Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
400 µg Brimonidine · 3 trials · 3 indications
Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm\^2).
The highest level of brimonidine measured in the vitreous humor of the study eye in any patient is reported for each treatment arm. The vitreous humor is the clear gel that fills the space between the lens and the retina of the eye.
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.
| Arm | Type | Description |
|---|---|---|
| 400 µg Brimonidine Tartrate Implant Stage 1 | OTHER | Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| 200 µg Brimonidine Tartrate Implant Stage 1 | OTHER | Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| 400 µg Brimonidine Tartrate Implant Stage 2 | OTHER | Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| 200 µg Brimonidine Tartrate Implant Stage 2 | OTHER | Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| Sham (no implant) Stage 2 | SHAM_COMPARATOR | Stage 2: sham in both eyes on Day 1 and Month 6. |
| 400 µg Brimonidine Tartrate Implant | EXPERIMENTAL | 400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). |
| 200 µg Brimonidine Tartrate Implant | EXPERIMENTAL | 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). |
| 400 µg Brimonidine Tartrate Implant Group B | EXPERIMENTAL | 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| 200 µg Brimonidine Tartrate Implant Group B | EXPERIMENTAL | 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| 100 µg Brimonidine Tartrate Implant Group B | EXPERIMENTAL | 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| 100 µg Brimonidine Tartrate Implant Group A | EXPERIMENTAL | 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| Name | Type | Description |
|---|---|---|
| 400 µg Brimonidine Tartrate Implant | DRUG | 400 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6. |
| 200 µg Brimonidine Tartrate Implant | DRUG | 200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6. |
| Sham (no implant) | OTHER | Sham in one or both eyes on Day 1 and Month 6. |
| 100 µg Brimonidine Tartrate Implant | DRUG | 100 µg brimonidine tartrate implant in the study eye on Day 1. |
Inclusion Criteria: * Geographic atrophy in both eyes due to age-related macular degeneration * Visual acuity between 20/40 to 20/320 Exclusion Criteria: * Known allergy to brimonidine * Uncontrolled systemic disease or infection of the eye * Recent eye surgery or injections in the eye * Female p...
400 µg Brimonidine is an investigational small molecule being studied for use in ophthalmology, specifically for retinitis pigmentosa, vitrectomy, and macular degeneration. It is delivered as an intravitreal implant. The drug is not approved and remains in clinical development.
400 µg Brimonidine is being developed by AbbVie Inc., which trades under the ticker ABBV. The company is conducting clinical trials to evaluate the safety and efficacy of this intravitreal implant in patients with various eye conditions.
400 µg Brimonidine is in Phase 2 clinical development. One Phase 2 trial has been completed, along with two Phase 1 trials. The drug is investigational and has not received FDA approval.
400 µg Brimonidine has been studied in three completed trials. NCT00658619 was a Phase 2 sham-controlled study in 119 patients with geographic atrophy due to age-related macular degeneration. NCT00661479 was a Phase 1 study in 21 patients with retinitis pigmentosa. NCT01229410 was a Phase 1 pharmacokinetic study in 24 patients undergoing vitrectomy.
400 µg Brimonidine is a specific dosage form of the drug brimonidine, delivered as an intravitreal implant. It is being studied for posterior segment eye diseases. The 400 µg dose refers to the amount of brimonidine in the implant.