An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa

Allergan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Retinitis Pigmentosa

Treatments: Drug: 200 µg Brimonidine Tartrate Implant; Other: Sham (no implant); Drug: 100 µg Brimonidine Tartrate Implant; Drug: 400 µg Brimonidine Tartrate Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00661479

190342-028D

Details and patient eligibility

About

This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Retinitis Pigmentosa in both eyes
• Visual acuity between 20/40 to count fingers

Exclusion criteria

• Growth of new blood vessels in the eye
• Any intraocular surgery or laser in either eye in the last 6 months prior to Screening visit or between the Screening visit and Day 1
• Any ocular disease that can interfere with diagnosis and or assessment of disease progression
• Significant near-sightedness
• HIV
• Female patients who are pregnant, nursing, or planning pregnancy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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21 participants in 4 patient groups

400 µg Brimonidine Tartrate Implant Group B

Experimental group

Description:

400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.

Treatment:

Drug: 400 µg Brimonidine Tartrate Implant

Other: Sham (no implant)

200 µg Brimonidine Tartrate Implant Group B

Experimental group

Description:

200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.

Treatment:

Other: Sham (no implant)

Drug: 200 µg Brimonidine Tartrate Implant

100 µg Brimonidine Tartrate Implant Group B

Experimental group

Description:

100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.

Treatment:

Drug: 100 µg Brimonidine Tartrate Implant

Other: Sham (no implant)

100 µg Brimonidine Tartrate Implant Group A

Experimental group

Description:

100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.

Treatment:

Drug: 100 µg Brimonidine Tartrate Implant

Other: Sham (no implant)