Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy

Allergan

Status and phase: Completed; Phase 2

Conditions: Glaucoma, Open-Angle

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00693485

190342-030D

Details and patient eligibility

About

A multicenter, randomized, patient-masked, sham-controlled evaluation of the safety and effects on visual function of brimonidine intravitreal implant in patients with glaucomatous optic neuropathy. Patients will be followed for up to 1 year.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary open-angle glaucoma in one eye
• Visual acuity 20/80 or better
• Intraocular pressure in the study eye ≤ 24 mm Hg
• Glaucomatous visual field loss - 7 dB to - 25 dB

Exclusion criteria

• Known allergy to brimonidine tartrate
• Uncontrolled systemic disease or infection of the eye
• Recent eye surgery or injections in the eye
• Female patients who are pregnant, nursing or planning a pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 3 patient groups

400 ug Brimonidine Implant

Experimental group

Description:

400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

Treatment:

Drug: 400 ug Brimonidine Implant

200 ug Brimonidine Implant

Experimental group

Description:

200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

Treatment:

Drug: 200 ug Brimonidine Implant

Sham (no implant)

Sham Comparator group

Description:

Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

Treatment:

Drug: Sham (no implant)