Trial · NCT00661479
An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa
NCT00661479, Phase 1, Phase 2, Completed, Allergan; results first posted 2013-04-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa. Trials, record NCT00661479. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00661479
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa
- NCT number
- NCT00661479
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Retinitis Pigmentosa
- Interventions
- 400 µg Brimonidine Tartrate Implant, 200 µg Brimonidine Tartrate Implant, 100 µg Brimonidine Tartrate Implant, Sham (no implant)
- First posted
- 2008-04-18
- Last updated
- 2013-04-24
- Results first posted
- 2013-04-24
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline, Month 6 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. |
| Secondary | Change From Baseline in Contrast Sensitivity in the Study Eye | Baseline, Month 6 | Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement. |
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 | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline, Month 6 | Safety Population: all patients treated on Day 1 | Number of Letters Read Correctly | MEAN |
| SECONDARY | Change From Baseline in Contrast Sensitivity in the Study Eye | Baseline, Month 6 | Safety Population: all patients treated on Day 1 | Number of Letters Read Correctly | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 400 µg Brimonidine Tartrate Implant Group B | Baseline | 48.5 | Standard Deviation 14.61 | Number of Letters Read Correctly |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 200 µg Brimonidine Tartrate Implant Group B | Baseline | 51.0 | Standard Deviation 14.18 | Number of Letters Read Correctly |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 100 µg Brimonidine Tartrate Implant Group B | Baseline | 52.7 | Standard Deviation 3.79 | Number of Letters Read Correctly |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 100 µg Brimonidine Tartrate Implant Group A | Baseline | 4.0 | Standard Deviation 3.46 | Number of Letters Read Correctly |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 400 µg Brimonidine Tartrate Implant Group B | Change from Baseline at Month 6 | 3.2 | Standard Deviation 4.41 | Number of Letters Read Correctly |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 200 µg Brimonidine Tartrate Implant Group B | Change from Baseline at Month 6 | -1.3 | Standard Deviation 4.04 | Number of Letters Read Correctly |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 100 µg Brimonidine Tartrate Implant Group B | Change from Baseline at Month 6 | 3.3 | Standard Deviation 8.50 | Number of Letters Read Correctly |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 100 µg Brimonidine Tartrate Implant Group A | Change from Baseline at Month 6 | 0.3 | Standard Deviation 3.79 | Number of Letters Read Correctly |
| Change From Baseline in Contrast Sensitivity in the Study Eye | 400 µg Brimonidine Tartrate Implant Group B | Baseline | 15.5 | Standard Deviation 8.48 | Number of Letters Read Correctly |
| Change From Baseline in Contrast Sensitivity in the Study Eye | 200 µg Brimonidine Tartrate Implant Group B | Baseline | 18.0 | Standard Deviation 7.21 | Number of Letters Read Correctly |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 400 µg Brimonidine Tartrate Implant Group B | 12 | |
| Overall Study | STARTED | 200 µg Brimonidine Tartrate Implant Group B | 3 | |
| Overall Study | STARTED | 100 µg Brimonidine Tartrate Implant Group B | 3 | |
| Overall Study | STARTED | 100 µg Brimonidine Tartrate Implant Group A | 3 | |
| Overall Study | COMPLETED | 400 µg Brimonidine Tartrate Implant Group B | 12 | |
| Overall Study | COMPLETED | 200 µg Brimonidine Tartrate Implant Group B | 3 | |
| Overall Study | COMPLETED | 100 µg Brimonidine Tartrate Implant Group B | 3 | |
| Overall Study | COMPLETED | 100 µg Brimonidine Tartrate Implant Group A | 3 | |
| Overall Study | NOT COMPLETED | 400 µg Brimonidine Tartrate Implant Group B | 0 | |
| Overall Study | NOT COMPLETED | 200 µg Brimonidine Tartrate Implant Group B | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events180
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 | Conjunctival Haemorrhage | Eye disorders | 400 µg Brimonidine Tartrate Implant Group B | 5 | 12 | |
| other | Conjunctival Haemorrhage | Eye disorders | 200 µg Brimonidine Tartrate Implant Group B | 2 | 3 | |
| other | Conjunctival Haemorrhage | Eye disorders | 100 µg Brimonidine Tartrate Implant Groups A and B | 1 | 6 | |
| other | Conjunctival Hyperaemia | Eye disorders | 400 µg Brimonidine Tartrate Implant Group B | 5 | 12 | |
| other | Conjunctival Hyperaemia | Eye disorders | 200 µg Brimonidine Tartrate Implant Group B | 3 | 3 | |
| other | Conjunctival Hyperaemia | Eye disorders | 100 µg Brimonidine Tartrate Implant Groups A and B | 5 | 6 | |
| other | Foreign Body Sensation in Eyes | Eye disorders | 400 µg Brimonidine Tartrate Implant Group B | 3 | 12 | |
| other | Foreign Body Sensation in Eyes | Eye disorders | 200 µg Brimonidine Tartrate Implant Group B | 0 | 3 | |
| other | Foreign Body Sensation in Eyes | Eye disorders | 100 µg Brimonidine Tartrate Implant Groups A and B | 1 | 6 | |
| other | Ocular Discomfort | Eye disorders | 400 µg Brimonidine Tartrate Implant Group B | 3 | 12 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 400 µg Brimonidine Tartrate Implant Group B | ||
| Total, all-cause mortality | 200 µg Brimonidine Tartrate Implant Group B | ||
| Total, all-cause mortality | 100 µg Brimonidine Tartrate Implant Groups A and B | ||
| Total, other adverse events | 400 µg Brimonidine Tartrate Implant Group B | 11 | 12 |
| Total, other adverse events | 200 µg Brimonidine Tartrate Implant Group B | 3 | 3 |
| Total, other adverse events | 100 µg Brimonidine Tartrate Implant Groups A and B | 6 | 6 |
| Total, serious adverse events | 400 µg Brimonidine Tartrate Implant Group B | 1 | 12 |
| Total, serious adverse events | 200 µg Brimonidine Tartrate Implant Group B | 0 | 3 |
| Total, serious adverse events | 100 µg Brimonidine Tartrate Implant Groups A and B | 1 | 6 |
Source ClinicalTrials.gov
Papers0
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/NCT00661479
GET https://conductscience.org/api/trials/v1/NCT00661479/events?page=2