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

NCT00661479 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2013-04-24

Study results available
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Summary

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.

Conditions

Interventions

DRUG

400 µg Brimonidine Tartrate Implant

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

DRUG

200 µg Brimonidine Tartrate Implant

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

DRUG

100 µg Brimonidine Tartrate Implant

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

OTHER

Sham (no implant)

Sham in the fellow eye on Day 1.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-12-31
Completion
2010-05-31

Countries

  • United States
  • France
  • Germany
  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00661479 on ClinicalTrials.gov