|
|
|
|
|
|
Sponsored by: |
Allergan |
Information provided by: | Allergan |
ClinicalTrials.gov Identifier: | NCT00658619 |
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.
Condition | Intervention | Phase |
Macular Degeneration |
Drug: Brimonidine Tartrate Implant Drug: Sham |
Phase II |
Genetics Home Reference related topics: | X-linked juvenile retinoschisis |
MedlinePlus related topics: | Macular Degeneration |
ChemIDplus related topics: | Brimonidine Brimonidine Tartrate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD |
Estimated Enrollment: | 95 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1
Stage 1: 200 µg Brimonidine Implant in one eye and sham in fellow eye
|
Drug: Brimonidine Tartrate Implant
Stage 1: 200 µg Brimonidine Tartrate Posterior Segment Drug Delivery system Applicator System at day 1 and month 6 in one eye and sham in fellow eye
|
2
Stage 1: 400 µg Brimonidine Implant in one eye and sham in fellow eye
|
Drug: Brimonidine Tartrate Implant
Stage 1: 400 µg Brimonidine Tartrate Posterior Segment Drug Delivery system Applicator System at day 1 and month 6 in one eye and sham in fellow eye
|
3
Stage 2: 200 µg Brimonidine Implant in one eye and sham in fellow eye
|
Drug: Brimonidine Tartrate Implant
Stage 2: 200 µg Brimonidine Tartrate Posterior Segment Drug Delivery system Applicator System at day 1 and month 6 in one eye and sham in fellow eye
|
4
Stage 2: 400 µg Brimonidine Implant in one eye and sham in fellow eye
|
Drug: Brimonidine Tartrate Implant
Stage 2: 400 µg Brimonidine Tartrate Posterior Segment Drug Delivery system Applicator System at day 1 and month 6 in one eye and sham in fellow eye
|
5: Sham Comparator
Stage 2: sham in both eyes
|
Drug: Sham
Sham Posterior Segment Drug Delivery system Applicator System at day 1 and month 6 in both eyes
|
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Allergan Inc | clinicaltrials@allergan.com |
United States, Texas | |||||
Recruiting | |||||
Abilene, Texas, United States | |||||
Korea, Republic of | |||||
Not yet recruiting | |||||
Korea, Korea, Republic of |
Allergan |
Study Director: | Medical Director | Allergan |
Responsible Party: | Allergan, Inc. ( Therapeutic Area Head ) |
Study ID Numbers: | 190342-032D |
First Received: | April 11, 2008 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00658619 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|