Clinical trial NCT03071965: Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
Official title: Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: MacTel (Macular Telangiectasia) Type 2
Lead sponsor: Neurotech Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-03-07
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* There are no Exclusion Criteria

Primary outcomes:
measure: Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1
timeFrame: 72, 84, 96, and 108 months (based on participants' original implant date during precursor study)
measure: Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2
timeFrame: Baseline to 36, 48, 60 and 72 Months post-surgery (based on participants' original implant date during precursor study)
Secondary outcomes:
measure: Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only
timeFrame: Baseline to 72 Months (based on participants' original implant date)
measure: Change in BCVA From Baseline for Cohort 1
timeFrame: Baseline to 108 Months (based on participants' original implant date)
measure: Change in BCVA From Baseline for Cohort 2
timeFrame: Baseline to 72 Months (based on participants' original implant date)
measure: Change in Reading Speed From Baseline - Cohort 2 Only
timeFrame: Baseline to 72 Months (based on participants' original implant date)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Stein Eye Institute / David Geffen School of Medicine
state: California
city: Miami
country: United States
facility: University of Miami-Miller School of Medicine, Bascom Palmer Eye Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine, Dept of Ophthalmology, Emory University Eye Center
state: Georgia
city: Rockville
country: United States
facility: NIH Clinical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan, Kellogg Eye Center
state: Michigan
city: Cleveland
country: United States
facility: Retina Associates of Cleveland, Inc
state: Ohio
city: Madison
country: United States
facility: University of Wisconsin-Madison, Department of Ophthalmology and Visual Sciences
state: Wisconsin
city: Sydney
country: Australia
facility: Sydney Eye Hospital
state: New South Wales
city: East Melbourne
country: Australia
facility: Centre for Eye Research Australia
state: Victoria
city: Nedlands
country: Australia
facility: Lions Eye Institute
state: Western Australia
Study officials:
affiliation: Neurotech Pharmaceuticals, LLC
name: Thomas Aaberg, Jr, MD
role: STUDY_CHAIR
References: