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Phase 2 N=21 Single-blind Treatment

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

Retinitis Pigmentosa

Bottom Line

View on ClinicalTrials.gov: NCT00661479 ↗
Enrolled (actual)
21
Serious AEs
9.5%
Results posted
Apr 2013
Primary outcome: Primary: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye — 48.5; 51.0; 52.7; 4.0 Number of Letters Read Correctly

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
400 µg Brimonidine Tartrate Implant (Drug); 200 µg Brimonidine Tartrate Implant (Drug); 100 µg Brimonidine Tartrate Implant (Drug); Sham (no implant) (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Allergan
Primary completion
Dec 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye		 48.5; 51.0; 52.7; 4.0; 3.2; -1.3 —
SECONDARY
Change From Baseline in Contrast Sensitivity in the Study Eye		 15.5; 18.0; 22.3; 3.0; 0.8; -0.3 —

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00661479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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