Trial · NCT00447993
A Study of Encapsulated Cell Technology (ECT) Implant for Patients With Late Stage Retinitis Pigmentosa
NCT00447993, Phase 2, Completed, Neurotech Pharmaceuticals; results first posted 2024-08-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Encapsulated Cell Technology (ECT) Implant for Patients With Late Stage Retinitis Pigmentosa. Trials, record NCT00447993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00447993
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Encapsulated Cell Technology (ECT) Implant for Patients With Late Stage Retinitis Pigmentosa
- NCT number
- NCT00447993
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 67 participants, actual
- Lead sponsor
- Neurotech Pharmaceuticals
- Conditions
- Retinitis Pigmentosa
- Interventions
- Low Dose NT-501, High Dose NT-501
- First posted
- 2007-03-15
- Last updated
- 2024-08-13
- Results first posted
- 2024-08-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Outcome is the Change in Best-corrected Visual Acuity (BCVA) Using the Electronic Visual Acuity (EVA) Technology at Month 12. | 12 months post-implant | The primary efficacy endpoint was the proportion of patients demonstrating an improvement in best-corrected visual acuity (BCVA), defined as an increase of 10 letters or more at the 1-Year post-implant visit (pre-explant, if explant is completed). No response is defined as an improvement of \<10 letters. |
| Secondary | Number of Participants With and Without Best Corrected Visual Acuity Response Over the 18-month Follow-up Period (Months 1, 3, 6, 12 and 18) | From initial implant to 18 months post-implant | The key visits for efficacy assessments were Months 1, 3, 6, 12 and 18. At these time points, BCVA was measured 3 times and the mean outcome reported. The assessments were conducted by masked technicians. The change from baseline for BCVA was summarized by time. Response is defined as an improvement in visual acuity by an increase of 10 letters or more whereas no response is \<10 letters. |
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 | The Primary Outcome is the Change in Best-corrected Visual Acuity (BCVA) Using the Electronic Visual Acuity (EVA) Technology at Month 12. | 12 months post-implant | Results are based on participants who completed the 1-yr post implant visit/assessment. | participants | NUMBER |
| SECONDARY | Number of Participants With and Without Best Corrected Visual Acuity Response Over the 18-month Follow-up Period (Months 1, 3, 6, 12 and 18) | From initial implant to 18 months post-implant | Data set provides details for each timepoint based on number of patients who completed BCVA procedure at the each applicable visit. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Outcome is the Change in Best-corrected Visual Acuity (BCVA) Using the Electronic Visual Acuity (EVA) Technology at Month 12. | Low Dose Arm - Implant | Response (Greater than or equal to 10 letter improvement) | 1 | participants | |
| The Primary Outcome is the Change in Best-corrected Visual Acuity (BCVA) Using the Electronic Visual Acuity (EVA) Technology at Month 12. | Low Dose Arm - Sham | Response (Greater than or equal to 10 letter improvement) | 1 | participants | |
| The Primary Outcome is the Change in Best-corrected Visual Acuity (BCVA) Using the Electronic Visual Acuity (EVA) Technology at Month 12. | High Dose | Response (Greater than or equal to 10 letter improvement) | 3 | participants | |
| The Primary Outcome is the Change in Best-corrected Visual Acuity (BCVA) Using the Electronic Visual Acuity (EVA) Technology at Month 12. | High Dose Arm - Sham | Response (Greater than or equal to 10 letter improvement) | 1 | participants | |
| The Primary Outcome is the Change in Best-corrected Visual Acuity (BCVA) Using the Electronic Visual Acuity (EVA) Technology at Month 12. | Low Dose Arm - Implant | No Response | 20 | participants | |
| The Primary Outcome is the Change in Best-corrected Visual Acuity (BCVA) Using the Electronic Visual Acuity (EVA) Technology at Month 12. | Low Dose Arm - Sham | No Response | 20 | participants | |
| The Primary Outcome is the Change in Best-corrected Visual Acuity (BCVA) Using the Electronic Visual Acuity (EVA) Technology at Month 12. | High Dose | No Response | 39 | participants | |
| The Primary Outcome is the Change in Best-corrected Visual Acuity (BCVA) Using the Electronic Visual Acuity (EVA) Technology at Month 12. | High Dose Arm - Sham | No Response | 41 | participants | |
| Number of Participants With and Without Best Corrected Visual Acuity Response Over the 18-month Follow-up Period (Months 1, 3, 6, 12 and 18) | Low Dose Arm - Implant | 1 month post-implant: Response | 1 | Participants | |
| Number of Participants With and Without Best Corrected Visual Acuity Response Over the 18-month Follow-up Period (Months 1, 3, 6, 12 and 18) | Low Dose Arm - Sham | 1 month post-implant: Response | 1 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low Dose Arm - Implant | 22 | 22 |
| Overall Study | STARTED | Low Dose Arm - Sham | 22 | 22 |
| Overall Study | STARTED | High Dose Arm - Implant | 45 | 45 |
| Overall Study | STARTED | High Dose Arm - Sham | 45 | 45 |
| Overall Study | COMPLETED | Low Dose Arm - Implant | 22 | 22 |
| Overall Study | COMPLETED | Low Dose Arm - Sham | 22 | 22 |
| Overall Study | COMPLETED | High Dose Arm - Implant | 41 | 41 |
| Overall Study | COMPLETED | High Dose Arm - Sham | 41 | 41 |
| Overall Study | NOT COMPLETED | Low Dose Arm - Implant | 0 | 0 |
| Overall Study | NOT COMPLETED | Low Dose Arm - Sham | 0 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events70
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 | Abnormal sensation in eye | Eye disorders | Low Dose | 2 | 22 | 2 |
| other | Abnormal sensation in eye | Eye disorders | High Dose | 2 | 43 | 2 |
| other | Anterior chamber cell | Eye disorders | Low Dose | 7 | 22 | 7 |
| other | Anterior chamber cell | Eye disorders | High Dose | 12 | 43 | 12 |
| other | Anterior chamber flare | Eye disorders | Low Dose | 5 | 22 | 5 |
| other | Anterior chamber flare | Eye disorders | High Dose | 10 | 43 | 10 |
| other | Cataract | Eye disorders | Low Dose | 1 | 22 | 1 |
| other | Cataract | Eye disorders | High Dose | 2 | 43 | 2 |
| other | Conjunctival cyst | Eye disorders | Low Dose | 2 | 22 | 2 |
| other | Conjunctival cyst | Eye disorders | High Dose | 1 | 43 | 1 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Dose | 0 | 22 |
| Total, all-cause mortality | High Dose | 0 | 43 |
| Total, other adverse events | Low Dose | 22 | 22 |
| Total, other adverse events | High Dose | 42 | 43 |
| Total, serious adverse events | Low Dose | 1 | 22 |
| Total, serious adverse events | High Dose | 0 | 22 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Low Dose vs High Dose: deaths from any cause | Trial comparisons |
| Low Dose vs High Dose: 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/NCT00447993
GET https://conductscience.org/api/trials/v1/NCT00447993/results?page=2