Ciliary Neurotrophic Factor (CNTF) Safety Trial in Patients With Macular Telangiectasia (Mactel)
Primary Purpose
Idiopathic Juxtafoveal Telangiectasia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NT-501 implant
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Juxtafoveal Telangiectasia focused on measuring Mactel, Macular Telangiectasia Type 2
Eligibility 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;
Sites / Locations
- Jules Stein Eye Institute
- Retina Associates of Cleveland
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ciliary Neurotrophic Factor (CNTF)/NT-501
Arm Description
Biological/Vaccine:NT-501 implant
Outcomes
Primary Outcome Measures
Visual Acuity
Visual acuity decrease of >=15 letters
Secondary Outcome Measures
Microperimetry
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
Change in en face area as measured by OCT
Full Information
NCT ID
NCT01327911
First Posted
March 30, 2011
Last Updated
November 21, 2016
Sponsor
Neurotech Pharmaceuticals
Collaborators
The Lowy Medical Research Institute Limited
1. Study Identification
Unique Protocol Identification Number
NCT01327911
Brief Title
Ciliary Neurotrophic Factor (CNTF) Safety Trial in Patients With Macular Telangiectasia (Mactel)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurotech Pharmaceuticals
Collaborators
The Lowy Medical Research Institute Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Juxtafoveal Telangiectasia
Keywords
Mactel, Macular Telangiectasia Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ciliary Neurotrophic Factor (CNTF)/NT-501
Arm Type
Experimental
Arm Description
Biological/Vaccine:NT-501 implant
Intervention Type
Biological
Intervention Name(s)
NT-501 implant
Intervention Description
Ciliary neurotrophic factor (CNTF) implant
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Visual acuity decrease of >=15 letters
Time Frame
3,12, 24 and 36 months
Secondary Outcome Measure Information:
Title
Microperimetry
Description
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
Time Frame
12, 24 and 36 months
Title
OCT
Description
Change in en face area as measured by OCT
Time Frame
12, 24, and 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weng Tao
Organizational Affiliation
Neurotech USA
Official's Role
Study Chair
Facility Information:
Facility Name
Jules Stein Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Retina Associates of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ciliary Neurotrophic Factor (CNTF) Safety Trial in Patients With Macular Telangiectasia (Mactel)
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