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

Allergan21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Retinitis Pigmentosa

Interventions

400 µg Brimonidine Tartrate ImplantDRUG

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

200 µg Brimonidine Tartrate ImplantDRUG

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

100 µg Brimonidine Tartrate ImplantDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Unnamed facility

Arlington, Texas, United States

Unnamed facility

Paris, France

Unnamed facility

Tübingen, Germany

Unnamed facility

Coimbra, Portugal

Outcomes

Primary Outcomes

Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study 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.

Time frame: Baseline, Month 6

Secondary Outcomes

Change From Baseline in Contrast Sensitivity in the Study Eye

Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.

Time frame: Baseline, Month 6

Data from ClinicalTrials.gov

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