Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function

Allergan

Status and phase: Completed; Phase 2

Conditions: Rhegmatogenous Macula-off Retinal Detachment

Treatments: Drug: 200 ug Brimonidine Implant; Other: Sham (no implant); Drug: 400 ug Brimonidine Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00972374

190342-031D

Details and patient eligibility

About

This study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200 μg and 400 μg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 success and required no more than one macular re-attachment procedure
• The visual acuity score must be between 20/50 and 20/320 in the study eye

Exclusion criteria

• Any sight-threatening ocular condition in the study eye other than the ruptured retinal detachment
• Anticipated need for ocular surgery during the 12-month study period
• Any injectable, periocular, or intravitreal corticosteroid treatment to study eye within 6 months prior to screening (eg, triamcinolone acetonide)
• Any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis)
• Any infectious condition in the study eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

44 participants in 3 patient groups

400 ug Brimonidine Implant

Experimental group

Description:

400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.

Treatment:

Drug: 400 ug Brimonidine Implant

200 ug Brimonidine Implant

Experimental group

Description:

200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.

Treatment:

Drug: 200 ug Brimonidine Implant

Sham (no implant)

Sham Comparator group

Description:

Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.

Treatment:

Other: Sham (no implant)