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

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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)

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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