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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Lowy Medical Research Institute Limited
Information provided by (Responsible Party):
Neurotech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01327911
First received: March 30, 2011
Last updated: July 1, 2013
Last verified: July 2013
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    Visual acuity decrease of >=15 letters


Secondary Outcome Measures:
  • Microperimetry [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in en face area as measured by OCT


Enrollment: 7
Study Start Date: May 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ciliary Neurotrophic Factor (CNTF)/NT-501 Biological: NT-501 implant
Ciliary neurotrophic factor (CNTF) implant

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Neurotech Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01327911     History of Changes
Other Study ID Numbers: NTMT-01
Study First Received: March 30, 2011
Last Updated: July 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Neurotech Pharmaceuticals:
Mactel
Macular Telangiectasia Type 2

Additional relevant MeSH terms:
Telangiectasis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014