Phase 2
N=119
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)
Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00658619 ↗Enrolled (actual)
119
Serious AEs
36.8%
Results posted
Apr 2013
Primary outcome: Primary: Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye — 6.219; 6.897; 5.526; 0.898 Disc Area
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 400 µg Brimonidine Tartrate Implant (Drug); 200 µg Brimonidine Tartrate Implant (Drug); Sham (no implant) (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye |
6.219; 6.897; 5.526; 0.182; 0.117; 0.399 | — |
| SECONDARY Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye |
6.219; 6.897; 5.526; 0.182; 0.117; 0.399 | — |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye |
54.8; 52.1; 53.7; -5.0; -3.2; -3.3 | — |
| SECONDARY Change From Baseline in Contrast Sensitivity in the Study Eye |
23.7; 22.1; 21.7; -0.9; 1.1; 0.6 | — |
| SECONDARY Change From Baseline in Reading Speed in the Study Eye |
10.21; 9.62; 8.72; -1.15; -0.28; 0.45 | — |
Summary
Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1. Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from age-related macular degeneration. Patients will be followed for up to 2 years.
Eligibility Criteria
Inclusion Criteria
- Geographic atrophy in both eyes due to age-related macular degeneration
- Visual acuity between 20/40 to 20/320
Exclusion Criteria
- Known allergy to brimonidine
- 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
Data sourced from ClinicalTrials.gov (NCT00658619). 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.