We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2

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: NCT03319849
Recruitment Status : Completed
First Posted : October 24, 2017
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Neurotech Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 3, 2017
First Posted Date  ICMJE October 24, 2017
Last Update Posted Date February 8, 2023
Actual Study Start Date  ICMJE February 6, 2018
Actual Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2019)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2017)		 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2021)
  • 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 Internal 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2017)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2
Official Title  ICMJE A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2
Brief Summary This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the NT-501 implants in participants with macular telangiectasia type 2.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Macular Telangiectasia Type 2
Intervention  ICMJE
  • Combination Product: NT-501
    Surgery to receive one NT-501 device implant.
  • Procedure: Sham
    Non-penetrating sham procedure to mimic implant procedure.
Study Arms  ICMJE
  • Experimental: NT-501
    Intervention: Combination Product: NT-501
  • Sham Comparator: Sham
    Intervention: Procedure: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2022)		 113
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2017)		 112
Actual Study Completion Date  ICMJE September 23, 2022
Actual Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Participant must have at least one study eye with a positive diagnosis of MacTel Type 2
  • Participant must have an Inner Segment - Outer Segment Junction Line (IS/OS) Photo Receptor (PR) break in the study eye(s) and en face EZ (area of IS/OS loss) as measured by spectral-domain optical coherence tomography (SDOCT) between 0.16 mm^2 and 2.00 mm^2
  • Participant's best corrected visual acuity is 54 letter score or better (20/80 or better) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart

Key Exclusion Criteria:

  • Participant received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months
  • Participant has ever received intravitreal anti-vascular endothelial growth factor (VEGF) therapy in the study eye or has, within the past 3 months, received intravitreal anti-VEGF in the fellow eye
  • Participant has evidence of ocular disease other than MacTel that, in the judgment of the examining physician, may confound the diagnosis, procedures or outcome of the study
  • Participant was a study participant in any other clinical trial of an intervention (drug or device) within the last 6 months
  • Participant is pregnant or breastfeeding
  • Participant has a chronic requirement (eg ≥ 4 weeks at a time) for ocular medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03319849
Other Study ID Numbers  ICMJE NTMT-03-B
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Neurotech Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Neurotech Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emily Chew, MD National Eye Institute (NEI)
PRS Account Neurotech Pharmaceuticals
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP