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Ciliary Neurotrophic Factor (CNTF) Safety Trial in Patients With Macular Telangiectasia (Mactel)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01327911
First Posted: April 4, 2011
Last Update Posted: November 22, 2016
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.
Collaborator:
The Lowy Medical Research Institute Limited
Information provided by (Responsible Party):
Neurotech Pharmaceuticals
  Purpose
This study is a phase 1, open label, non-randomized, multi-center, pilot study to evaluate the safety and tolerability of NT-501 implants in 5-7 study participants with Mactel.

Condition Intervention Phase
Idiopathic Juxtafoveal Telangiectasia Biological: NT-501 implant Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients With Macular Telangiectasia Type 2 (Mactel)

Resource links provided by NLM:


Further study details as provided by Neurotech Pharmaceuticals:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 3,12, 24 and 36 months ]
    Visual acuity decrease of >=15 letters


Secondary Outcome Measures:
  • Microperimetry [ Time Frame: 12, 24 and 36 months ]
    Change of a 10dB at least one point either adjacent to a pre-existing scotoma or in a new area within the central 10 degrees on microperimetric testing

  • OCT [ Time Frame: 12, 24, and 36 months ]
    Change in en face area as measured by OCT


Enrollment: 7
Study Start Date: May 2011
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ciliary Neurotrophic Factor (CNTF)/NT-501
Biological/Vaccine:NT-501 implant
Biological: NT-501 implant
Ciliary neurotrophic factor (CNTF) implant

Detailed Description:
Protocol for Extended Follow-up of a Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients with Macular Telangiectasia Type 2 (MacTel)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participant must be offered sufficient opportunity to review the informed consent form, agree to the form's contents and sign the protocol's informed consent;
  • The participant must have bilateral MacTel;
  • Women of childbearing potential and all men must agree to use an effective form of birth control during the study;
  • Participant must be medically able to undergo ophthalmic surgery for ECT implant;
  • The participant's best-corrected visual acuity 64 letters or better (20/50 or better) in the study eye;

Exclusion Criteria:

  • Participant is < 21 years of age;
  • Participant is medically unable to comply with study procedures or follow- up visits;
  • Participant has evidence of ocular disease other than MacTel that may confound the outcome of the study (e.g., diabetic retinopathy with manifest macular edema, uveitis, etc.);
  • Participant has a chronic requirement (e.g., ≥ 4 weeks at a time) for ocular medications and/or has a diagnosed disease, that in the judgment of the examining physician, may be vision threatening or may affect the primary outcome (artificial tears are permitted);
  • Participant has evidence of subretinal neovascularization in either eye;
  • Participant has evidence of central serous chorio-retinopathy (CSR) in either eye;
  • Participant has evidence of pathologic myopia in either eye;
  • Participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy or trabeculoplasty;
  Contacts and Locations
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): NCT01327911


Locations
United States, California
Jules Stein Eye Institute
Los Angeles, California, United States, 90095
United States, Ohio
Retina Associates of Cleveland
Cleveland, Ohio, United States, 44122
Sponsors and Collaborators
Neurotech Pharmaceuticals
The Lowy Medical Research Institute Limited
Investigators
Study Chair: Weng Tao Neurotech USA
  More Information

Responsible Party: Neurotech Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01327911     History of Changes
Other Study ID Numbers: NTMT-01
First Submitted: March 30, 2011
First Posted: April 4, 2011
Last Update Posted: November 22, 2016
Last Verified: November 2016

Keywords provided by Neurotech Pharmaceuticals:
Mactel
Macular Telangiectasia Type 2

Additional relevant MeSH terms:
Telangiectasis
Vascular Diseases
Cardiovascular Diseases