Trial · NCT01530659
Retinal Imaging in CNTF -Releasing Encapsulated Cell Implant Treated Patients for Early-stage Retinitis Pigmentosa
NCT01530659, Phase 2, Completed, Neurotech Pharmaceuticals; results first posted 2023-02-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Retinal Imaging in CNTF -Releasing Encapsulated Cell Implant Treated Patients for Early-stage Retinitis Pigmentosa. Trials, record NCT01530659. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01530659
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Retinal Imaging in CNTF -Releasing Encapsulated Cell Implant Treated Patients for Early-stage Retinitis Pigmentosa
- NCT number
- NCT01530659
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Neurotech Pharmaceuticals
- Conditions
- Retinitis Pigmentosa, Usher Syndrome Type 2, Usher Syndrome Type 3
- Interventions
- NT-501, Sham
- First posted
- 2012-02-10
- Last updated
- 2023-02-14
- Results first posted
- 2023-02-14
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Cone Spacing in Arcminutes (Z Score) of 2 Baseline Values Were Compared With Measurements Obtained at Post-op Month 36 | Post-op Month 36 | Average of cone spacing (nearest neighbor distance) at all regions of interest with at least 50 contiguous unambiguous cones identified over the central 5.7 degrees of the macula using confocal AOSLO at two baseline visits within each eye. Cone spacing measures were converted to Z scores based on normal mean values at similar distances from the fovea from a database of 27 age-similar normal eyes. The mean of 2 baseline cone spacing Z-score values were subtracted from the cone spacing Z score values obtained at post-op month 36 A Z-score of 0 represents the mean cone spacing value at the distance from the fovea measured from 27 healthy subjects. A Z-score greater than +2 represents an abnormally increased cone spacing value at the distance from the fovea where the measurement was performed. This suggests fewer cones are present than normal at that location. |
| Secondary | Difference in logMAR Visual Acuity Change Between CNTF- and Sham Treated Eyes | Post-op Month 36 | Difference in change in logMAR visual acuity between NT-501 and contralateral sham-treated eyes. Change in visual acuity was measured based on the number of letters read on a vision chart using a standard protocol. The log of the mean angle of resolution (logMAR) was used to describe the size of the smallest letters that the patient could read. A logMAR value of 0.00 corresponds to visual acuity of 20/20, a logMAR value of 0.3 corresponds to visual acuity of 20/40, a logMAR value of 0.7 corresponds to visual acuity of 20/100, and a logMAR value of 1.00 corresponds to visual acuity of 20/200. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Cone Spacing in Arcminutes (Z Score) of 2 Baseline Values Were Compared With Measurements Obtained at Post-op Month 36 | Post-op Month 36 | Measure type: difference from mean baseline to 36 months in change between intervention and control eyes in mean cone spacing Z score averaged over regions of interest in each eye. | Difference in change in Z score | MEAN |
| SECONDARY | Difference in logMAR Visual Acuity Change Between CNTF- and Sham Treated Eyes | Post-op Month 36 | Difference in change in logMAR visual acuity between NT-501 and contralateral sham-treated eyes. | logMAR | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Cone Spacing in Arcminutes (Z Score) of 2 Baseline Values Were Compared With Measurements Obtained at Post-op Month 36 | NT-501 Implant | 1.13 | Standard Deviation 1.03 | Difference in change in Z score | |
| Mean Change in Cone Spacing in Arcminutes (Z Score) of 2 Baseline Values Were Compared With Measurements Obtained at Post-op Month 36 | Sham Surgery | 0.85 | Standard Deviation 1.78 | Difference in change in Z score | |
| Difference in logMAR Visual Acuity Change Between CNTF- and Sham Treated Eyes | NT-501 Implant | 0.004 | Standard Deviation 0.010 | logMAR | |
| Difference in logMAR Visual Acuity Change Between CNTF- and Sham Treated Eyes | Sham Surgery | 0.014 | Standard Deviation 0.082 | logMAR |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NT-501 Implant | 22 | 22 |
| Overall Study | STARTED | Sham Surgery | 22 | 22 |
| Overall Study | COMPLETED | NT-501 Implant | 22 | 22 |
| Overall Study | COMPLETED | Sham Surgery | 22 | 22 |
| Overall Study | NOT COMPLETED | NT-501 Implant | 0 | 0 |
| Overall Study | NOT COMPLETED | Sham Surgery | 0 | 0 |
Source ClinicalTrials.gov
Adverse events27
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 | Epiretinal membrane | Eye disorders | NT-501 Implant | 1 | 22 | |
| other | Epiretinal membrane | Eye disorders | Sham Surgery | 0 | 22 | |
| other | Epiretinal membrane | Eye disorders | Prior to Randomization | 0 | ||
| other | Pelvic fracture | Musculoskeletal and connective tissue disorders | NT-501 Implant | 1 | 22 | |
| other | Pelvic fracture | Musculoskeletal and connective tissue disorders | Sham Surgery | 1 | 22 | |
| other | Pelvic fracture | Musculoskeletal and connective tissue disorders | Prior to Randomization | 0 | ||
| serious | Pregnancy | Pregnancy, puerperium and perinatal conditions | NT-501 Implant | 1 | 22 | |
| serious | Pregnancy | Pregnancy, puerperium and perinatal conditions | Sham Surgery | 1 | 22 | |
| serious | Pregnancy | Pregnancy, puerperium and perinatal conditions | Prior to Randomization | 0 | 0 | 0 |
| serious | Reversible Cardiac Vasospasm | Cardiac disorders | NT-501 Implant | 1 | 22 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NT-501 Implant | 0 | 22 |
| Total, all-cause mortality | Sham Surgery | 0 | 22 |
| Total, all-cause mortality | Prior to Randomization | 1 | 1 |
| Total, other adverse events | NT-501 Implant | 2 | 22 |
| Total, other adverse events | Sham Surgery | 1 | 22 |
| Total, other adverse events | Prior to Randomization | 0 | 0 |
| Total, serious adverse events | NT-501 Implant | 4 | 22 |
| Total, serious adverse events | Sham Surgery | 4 | 22 |
| Total, serious adverse events | Prior to Randomization | 0 | 0 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT01530659
GET https://conductscience.org/api/trials/v1/NCT01530659/events?page=2