Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
- Conditions
- MacTel (Macular Telangiectasia) Type 2
- Interventions
- Biological: Ciliary neurotrophic factor (CNTF)Procedure: Surgery
- Registration Number
- NCT03071965
- Lead Sponsor
- Neurotech Pharmaceuticals
- Brief Summary
This was a prospective, multicenter, single-masked, sham-controlled extension study designed to provide long-term safety and efficacy follow-up data for subjects with MacTel who had NT-501 implanted intraocularly and/or underwent sham surgery in the respective precursor study (NTMT-01 or NTMT-02).
A substudy was conducted in which subjects enrolled in study (NTMT-02), who had 1 study-eligible eye that underwent sham surgery, were offered the option to have NT-501 implanted in the same study eye. Of the 19 subjects who had 1 study-eligible eye and underwent sham surgery in the Cohort 2 precursor study (NTMT-02), 16 subjects elected to have NT-501 implanted in the same study eye during the substudy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Previously enrolled in the NTMT-01 or NTMT-02 protocol and received the NT-501 implant and/or underwent a Sham procedure
- Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form's contents, and provide written informed consent.
- There are no Exclusion Criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 Ciliary neurotrophic factor (CNTF) Participants completed protocol NTMT-02. Participants received surgery to implant NT-501 or sham surgery to mimic implant procedure. Participants that received NT-501 implant were exposed to ciliary neurotrophic factor (CNTF). Cohort 1 Surgery Participants completed protocol NTMT-01. All participants received surgery to implant NT-501. All participants received ciliary neurotrophic factor (CNTF). Cohort 2 Surgery Participants completed protocol NTMT-02. Participants received surgery to implant NT-501 or sham surgery to mimic implant procedure. Participants that received NT-501 implant were exposed to ciliary neurotrophic factor (CNTF). Cohort 1 Ciliary neurotrophic factor (CNTF) Participants completed protocol NTMT-01. All participants received surgery to implant NT-501. All participants received ciliary neurotrophic factor (CNTF). Cohort 1 Ciliary neurotrophic factor (CNTF) Participants completed protocol NTMT-01. All participants received surgery to implant NT-501. All participants received ciliary neurotrophic factor (CNTF). Cohort 1 Surgery Participants completed protocol NTMT-01. All participants received surgery to implant NT-501. All participants received ciliary neurotrophic factor (CNTF). Cohort 2 Ciliary neurotrophic factor (CNTF) Participants completed protocol NTMT-02. Participants for cohort 2 arm were either: * NT-501 group: included subjects who each had 1 study-eligible eye that had NT-501 implanted and a fellow eye that did not undergo any study intervention. * Sham group: included subjects who each had 1 study-eligible eye that underwent sham surgery and a fellow eye that did not undergo any study intervention. * Sham+NT-501 group: included subjects who had both eyes that were study-eligible, and had NT-501 implanted in 1 eye and underwent sham surgery in the contralateral eye. Cohort 2 Surgery Participants completed protocol NTMT-02. Participants for cohort 2 arm were either: * NT-501 group: included subjects who each had 1 study-eligible eye that had NT-501 implanted and a fellow eye that did not undergo any study intervention. * Sham group: included subjects who each had 1 study-eligible eye that underwent sham surgery and a fellow eye that did not undergo any study intervention. * Sham+NT-501 group: included subjects who had both eyes that were study-eligible, and had NT-501 implanted in 1 eye and underwent sham surgery in the contralateral eye.
- Primary Outcome Measures
Name Time Method Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 72, 84, 96, and 108 months (based on participants' original implant date during precursor study) Change from baseline to 72, 84, 96 and 108 months post-surgery (based on participants' original implant date during precursor study) by SD-OCT for Cohort 1
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2 Baseline to 36, 48, 60 and 72 Months post-surgery (based on participants' original implant date during precursor study) Change in EZ from baseline to 36, 48, 60 and 72 Months post-surgery (based on participants' original implant date during precursor study). Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up
- Secondary Outcome Measures
Name Time Method Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only Baseline to 72 Months (based on participants' original implant date) Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months post-surgery (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up in this study.
Change in Reading Speed From Baseline - Cohort 2 Only Baseline to 72 Months (based on participants' original implant date) Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up. Note: there were
Change in BCVA From Baseline for Cohort 2 Baseline to 72 Months (based on participants' original implant date) Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up
Change in BCVA From Baseline for Cohort 1 Baseline to 108 Months (based on participants' original implant date) Baseline to 108 Months - analyses also presented for additional times: 84, 96 and 108 Months (based on participants' original implant date)
Trial Locations
- Locations (11)
Stein Eye Institute / David Geffen School of Medicine
🇺🇸Los Angeles, California, United States
Emory University School of Medicine, Dept of Ophthalmology, Emory University Eye Center
🇺🇸Atlanta, Georgia, United States
University of Miami-Miller School of Medicine, Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
Massachusetts Eye and Ear Infirmary
🇺🇸Boston, Massachusetts, United States
Retina Associates of Cleveland, Inc
🇺🇸Cleveland, Ohio, United States
Lions Eye Institute
🇦🇺Nedlands, Western Australia, Australia
University of Wisconsin-Madison, Department of Ophthalmology and Visual Sciences
🇺🇸Madison, Wisconsin, United States
University of Michigan, Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States
NIH Clinical Center
🇺🇸Rockville, Maryland, United States
Sydney Eye Hospital
🇦🇺Sydney, New South Wales, Australia
Centre for Eye Research Australia
🇦🇺East Melbourne, Victoria, Australia