A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration

Phase 2

Terminated

• Conditions: Macular Degeneration; Geographic Atrophy
• Interventions: Other: Sham; Drug: 400 µg Brimonidine Implant

• Registration Number: NCT02087085
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-14
• Study Start: 2014-05-09
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Status Verified: 2019-03
• Results First Submitted: 2019-03-29
• Results First Submitted QC: 2019-03-29
• Last Update Submitted: 2019-03-29
• Results First Posted: 2019-04-23
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Sham	Sham treatment (control) in the study eye, administered by intravitreal injections using a needleless drug delivery system (DDS) applicator every 3 months from Baseline (Day 1) through Month 21.
400 µg Brimonidine Implant	400 µg Brimonidine Implant	400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at Month 24	Baseline (Day 1) to Month 24	GA lesion area was measured in mm\^2 by FAF in the study eye and was quantified by the central reading center. The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard Best Correct Visual Acuity (BCVA). If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression). Mixed model for repeated measures (MMRM) was used for analysis.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Month 24	Baseline (Day 1) to Month 24	BCVA was measured using an eye chart (ETDRS) and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard BCVA. If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. MMRM was used for analysis.
Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24	Baseline (Day 1) to Month 24	Low Luminance BCVA was measured by placing a 2.0 log unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard BCVA. If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. MMRM was used for analysis.

Trial Locations

Locations (40)

Retinal Consultants of Arizona, Ltd., Retinal Research Institute; 🇺🇸 Phoenix, Arizona, United States

Associated Retina Consultants; 🇺🇸 Phoenix, Arizona, United States

University of California, San Diego, Jacobs Retina Center, Shiley Eye Center; 🇺🇸 La Jolla, California, United States

Northern California Retina Vitreous Associates; 🇺🇸 Mountain View, California, United States

Retina Consultants of Southern Colorado, PC; 🇺🇸 Colorado Springs, Colorado, United States

"National Ophthalmic Research Institute Retina Consultants of Southwest Florida"; 🇺🇸 Fort Myers, Florida, United States

Retina Specialty Institute; 🇺🇸 Pensacola, Florida, United States

Retina Vitreous Associates of Florida; 🇺🇸 Saint Petersburg, Florida, United States

Southern Vitreoretinal Associates, PL; 🇺🇸 Tallahassee, Florida, United States

Center for Retina and Macular Disease; 🇺🇸 Winter Haven, Florida, United States

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