Trial · NCT01648452
CNTF Implants for CNGB3 Achromatopsia
NCT01648452, Phase 1, Phase 2, Completed, National Eye Institute (NEI); results first posted 2014-02-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CNTF Implants for CNGB3 Achromatopsia. Trials, record NCT01648452. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01648452
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CNTF Implants for CNGB3 Achromatopsia
- NCT number
- NCT01648452
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- National Eye Institute (NEI)
- Conditions
- Eye Disease, Achromatopsia
- Interventions
- NT-501 CNTF-releasing implant
- First posted
- 2012-07-24
- Last updated
- 2016-11-21
- Results first posted
- 2014-02-25
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Adverse Events at Six Months Post-Implantation | Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation | The primary outcome is the total number of adverse events reported within six months post-implantation. |
| Primary | Number of Severe Adverse Events at Six Months Post-Implantation | Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation | The number of severe adverse events reported within six months post-implantation. |
| Primary | Number of Ocular Adverse Events at Six Months Post-Implantation | Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation | The number of eye-related adverse events reported within six months post-implantation. |
| Primary | Number of Non-Ocular Adverse Events at Six Months Post-Implantation | Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation | The number of non eye-related adverse events reported within six months post-implantation. |
| Secondary | Number of Adverse Events at All Time Points Post-Implantation | Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation | The total number of adverse events reported from Day 1 post-implantation through study completion at Year 3. |
| Secondary | Number of Severe Adverse Events at All Time Points Post-Implantation | Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation | The total number of severe adverse events reported from Day 1 post-implantation through study completion at Year 3. Although there were two serious adverse events (SAEs) reported during the study, only one event's severity was classified as "severe." |
| Secondary | Number of Ocular Adverse Events at All Time Points Post-Implantation | Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation | The total number of eye-related adverse events reported from Day 1 post-implantation through study completion at Year 3. |
| Secondary | Number of Non-Ocular Adverse Events at All Time Points Post-Implantation | Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation | The total number of non eye-related adverse events reported from Day 1 post-implantation through study completion at Year 3. |
| Secondary | Number of Participants Who Experienced an Improvement in Visual Acuity of Greater Than 0.3 logMAR (Logarithm of the Minimum Angle of Resolution) Post-Implantation in the Study Eye. | Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation | Improvement of visual acuity was assessed on both the study and control eyes. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. . The LogMAR scale \[expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30)\] converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA. For example, a visual acuity of 20/20 corresponds to a logMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7. |
| Secondary | Number of Participants Who Experienced an Improvement in Visual Acuity of Greater Than 0.3 logMAR (Logarithm of the Minimum Angle of Resolution) Post-Implantation in the Untreated Control Eye. | Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation | Improvement of visual acuity was assessed on both the study and control eyes. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. . The LogMAR scale \[expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30)\] converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA. For example, a visual acuity of 20/20 corresponds to a logMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Adverse Events at Six Months Post-Implantation | Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation | Adverse Events | NUMBER | |
| PRIMARY | Number of Severe Adverse Events at Six Months Post-Implantation | Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation | Adverse Events | NUMBER | |
| PRIMARY | Number of Ocular Adverse Events at Six Months Post-Implantation | Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation | Adverse Events | NUMBER | |
| PRIMARY | Number of Non-Ocular Adverse Events at Six Months Post-Implantation | Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation | Adverse Events | NUMBER | |
| SECONDARY | Number of Adverse Events at All Time Points Post-Implantation | Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation | Adverse Events | NUMBER | |
| SECONDARY | Number of Severe Adverse Events at All Time Points Post-Implantation | Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation | Adverse Events | NUMBER | |
| SECONDARY | Number of Ocular Adverse Events at All Time Points Post-Implantation | Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation | Adverse Events | NUMBER | |
| SECONDARY | Number of Non-Ocular Adverse Events at All Time Points Post-Implantation | Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation | Adverse Events | NUMBER | |
| SECONDARY | Number of Participants Who Experienced an Improvement in Visual Acuity of Greater Than 0.3 logMAR (Logarithm of the Minimum Angle of Resolution) Post-Implantation in the Study Eye. | Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation | participants | NUMBER | |
| SECONDARY | Number of Participants Who Experienced an Improvement in Visual Acuity of Greater Than 0.3 logMAR (Logarithm of the Minimum Angle of Resolution) Post-Implantation in the Untreated Control Eye. | Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation | participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Adverse Events at Six Months Post-Implantation | NT-501 CNTF-releasing Implant | 10 | Adverse Events | ||
| Number of Severe Adverse Events at Six Months Post-Implantation | NT-501 CNTF-releasing Implant | 1 | Adverse Events | ||
| Number of Ocular Adverse Events at Six Months Post-Implantation | NT-501 CNTF-releasing Implant | 9 | Adverse Events | ||
| Number of Non-Ocular Adverse Events at Six Months Post-Implantation | NT-501 CNTF-releasing Implant | 1 | Adverse Events | ||
| Number of Adverse Events at All Time Points Post-Implantation | NT-501 CNTF-releasing Implant | 15 | Adverse Events | ||
| Number of Severe Adverse Events at All Time Points Post-Implantation | NT-501 CNTF-releasing Implant | 1 | Adverse Events | ||
| Number of Ocular Adverse Events at All Time Points Post-Implantation | NT-501 CNTF-releasing Implant | 11 | Adverse Events | ||
| Number of Non-Ocular Adverse Events at All Time Points Post-Implantation | NT-501 CNTF-releasing Implant | 4 | Adverse Events | ||
| Number of Participants Who Experienced an Improvement in Visual Acuity of Greater Than 0.3 logMAR (Logarithm of the Minimum Angle of Resolution) Post-Implantation in the Study Eye. | NT-501 CNTF-releasing Implant | 0 | participants | ||
| Number of Participants Who Experienced an Improvement in Visual Acuity of Greater Than 0.3 logMAR (Logarithm of the Minimum Angle of Resolution) Post-Implantation in the Untreated Control Eye. | Untreated Control Eye | 0 | participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NT-501 CNTF-releasing Implant | 5 | |
| Overall Study | COMPLETED | NT-501 CNTF-releasing Implant | 5 | |
| Overall Study | NOT COMPLETED | NT-501 CNTF-releasing Implant | 0 |
Source ClinicalTrials.gov
Adverse events22
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 | Arthropod Bite | Injury, poisoning and procedural complications | NT-501 CNTF-releasing Implant Events ≤ 6 Months Post-implant | 1 | 5 | 1 |
| other | Arthropod Bite | Injury, poisoning and procedural complications | NT-501 CNTF-releasing Implant Events > 6 Months Post-implant | 0 | 5 | 0 |
| other | Delayed Dark Adaptation | Eye disorders | NT-501 CNTF-releasing Implant Events ≤ 6 Months Post-implant | 4 | 5 | 4 |
| other | Delayed Dark Adaptation | Eye disorders | NT-501 CNTF-releasing Implant Events > 6 Months Post-implant | 0 | 5 | 0 |
| other | Uveitis | Eye disorders | NT-501 CNTF-releasing Implant Events ≤ 6 Months Post-implant | 1 | 5 | 1 |
| other | Uveitis | Eye disorders | NT-501 CNTF-releasing Implant Events > 6 Months Post-implant | 0 | 5 | 0 |
| other | Vitreous detachment | Eye disorders | NT-501 CNTF-releasing Implant Events ≤ 6 Months Post-implant | 1 | 5 | 1 |
| other | Vitreous detachment | Eye disorders | NT-501 CNTF-releasing Implant Events > 6 Months Post-implant | 0 | 5 | 0 |
| other | Vitritis | Eye disorders | NT-501 CNTF-releasing Implant Events ≤ 6 Months Post-implant | 2 | 5 | 2 |
| other | Vitritis | Eye disorders | NT-501 CNTF-releasing Implant Events > 6 Months Post-implant | 0 | 5 | 0 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NT-501 CNTF-releasing Implant Events ≤ 6 Months Post-implant | ||
| Total, all-cause mortality | NT-501 CNTF-releasing Implant Events > 6 Months Post-implant | ||
| Total, other adverse events | NT-501 CNTF-releasing Implant Events ≤ 6 Months Post-implant | 5 | 5 |
| Total, other adverse events | NT-501 CNTF-releasing Implant Events > 6 Months Post-implant | 2 | 5 |
| Total, serious adverse events | NT-501 CNTF-releasing Implant Events ≤ 6 Months Post-implant | 1 | 5 |
| Total, serious adverse events | NT-501 CNTF-releasing Implant Events > 6 Months Post-implant | 1 | 5 |
Source ClinicalTrials.gov
Papers4
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| NT-501 CNTF-releasing Implant Events ≤ 6 Months Post-implant vs NT-501 CNTF-releasing Implant Events > 6 Months Post-implant: serious adverse events |
Source 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/NCT01648452
GET https://conductscience.org/api/trials/v1/NCT01648452/events?page=2