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Safety Study to Evaluate Bilateral CNTF Implants in Subjects With MacTel 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04729972
Recruitment Status : Not yet recruiting
First Posted : January 29, 2021
Last Update Posted : February 2, 2021
Sponsor:
Collaborators:
The Lowy Medical Research Institute Limited
The Emmes Company, LLC
Information provided by (Responsible Party):
Neurotech Pharmaceuticals

Study Description
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Brief Summary:
This is a multi-center, open-label, 6-month study to evaluate the safety of bilateral CNTF implants in participants with Macular Telangiectasia Type 2.

Condition or disease Intervention/treatment Phase
Macular Telangiectasia Type 2 Combination Product: NT-501 CNTF implant Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Multicenter, Open-label Safety Study of Bilateral NT-501 in Participants With Macular Telangiectasia Type 2
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: NT-501 CNTF Implant
Participants from the NTMT-01 or NTMT-02 Studies with a CNFT implant in one eye will receive an implant in the fellow eye
 Combination Product: NT-501 CNTF implant
Single implantation of CNTF-secreting NT-501 device into one eye


Outcome Measures
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Primary Outcome Measures :
  1. Ocular and Systemic Safety [ Time Frame: 6 months ]
    The number and severity of adverse events , systemic and ocular ,from baseline through six months post-implantation.


Secondary Outcome Measures :
  1. Best correct visual acuity [ Time Frame: 6 months ]
    Changes in visual acuity and retinal imaging with optical coherence tomography (OCT).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must understand and sign the informed consent
  • Must be medically able to undergo ophthalmic surgery for the NT-501 device insertion and able to complete all required study procedures and visits
  • Participant must have received a NT-501 implant in one eye and have completed either the multicenter Phase 1 or Phase 2 study of NT-501 in subjects with MacTel
  • In the eye that does not have a NT-501 implant, participant must have a positive diagnosis of macular telangiectasia, type 2
  • Participant must have steady fixation in the foveal or parafoveal area and sufficiently clear media for good quality photographs

Exclusion Criteria:

  • Pregnant (positive pregnancy test at Visit 1 or intend to become pregnant during the study)
  • Nursing (lactating)
  • Participant has evidence of ocular disorder(s) in the study eye of a severity that could confound the interpretation of study results
  • Participant has a history or evidence of the following surgeries/procedures in the study eye, as assessed at Visit 1, including: Submacular surgery, Vitrectomy, Retinal detachment, Incisional glaucoma surgery, Trabeculectomy or trabeculoplasty, Cataract surgery or laser-assisted in situ keratomileusis (LASIK) performed in the previous 6 months
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): NCT04729972


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Neurotech Pharmaceuticals
The Lowy Medical Research Institute Limited
The Emmes Company, LLC
More Information
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Publications of Results:

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Responsible Party: Neurotech Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04729972    
Other Study ID Numbers: NTMT-02-B
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021

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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:
Macular Telangiectasia Type 2
CNTF
Mactel
Additional relevant MeSH terms:
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Telangiectasis
Vascular Diseases
Cardiovascular Diseases