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Trial record 1 of 1 for:    NCT02087085
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A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration (BEACON)

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ClinicalTrials.gov Identifier: NCT02087085
Recruitment Status : Terminated
First Posted : March 14, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will assess the safety and efficacy of the brimonidine intravitreal implant in patients with geographic atrophy due to age-related macular degeneration.

Condition or disease Intervention/treatment Phase
Geographic Atrophy Macular Degeneration Drug: 400 µg Brimonidine Implant Other: Sham Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
Actual Study Start Date : May 9, 2016
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 400 µg Brimonidine Implant
400 µg brimonidine implant in the study eye on Day 1, and every 3 months through Month 21.
Drug: 400 µg Brimonidine Implant
400 µg brimonidine implant in the study eye on Day 1, and every 3 months through Month 21.

Sham Comparator: Sham
Sham treatment with needleless applicator (no implant) to the study eye on Day 1, and every 3 months through Month 21.
Other: Sham
Sham treatment with needleless applicator (no implant) to the study eye on Day 1, and every 3 months through Month 21.




Primary Outcome Measures :
  1. Change from Baseline in Atrophic Lesion Area in the Study Eye [ Time Frame: Baseline, Month 24 ]

Secondary Outcome Measures :
  1. Change from Baseline in Low Luminance Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, Month 24 ]
  2. Change from Baseline in BCVA in the Study Eye [ Time Frame: Baseline, Month 24 ]

Other Outcome Measures:
  1. Change from Baseline in Retinal Sensitivity in the Study Eye [ Time Frame: Baseline, Month 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Geographic atrophy due to age-related macular degeneration in the study eye
  • Visual acuity better than or equal to 20/125 in the study eye and 20/200 in the fellow eye

Exclusion Criteria:

  • Cataract surgery or Laser-Assisted in situ Keratomileusis (LASIK) in the study eye in the last 3 months
  • Infections in either eye in the last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087085


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Sponsors and Collaborators
Allergan
Investigators
Study Director: Francesco Lopez Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02087085     History of Changes
Other Study ID Numbers: 190342-038
2013-003320-36 ( EudraCT Number )
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Brimonidine Tartrate
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs