Trial · NCT00972374
Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function
NCT00972374, Phase 2, Completed, Allergan; results first posted 2013-04-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function. Trials, record NCT00972374. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00972374
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function
- NCT number
- NCT00972374
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Rhegmatogenous Macula-off Retinal Detachment
- Interventions
- 400 ug Brimonidine Implant, 200 ug Brimonidine Implant, Sham (no implant)
- First posted
- 2009-09-04
- Last updated
- 2013-04-24
- Results first posted
- 2013-04-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Month 3 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported. |
| Secondary | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline, Month 3 | 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. |
| Other | Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit | 12 Months | IOP is the fluid pressure inside the eye. The percentage of patients with IOP \< 10 millimeters of mercury (mmHg) in the study eye at any follow up visit is presented. |
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 | Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Month 3 | Intent to Treat: all randomized patients | Percentage of Patients | NUMBER |
| SECONDARY | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline, Month 3 | Intent to Treat: all randomized patients | Number of Letters Read Correctly | MEAN |
| OTHER_PRE_SPECIFIED | Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit | 12 Months | Intent to Treat: all randomized patients | Percentage of Patients | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 400 ug Brimonidine Implant | 6.7 | Percentage of Patients | ||
| Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 200 ug Brimonidine Implant | 6.7 | Percentage of Patients | ||
| Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Sham (no Implant) | 0 | Percentage of Patients | ||
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 400 ug Brimonidine Implant | Baseline | 46.6 | Standard Deviation 13.69 | Number of Letters Read Correctly |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 200 ug Brimonidine Implant | Baseline | 53.3 | Standard Deviation 8.46 | Number of Letters Read Correctly |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Sham (no Implant) | Baseline | 50.3 | Standard Deviation 10.92 | Number of Letters Read Correctly |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 400 ug Brimonidine Implant | Change from Baseline at Month 3 | 6.0 | Standard Deviation 6.23 | Number of Letters Read Correctly |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | 200 ug Brimonidine Implant | Change from Baseline at Month 3 | 3.1 | Standard Deviation 6.78 | Number of Letters Read Correctly |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Sham (no Implant) | Change from Baseline at Month 3 | 4.8 | Standard Deviation 4.64 | Number of Letters Read Correctly |
| Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit | 400 ug Brimonidine Implant | 20.0 | Percentage of Patients |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 400 ug Brimonidine Implant | 15 | |
| Overall Study | STARTED | 200 ug Brimonidine Implant | 15 | |
| Overall Study | STARTED | Sham (no Implant) | 14 | |
| Overall Study | COMPLETED | 400 ug Brimonidine Implant | 13 | |
| Overall Study | COMPLETED | 200 ug Brimonidine Implant | 15 | |
| Overall Study | COMPLETED | Sham (no Implant) | 13 | |
| Overall Study | NOT COMPLETED | 400 ug Brimonidine Implant | 2 | |
| Overall Study | NOT COMPLETED | 200 ug Brimonidine Implant | 0 | |
| Overall Study | NOT COMPLETED | Sham (no Implant) | 1 |
Source ClinicalTrials.gov
Adverse events198
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 ug Brimonidine Implant | 3 | 15 | |
| other | Conjunctival Haemorrhage | Eye disorders | 200 ug Brimonidine Implant | 1 | 15 | |
| other | Conjunctival Haemorrhage | Eye disorders | Sham (no Implant) | 2 | 14 | |
| other | Conjunctival Hyperaemia | Eye disorders | 400 ug Brimonidine Implant | 2 | 15 | |
| other | Conjunctival Hyperaemia | Eye disorders | 200 ug Brimonidine Implant | 1 | 15 | |
| other | Conjunctival Hyperaemia | Eye disorders | Sham (no Implant) | 1 | 14 | |
| other | Eye Pruritus | Eye disorders | 400 ug Brimonidine Implant | 2 | 15 | |
| other | Eye Pruritus | Eye disorders | 200 ug Brimonidine Implant | 0 | 15 | |
| other | Eye Pruritus | Eye disorders | Sham (no Implant) | 0 | 14 | |
| other | Eye Pain | Eye disorders | 400 ug Brimonidine Implant | 1 | 15 |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 400 ug Brimonidine Implant | ||
| Total, all-cause mortality | 200 ug Brimonidine Implant | ||
| Total, all-cause mortality | Sham (no Implant) | ||
| Total, other adverse events | 400 ug Brimonidine Implant | 7 | 15 |
| Total, other adverse events | 200 ug Brimonidine Implant | 12 | 15 |
| Total, other adverse events | Sham (no Implant) | 9 | 14 |
| Total, serious adverse events | 400 ug Brimonidine Implant | 0 | 15 |
| Total, serious adverse events | 200 ug Brimonidine Implant | 2 | 15 |
| Total, serious adverse events | Sham (no Implant) | 2 | 14 |
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/NCT00972374
GET https://conductscience.org/api/trials/v1/NCT00972374/events?page=2