A Phase 2 interventional study of NT-501 CNTF implant in Macular Telangiectasia Type 2, sponsored by Neurotech Pharmaceuticals. Completed at 10 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by Neurotech Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
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).
General Inclusion Criteria
Ocular Inclusion Criteria
General Exclusion Criteria
Females of childbearing potential (those who are not surgically sterilized or post- menopausal, i.e., absence of menstruation for 12 months or longer) may not participate in the study if any of the following conditions exists:
Ocular Exclusion Criteria
Participant has a history or evidence of the following surgeries/procedures in the study eye, as assessed at Visit 1, including:
NT-501 was implanted on Day 0 in the fellow eye of subjects who received a single NT-501 in a previous study; subjects were followed for 6 months post-implantation of NT-501 in this study.
Combination Product: NT-501 CNTF implant
Single implantation of CNTF-secreting NT-501 device into fellow (untreated) eye
Frequency of Ocular and/or Non-ocular Treatment Emergent Adverse Events
Assess the incidence and severity of adverse events (AEs) following bilateral ocular implantation of NT-501
Time frame: 6 months
Serum Levels of CNTF and Immunogenicity for NT-501
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.
Time frame: 6 months
Of the 33 enrolled subjects, 32 (97.0%) received NT-501; the exception was a subject whose surgery was canceled due to an event of arterial fibrillation that occurred prior to surgery and resulted in subject discontinuation. No subject had NT-501 removed from either eye during the study, and all 32 subjects who received NT-501 in this study completed the study.
| Milestone | NT-501 in Fellow Eye |
|---|---|
| Started | 33 |
| Nt-501 implanted in study eye | 32 |
| Completed | 32 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
Assess the incidence and severity of adverse events (AEs) following bilateral ocular implantation of NT-501
| Participants | NT-501 in Fellow Eye |
|---|---|
| At least 1 TEAE | 26 |
| At least 1 ocular TEAE in study eye | 26 |
| At least 1 ocular TEAE in fellow eye | 6 |
| At least 1 nonocular TEAE | 13 |
| At least 1 treatment related ocular TEAE | 26 |
| At least 1 treatment related nonocular TEAE | 0 |
| At least 1 SAE | 2 |
| NT-501 removal from either eye | 0 |
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.
| Participants | NT-501 in Fellow Eye |
|---|---|
| CNTF Positive | 0 |
| Ab Positive to CNTF | 1 |
| Neutralizing Ab to CNTF | 0 |
| Ab to NTC | 0 |
| ab to DHRF | 0 |
Collected over Through 6 months post implant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NT-501 in Fellow Eye | 0/32 (0%) | 2/32 (6.3%) | 26/32 (81.3%) |
| Event | NT-501 in Fellow Eye |
|---|---|
| Device ExtrusionSurgical and medical procedures | 1/32 |
| Feces discoloredGastrointestinal disorders | 1/32 |
| Event | NT-501 in Fellow Eye |
|---|---|
| Eye painEye disorders | 9/32 |
| Ocular discomfortEye disorders | 9/32 |
| Conjunctival haemorrhageEye disorders | 8/32 |
| Eye irritationEye disorders | 4/32 |
| Dry eyeEye disorders | 2/32 |
| Anterior chamber cellEye disorders | 1/32 |
| Anterior chamber flareEye disorders | 1/32 |
| CataractEye disorders | 1/32 |
| Cataract subcapsularEye disorders | 1/32 |
| Conjunctival hyperaemiaEye disorders | 1/32 |
Baseline demographics and characteristics are based on total number of participants who completed NT-501 implant in study eye
| Age, Customized(years) | NT-501 in Fellow Eye |
|---|---|
| Age (Years) | 63.0 ± 6.55 |
| Age, Customized(Participants) | NT-501 in Fellow Eye |
|---|---|
| 50 to < 60 years | 9 |
| 60 to < 70 years | 17 |
| > or = to 70 years | 6 |
| Sex: Female, Male(Participants) | NT-501 in Fellow Eye |
|---|---|
| Female | 24 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | NT-501 in Fellow Eye |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 30 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | NT-501 in Fellow Eye |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 28 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| BCVA (letters) for Study Eye(letters correctly read) | NT-501 in Fellow Eye |
|---|---|
| Study Eye | 68.7 ± 11.01 |
| Fellow Eye | 70.1 ± 9.58 |
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Neurotech Pharmaceuticals