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

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ClinicalTrials.gov Identifier: NCT01327911
Recruitment Status : Completed
First Posted : April 4, 2011
Last Update Posted : November 22, 2016
Sponsor:
Collaborator:
The Lowy Medical Research Institute Limited
Information provided by (Responsible Party):
Neurotech Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 30, 2011
First Posted Date  ICMJE April 4, 2011
Last Update Posted Date November 22, 2016
Study Start Date  ICMJE May 2011
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
Visual Acuity [ Time Frame: 3,12, 24 and 36 months ]
Visual acuity decrease of >=15 letters
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2011)
  • ERG [ Time Frame: 3 and 12 months ]
    ≥ 30% reduction in ERG potentials
  • Visual Acuity [ Time Frame: 3 and 12 months ]
    Visual acuity decrease of >=15 letters
  • Rejection or extrusion of the NT-501 device [ Time Frame: 3 and 12 months ]
  • Abnormal laboratory findings [ Time Frame: 12 months ]
    Protocol-related abnormal findings from serum chemistry, hematology, and urinalysis/urine chemistry
  • Serum CNTF levels [ Time Frame: 12 months ]
    Serum CNTF levels and the circulating antibodies to CNTF and NTC-201
  • Peri-implant fibrosis [ Time Frame: 3 and 12 months ]
  • Development of choroidal neovascularization (CNV) [ Time Frame: 3 and 12 months ]
  • Adverse Events [ Time Frame: 3 and 12 months ]
    Adverse events affecting ocular function which are potentially related to the implant
  • Toxicities [ Time Frame: 3 and 12 months ]
    Local or systemic toxicities considered serious adverse events that are potentially related to the implant
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2011)
  • Visual Acuity [ Time Frame: 12 months ]
    Mean change in visual acuity
  • Microperimetry [ Time Frame: 12 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
  • Adaptive Optics [ Time Frame: 12 months ]
    Cone density as measured by adaptive optics (AOSLO), or development or progression of an area of loss of cones as measured by AOSLO
  • OCT [ Time Frame: 12 months ]
    Prevention of extension of the inner/outer segment break as shown on OCT
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ciliary Neurotrophic Factor (CNTF) Safety Trial in Patients With Macular Telangiectasia (Mactel)
Official Title  ICMJE A Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients With Macular Telangiectasia Type 2 (Mactel)
Brief Summary 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.
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Juxtafoveal Telangiectasia
Intervention  ICMJE Biological: NT-501 implant
Ciliary neurotrophic factor (CNTF) implant
Study Arms  ICMJE Experimental: Ciliary Neurotrophic Factor (CNTF)/NT-501
Biological/Vaccine:NT-501 implant
Intervention: Biological: NT-501 implant
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: April 1, 2011)
7
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01327911
Other Study ID Numbers  ICMJE NTMT-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neurotech Pharmaceuticals
Study Sponsor  ICMJE Neurotech Pharmaceuticals
Collaborators  ICMJE The Lowy Medical Research Institute Limited
Investigators  ICMJE
Study Chair: Weng Tao Neurotech USA
PRS Account Neurotech Pharmaceuticals
Verification Date November 2016

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