Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Brimonidine · 2 trials · 2 indications
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.
Visual field improvement in the study eye is determined using the Humphrey Field Analyzer (HFA 24-2) full threshold test and clinical expertise. The Humphrey Field Analyzer is a machine that helps to map the field (peripheral) of vision. An improvement is an increase in the field of vision. The percentage of patients with a visual field improvement in the study eye is reported.
| Arm | Type | Description |
|---|---|---|
| 400 ug Brimonidine Implant | EXPERIMENTAL | 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| 200 ug Brimonidine Implant | EXPERIMENTAL | 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| Sham (no implant) | SHAM_COMPARATOR | Sham Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| Name | Type | Description |
|---|---|---|
| 400 ug Brimonidine Implant | DRUG | 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| 200 ug Brimonidine Implant | DRUG | 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| Sham (no implant) | OTHER | Sham Posterior Segment Drug Delivery system on Day 1 in the study eye. |
Inclusion Criteria: * The macula-off retinal detachment must have been caused by a rupture (rhegmatogenous in etiology) * The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye * The repair must have been deemed an anatomic succe...
Brimonidine is an investigational small molecule being studied for use in glaucoma, open-angle glaucoma, ocular hypertension, and rhegmatogenous macula-off retinal detachment. It is being developed by AbbVie Inc. (ABBV) for these ophthalmology indications.
Brimonidine is an alpha-2 adrenergic receptor agonist. It works by reducing the production of aqueous humor in the eye, which helps lower intraocular pressure in conditions like glaucoma and ocular hypertension.
Brimonidine is being developed by AbbVie Inc., which trades under the ticker ABBV. The company is conducting clinical trials to evaluate the drug for ophthalmology indications including glaucoma and ocular hypertension.
Brimonidine is in Phase 2 clinical development for rhegmatogenous macula-off retinal detachment. It has completed Phase 3 trials for glaucoma and ocular hypertension, but it remains investigational and is not yet approved by the FDA.
Brimonidine has been studied in several completed trials. NCT00168363 and NCT00652483 evaluated its safety and efficacy in glaucoma and ocular hypertension. NCT00652106 tested a brimonidine/timolol fixed combination. NCT00972374 assessed a posterior segment drug delivery system for retinal detachment.
Brimonidine is the active ingredient in Alphagan, a brand name for the drug. The clinical trials listed under Brimonidine test the same active compound, sometimes in combination with other agents like timolol.