Safety Study to Evaluate Bilateral CNTF Implants in Subjects With MacTel Type 2
- Conditions
- Macular Telangiectasia Type 2
- Interventions
- Combination Product: NT-501 CNTF implant
- Registration Number
- NCT04729972
- Lead Sponsor
- Neurotech Pharmaceuticals
- Brief Summary
This is a multi-center, open-label, 6-month study to evaluate the safety of bilateral CNTF implants in participants with Macular Telangiectasia Type 2.
- Detailed Description
This was a multicenter, open-label study designed to evaluate the safety of bilateral NT-501 in subjects with MacTel. All subjects who received NT-501 in a single eye prior to or in the Phase 1/2 extension study (NTMT-01/02E) or in 1 of the 2 Phase 3 studies (NTMT-03-A or NTMT-03-B), and met all other eligibility criteria, qualified for participation in the current study; enrolled subjects underwent intraocular implantation of NT-501 in the fellow eye and were followed for 6 months. Note that, throughout this report, all references to "study eye" mean the eye that received NT-501 in the current study (ie, not the eye that was treated in the previous study).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NT-501 CNTF Implant NT-501 CNTF implant Participants from the NTMT-01/02 Extenstion study or participants from the NTMT-03 study which received an implant Studies with a CNFT implant in one eye will receive an implant in the fellow eye
- Primary Outcome Measures
Name Time Method Frequency of Ocular and/or Non-ocular Treatment Emergent Adverse Events 6 months Assess the incidence and severity of adverse events (AEs) following bilateral ocular implantation of NT-501
- Secondary Outcome Measures
Name Time Method Serum Levels of CNTF and Immunogenicity for NT-501 6 months Incidence of positive serum levels of CNTF and immunogenicity for NT-501 with quantification of antibodies (Ab) to CNTF, neutralizing antibodies (NAb) to CNTF, Ab to NTC-201-6A cells, and Ab to mouse dihydrofolate reductase (mDHFR) at any time.
Trial Locations
- Locations (10)
Massachusetts Eye and Ear Infirmary, Retina Service
🇺🇸Boston, Massachusetts, United States
Jules Stein Eye Institute
🇺🇸Los Angeles, California, United States
Lions Eye Institute
🇦🇺Nedlands, Western Australia, Australia
National Eye Institute
🇺🇸Washington, District of Columbia, United States
Bascom Palmer
🇺🇸Miami, Florida, United States
Retina Associates of Cleveland, Inc.
🇺🇸Beachwood, Ohio, United States
Retina Consultants of Texas
🇺🇸Houston, Texas, United States
Save Sight Institute
🇦🇺Sydney, New South Wales, Australia
University of Michigan, Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States
Centre for Eye Research Australia
🇦🇺East Melbourne, Victoria, Australia