A Study to Determine the Safety and Efficacy of Renexus® in Macular Telangiectasia Type 2
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|ClinicalTrials.gov Identifier: NCT03319849|
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : March 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Macular Telangiectasia Type 2||Combination Product: Renexus® 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 Renexus® in Macular Telangiectasia Type 2|
|Actual Study Start Date :||February 6, 2018|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
Combination Product: Renexus®
Surgery to receive one Renexus® device implant.
|Sham Comparator: Sham||
Non-penetrating sham procedure to mimic implant procedure.
- Mean Change in Ellipsoid Zone (EZ) [ Time Frame: Baseline through 24 months. ]Mean change in EZ as measured by en face imaging by Spectral-Domain Optical Coherence Tomography (SD-OCT) in the study eye.
- Central Macular Thickness [ Time Frame: Baseline through 24 months. ]Renexus® compared to sham relative to mean change in central macular thickness.
- Proportion of Eyes with >35% Increase in EZ Break Area [ Time Frame: From baseline at month 24. ]Renexus ® compared to sham relative to proportion of eyes with >35% increase in EZ break area.
- Mean Change in Aggregate Sensitivity of Microperimetry [ Time Frame: Baseline through 24 months. ]Renexus ® 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. ]Renexus® compared to sham relative to mean change in reading speed assessed using Internal Reading Speed Texts (IReST) cards.
- National Eye Institute-Visual Function Questionnaire (NEI-VFQ) [ Time Frame: Baseline through 24 months. ]Renexus® 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): NCT03319849
|Contact: Kenneth J. Mandell, MD, PhDfirstname.lastname@example.org|
Show 20 Study Locations
|Study Chair:||Kenneth J. Mandell, MD, PhD||Neurotech Pharmaceuticals, Inc.|