Trial · NCT03319849
A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol B
NCT03319849, Phase 3, Completed, Neurotech Pharmaceuticals; results first posted 2024-09-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol B. Trials, record NCT03319849. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03319849
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol B
- NCT number
- NCT03319849
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 119 participants, actual
- Lead sponsor
- Neurotech Pharmaceuticals
- Conditions
- Macular Telangiectasia Type 2
- Interventions
- NT-501, Sham
- First posted
- 2017-10-24
- Last updated
- 2024-09-24
- Results first posted
- 2024-09-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Rate of Change in the Area of EZ Area of Loss From Baseline Through Month 24 | End point timeframe is through Month 24. Baseline, Month 6, 12, 16, 20 and 24. Month 6 was collected but not included in the primary analyses. | The rate of change in the area of EZ loss (IS/OS; macular photoreceptor loss) from baseline through month 24, as assessed using SD-OCT in the study eye of participants with MacTel. |
| Secondary | Mean Change in Aggregate Retinal Sensitivity Loss and Aggregate Interpolated Retinal Sensitivity Loss by Microperimetry (mITT Population) | Baseline through 24 months. | Change from baseline in retinal sensitivity loss as measured by as measured by Macular Integrity Assessment (MAIA) |
| Secondary | Monocular Reading Speed (mITT Population) | Baseline through 24 months. | Change from baseline through Month 24 for Monocular reading speed assessed using International Reading Speed Texts (IReST) cards developed by the IReST Study Group 21 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Rate of Change in the Area of EZ Area of Loss From Baseline Through Month 24 | End point timeframe is through Month 24. Baseline, Month 6, 12, 16, 20 and 24. Month 6 was collected but not included in the primary analyses. | The efficacy and safety of the NT-501 implant that delivers a daily dose of CNTF in comparison to sham surgery with no implant, in participants with confirmed MacTel. | mm^2 | MEAN |
| SECONDARY | Mean Change in Aggregate Retinal Sensitivity Loss and Aggregate Interpolated Retinal Sensitivity Loss by Microperimetry (mITT Population) | Baseline through 24 months. | All treated participants (mITT population) | dB | MEAN |
| SECONDARY | Monocular Reading Speed (mITT Population) | Baseline through 24 months. | All treated participants (mITT population) without missing data | Reading Speed (words per minute) | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Rate of Change in the Area of EZ Area of Loss From Baseline Through Month 24 | NT-501 | 0.111 | Standard Error 0.0142 | mm^2 | |
| The Rate of Change in the Area of EZ Area of Loss From Baseline Through Month 24 | Sham | 0.160 | Standard Error 0.0149 | mm^2 | |
| Mean Change in Aggregate Retinal Sensitivity Loss and Aggregate Interpolated Retinal Sensitivity Loss by Microperimetry (mITT Population) | Aggregate Retinal Sensitivity Loss (dB) - NT-501 | Baseline Actual | 55.54 | Standard Deviation 56.050 | dB |
| Mean Change in Aggregate Retinal Sensitivity Loss and Aggregate Interpolated Retinal Sensitivity Loss by Microperimetry (mITT Population) | Aggregate Retinal Sensitivity Loss (dB) - Sham | Baseline Actual | 51.84 | Standard Deviation 57.380 | dB |
| Mean Change in Aggregate Retinal Sensitivity Loss and Aggregate Interpolated Retinal Sensitivity Loss by Microperimetry (mITT Population) | Aggregate Interpolated Retinal Sensitivity Loss (dB) - NT-501 | Baseline Actual | 34864.17 | Standard Deviation 35305.260 | dB |
| Mean Change in Aggregate Retinal Sensitivity Loss and Aggregate Interpolated Retinal Sensitivity Loss by Microperimetry (mITT Population) | Aggregate Interpolated Retinal Sensitivity Loss (dB) - Sham | Baseline Actual | 32445.03 | Standard Deviation 38667.790 | dB |
| Mean Change in Aggregate Retinal Sensitivity Loss and Aggregate Interpolated Retinal Sensitivity Loss by Microperimetry (mITT Population) | Aggregate Retinal Sensitivity Loss (dB) - NT-501 | Month 24 Actual | 97.77 | Standard Deviation 78.620 | dB |
| Mean Change in Aggregate Retinal Sensitivity Loss and Aggregate Interpolated Retinal Sensitivity Loss by Microperimetry (mITT Population) | Aggregate Retinal Sensitivity Loss (dB) - Sham | Month 24 Actual | 93.02 | Standard Deviation 70.414 | dB |
| Mean Change in Aggregate Retinal Sensitivity Loss and Aggregate Interpolated Retinal Sensitivity Loss by Microperimetry (mITT Population) | Aggregate Interpolated Retinal Sensitivity Loss (dB) - NT-501 | Month 24 Actual | 61076.49 | Standard Deviation 52619.379 | dB |
| Mean Change in Aggregate Retinal Sensitivity Loss and Aggregate Interpolated Retinal Sensitivity Loss by Microperimetry (mITT Population) | Aggregate Interpolated Retinal Sensitivity Loss (dB) - Sham | Month 24 Actual | 58360.26 | Standard Deviation 50535.070 | dB |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NT-501 | 60 | 60 |
| Overall Study | STARTED | Sham | 59 | 59 |
| Overall Study | Treated (Underwent Surgery) | NT-501 | 59 | 59 |
| Overall Study | Treated (Underwent Surgery) | Sham | 54 | 54 |
| Overall Study | COMPLETED | NT-501 | 57 | 57 |
| Overall Study | COMPLETED | Sham | 49 | 49 |
| Overall Study | NOT COMPLETED | NT-501 | 3 | 3 |
| Overall Study | NOT COMPLETED | Sham | 10 | 10 |
Source ClinicalTrials.gov
Adverse events434
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 | Blepharal papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NT-501 | 1 | 59 | |
| other | Blepharal papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sham | 0 | 54 | |
| other | Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NT-501 | 1 | 59 | |
| other | Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sham | 1 | 54 | |
| other | Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NT-501 | 0 | 59 | |
| other | Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sham | 1 | 54 | |
| other | Hypertension | Vascular disorders | NT-501 | 4 | 59 | |
| other | Hypertension | Vascular disorders | Sham | 1 | 54 | |
| other | Hot flush | Vascular disorders | NT-501 | 0 | 59 | |
| other | Hot flush | Vascular disorders | Sham | 2 | 54 |
1 to 10 of 434Source ClinicalTrials.gov
See all 434 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NT-501 | 1 | 59 |
| Total, all-cause mortality | Sham | 0 | 54 |
| Total, other adverse events | NT-501 | 56 | 59 |
| Total, other adverse events | Sham | 48 | 54 |
| Total, serious adverse events | NT-501 | 11 | 59 |
| Total, serious adverse events | Sham | 10 | 54 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40693847 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NT-501 vs Sham: deaths from any cause | Trial comparisons |
| NT-501 vs Sham: serious adverse events | Trial comparisons |
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/NCT03319849
GET https://conductscience.org/api/trials/v1/NCT03319849/events?page=2