Patients Who Participated in an Intravitreal Brimo PS DDS® Study Clinical Trial
| Verified date | February 2015 |
| Source | Allergan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.
| Status | Completed |
| Enrollment | 215 |
| Est. completion date | February 2014 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Received the most recent sham or active study treatment of intravitreal Brimo PS DDS® no later than 36 months prior to entry into this study and have either completed their previous study, or have exited early from their previous study for any reason - Applicable studies: Previous Allergan intravitreal Brimo PS DDS® treatment studies Exclusion Criteria: - None |
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Allergan |
United States, Australia, Czech Republic, France, Germany, India, Israel, Italy, Korea, Republic of, Philippines, Portugal, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Patients With No Visible Implants in the Study Eye | Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study. | Month 36 | No |
| Secondary | Number of Patients With Vision Loss in the Study Eye | Vision loss is assessed by Best Corrected Visual Acuity (BCVA) in the study eye. 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). Severe vision loss is a =30 letter decrease in BCVA. Moderate vision loss is a =15 and <30 letter decrease in BCVA. No or mild vision loss is <15 letter decrease in BCVA. Baseline of the parent study is defined as the point of the first study treatment. | Baseline of Parent Study, Month 36 | No |