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

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: NCT03316300
Recruitment Status : Completed
First Posted : October 20, 2017
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Neurotech Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Macular Telangiectasia Type 2 Combination Product: NT-501 Procedure: Sham Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Primary Completion Date : August 31, 2022
Actual Study Completion Date : September 23, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: NT-501 Combination Product: NT-501
Surgery to receive one NT-501 device implant.
Sham Comparator: Sham Procedure: Sham
Non-penetrating sham procedure to mimic implant procedure.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Neurotech Pharmaceuticals
Investigators
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Principal Investigator: Emily Chew, MD National Eye Institute (NEI)
More Information
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Responsible Party: Neurotech Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03316300    
Other Study ID Numbers: NTMT-03-A
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Neurotech Pharmaceuticals:
Ciliary Neurotrophic Factor (CNTF)
Macular Telangiectasia (MacTel)
Additional relevant MeSH terms:
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Telangiectasis
Vascular Diseases
Cardiovascular Diseases