|Actual Study Start Date :||June 30, 2015|
|Actual Primary Completion Date :||October 1, 2020|
|Actual Study Completion Date :||October 1, 2020|
- Change in Best-Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (EDTRS) [ Time Frame: Up to Month 20 ]BCVA will be assessed for both eyes using the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart. BCVA test should be performed prior to pupil dilation, and distance refraction should be carried out before BCVA is measured. Initially, letters are read at a distance of 4 meters from the chart. If <20 letters are read at 4 meters, testing at 1 meter should be performed. BCVA is to be reported as number of letters read correctly by the participant using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
- Change from Baseline in Reading Performance using International Reading Speed Texts (IReST) [ Time Frame: Baseline up to Month 12 ]Reading performance will be evaluated prior to pupil dilation.
- Change from Baseline in Color Vision [ Time Frame: Baseline up to Month 12 ]Colour vision will be tested prior to pupil dilation. Each eye will be tested separately and in the same order.
- Change from Baseline in Visual Fields [ Time Frame: Baseline up to Month 12 ]The progression of defects in visual fields will be assessed in both eyes using perimetry equipment.
- Change from Baseline in Contrast Sensitivity [ Time Frame: Baseline up to Month 12 ]Contrast sensitivity will be measured for both eyes, prior to pupil dilation, using a Pelli Robson chart.
- Change from Baseline in Retinal Thinning Using Spectral Domain Optical Coherence Tomography (SD-OCT) [ Time Frame: Baseline up to Month 20 ]SD-OCT measurements will be performed after dilation of the participant's pupil.
- Change from Baseline in Area of Viable Retinal Tissue Using Fundus Autofluorescence [ Time Frame: Baseline up to Month 20 ]Fundus Autofluorescence will be performed after dilation of the participant's pupil to assess changes in the area of viable retinal tissue.
- Change from Baseline in Retinal Sensitivity Using Microperimetry [ Time Frame: Baseline up to Month 20 ]Macular analyser integrity assessment (MAIA) microperimetry will be conducted for both eyes to assess changes in retinal sensitivity within the macula.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359551
|United States, California|
|Los Angeles, California, United States, 90095|
|United States, Florida|
|Miami, Florida, United States, 33136|
|United States, Maryland|
|Baltimore, Maryland, United States, 21287|
|United States, New York|
|New York, New York, United States, 10032|
|United States, Oregon|
|Portland, Oregon, United States, 97232|
|United States, Texas|
|Dallas, Texas, United States, 75231|
|United States, Wisconsin|
|Madison, Wisconsin, United States, 53705|
|São Paulo, Brazil, 04552-050|
|Edmonton, Alberta, Canada|
|Montréal, Canada, H3A 0E7|
|Vancouver, Canada, V5Z 3N9|
|Helsinki, Finland, 00290|
|Montpellier, France, 74103|
|Bonn, Germany, 53127|
|London, United Kingdom, EC1V 2PD|
|Manchester, United Kingdom, M13 9WL|
|Oxford, United Kingdom, OX3 9DU|
|Study Director:||Medical Director||Biogen|