Trial · NCT03071965
Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
NCT03071965, Phase 2, Completed, Neurotech Pharmaceuticals; results first posted 2025-05-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel). Trials, record NCT03071965. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03071965
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
- NCT number
- NCT03071965
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- Neurotech Pharmaceuticals
- Conditions
- MacTel (Macular Telangiectasia) Type 2
- Interventions
- Ciliary neurotrophic factor (CNTF), Surgery, Surgery
- First posted
- 2017-03-07
- Last updated
- 2025-05-09
- Results first posted
- 2025-05-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 |
| Primary | 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 | 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. |
| Secondary | 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) |
| Secondary | 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 |
| Secondary | 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 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | 72, 84, 96, and 108 months (based on participants' original implant date during precursor study) | All enrolled participants by eye | mm2 | MEAN |
| PRIMARY | 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) | Intent to treat population by eye | mm2 | MEAN |
| SECONDARY | Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only | Baseline to 72 Months (based on participants' original implant date) | Intent to Treat population by eye | dB | MEAN |
| SECONDARY | Change in BCVA From Baseline for Cohort 1 | Baseline to 108 Months (based on participants' original implant date) | Intent to Treat population by eye | letters | MEAN |
| SECONDARY | Change in BCVA From Baseline for Cohort 2 | Baseline to 72 Months (based on participants' original implant date) | Intent to Treat population by eye | letters | MEAN |
| SECONDARY | Change in Reading Speed From Baseline - Cohort 2 Only | Baseline to 72 Months (based on participants' original implant date) | Intent to Treat population by eye and based on participants who completed the reading speed assessment each timepoint | words per minute | MEAN |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | Cohort 1 - Fellow Eye | Baseline | 0.697 | Standard Deviation 0.8334 | mm2 |
| Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | Cohort 1 - NT-501 Implant | Baseline | 0.629 | Standard Deviation 0.08135 | mm2 |
| Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | Cohort 1 - Fellow Eye | 72 Months Post-Surgery Actual | 1.37 | Standard Deviation 1.4648 | mm2 |
| Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | Cohort 1 - NT-501 Implant | 72 Months Post-Surgery Actual | 1.137 | Standard Deviation 1.2905 | mm2 |
| Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | Cohort 1 - Fellow Eye | 72 Months Post-Surgery Change from Baseline | 0.620 | Standard Deviation 0.7526 | mm2 |
| Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | Cohort 1 - NT-501 Implant | 72 Months Post-Surgery Change from Baseline | 0.508 | Standard Deviation 0.6348 | mm2 |
| Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | Cohort 1 - Fellow Eye | 84 Months Post-Surgery Actual | 1.241 | Standard Deviation 1.4691 | mm2 |
| Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | Cohort 1 - NT-501 Implant | 84 Months Post-Surgery Actual | 1.132 | Standard Deviation 1.1194 | mm2 |
| Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | Cohort 1 - Fellow Eye | 84 Months Post-Surgery Change from Baseline | 0.705 | Standard Deviation 0.7474 | mm2 |
| Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1 | Cohort 1 - NT-501 Implant | 84 Months Post-Surgery Change from Baseline | 0.503 | Standard Deviation 0.5001 | mm2 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 - Implant Only | 6 | 6 |
| Overall Study | STARTED | Cohort 2 - Sham Only | 19 | 19 |
| Overall Study | STARTED | Cohort 2 - NT-501 Implant | 15 | 15 |
| Overall Study | STARTED | Cohort 2 - Sham + NT-501 Implant | 30 | 60 |
| Overall Study | Switched to NT-501 | Cohort 1 - Implant Only | 0 | 0 |
| Overall Study | Switched to NT-501 | Cohort 2 - Sham Only | 16 | 16 |
| Overall Study | Switched to NT-501 | Cohort 2 - NT-501 Implant | 0 | 0 |
| Overall Study | Switched to NT-501 | Cohort 2 - Sham + NT-501 Implant | 0 | 0 |
| Overall Study | Retained NT-501 Throughout the Study | Cohort 1 - Implant Only | 6 | 0 |
| Overall Study | Retained NT-501 Throughout the Study | Cohort 2 - Sham Only | 16 | 16 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events624
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cataract | Eye disorders | Cohort 1 - Implant Only | 0 | 6 | 0 |
| other | Cataract | Eye disorders | Cohort 2 - Sham Only | 4 | 19 | 4 |
| other | Cataract | Eye disorders | Cohort 2 - NT-501 Implant | 2 | 15 | 2 |
| other | Cataract | Eye disorders | Cohort 2 - Sham + NT-501 Implant | 0 | 30 | 0 |
| other | Delayed dark adaptation | Eye disorders | Cohort 1 - Implant Only | 0 | 6 | 0 |
| other | Delayed dark adaptation | Eye disorders | Cohort 2 - Sham Only | 3 | 19 | 3 |
| other | Delayed dark adaptation | Eye disorders | Cohort 2 - NT-501 Implant | 0 | 15 | 0 |
| other | Delayed dark adaptation | Eye disorders | Cohort 2 - Sham + NT-501 Implant | 0 | 30 | 0 |
| other | Eye pain | Eye disorders | Cohort 1 - Implant Only | 0 | 6 | 0 |
| other | Eye pain | Eye disorders | Cohort 2 - Sham Only | 3 | 19 | 3 |
1 to 10 of 624Source ClinicalTrials.gov
See all 624 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 - Implant Only | 0 | 6 |
| Total, all-cause mortality | Cohort 2 - Sham Only | 0 | 19 |
| Total, all-cause mortality | Cohort 2 - NT-501 Implant | 1 | 15 |
| Total, all-cause mortality | Cohort 2 - Sham + NT-501 Implant | 1 | 30 |
| Total, other adverse events | Cohort 1 - Implant Only | 6 | 6 |
| Total, other adverse events | Cohort 2 - Sham Only | 18 | 19 |
| Total, other adverse events | Cohort 2 - NT-501 Implant | 14 | 15 |
| Total, other adverse events | Cohort 2 - Sham + NT-501 Implant | 20 | 30 |
| Total, serious adverse events | Cohort 1 - Implant Only | 2 | 6 |
| Total, serious adverse events | Cohort 2 - Sham Only | 3 | 19 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03071965
GET https://conductscience.org/api/trials/v1/NCT03071965/results?page=2