A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol A
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|ClinicalTrials.gov Identifier: NCT03316300|
Recruitment Status : Active, not recruiting
First Posted : October 20, 2017
Last Update Posted : June 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Macular Telangiectasia Type 2||Combination Product: NT-501 Procedure: Sham||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2|
|Actual Study Start Date :||November 24, 2017|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||August 31, 2022|
Combination Product: NT-501
Surgery to receive one NT-501 device implant.
|Sham Comparator: Sham||
Non-penetrating sham procedure to mimic implant procedure.
- Rate of Change in Ellipsoid Zone (EZ) Area Loss [ Time Frame: Baseline through 24 months. ]Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence Tomography (SD-OCT) in the study eye.
- Mean Change in Aggregate Sensitivity of Microperimetry [ Time Frame: Baseline through 24 months. ]NT-501 compared to sham relative to mean change in aggregate sensitivity of microperimetry within the EZ line break area.
- Mean Change in Reading Speed [ Time Frame: Baseline through 24 months. ]NT-501 compared to sham relative to mean change in reading speed assessed using International Reading Speed Texts (IReST) cards.
- National Eye Institute-Visual Function Questionnaire (NEI-VFQ) [ Time Frame: Baseline through 24 months. ]NT-501 compared to sham relative to mean change in the NEI-VFQ near activities subscale score.
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): NCT03316300
|Principal Investigator:||Emily Chew, MD||National Eye Institute (NEI)|