Phase 2
N=70
Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
MacTel (Macular Telangiectasia) Type 2
Bottom Line
View on ClinicalTrials.gov: NCT03071965 ↗Enrolled (actual)
70
Serious AEs
22.9%
Results posted
May 2025
Primary outcome: Primary: Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 — 0.697; 0.629; 1.37; 1.137 mm2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ciliary neurotrophic factor (CNTF) (Biological); Surgery (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Neurotech Pharmaceuticals
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 |
0.697; 0.629; 1.37; 1.137; 0.620; 0.508 | — |
| PRIMARY Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2 |
0.684; 0.766; 0.259; 0.279; 0.360; 0.282 | 0.5455 |
| SECONDARY Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only |
25.688; 25.672; -1.391; -1.054; -2.312; -1.965 | — |
| SECONDARY Change in BCVA From Baseline for Cohort 1 |
80.5; 75.0; 72.8; 71.8; -7.7; -3.2 | — |
| SECONDARY Change in BCVA From Baseline for Cohort 2 |
77.2; 77.0; -4.8; -3.2; -5.7; -3.9 | — |
| SECONDARY Change in Reading Speed From Baseline - Cohort 2 Only |
94.740; 107.222; -8.838; -17.798; -18.931; -25.488 | — |
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
Data sourced from ClinicalTrials.gov (NCT03071965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.