Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration (BEACON Study)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 320

Inclusion Criteria

• Male or female patients 55 years of age or older as assessed at Screening Visit 1
• Diagnosis of non-central GA secondary to AMD as assessed with fundus autofluorescence (FAF) at Screening Visit 1 and confirmed by the central reading center (CRC); these atrophic areas consist of funduscopically visible discrete areas characterized by a marked decrease in fundus autofluorescence intensity and loss of outer-retinal layers with choroidal signal enhancement as assessed with SD-OCT. Areas of atrophy must be multifocal lesions that contain all of the following
characteristics:
- Located outside a 300 micron radius from the center point of the fovea (ie, noncentral
atrophic lesions)
- At least one focal lesion must be equal to or larger than 0.3 mm2
- The total lesion area must be greater than 1.25 mm2, but not larger than 12.5 mm2
- Lesions must occupy 50% or less of the area of the retina between a 0.5 mm radius
and a 1.5 mm radius from the foveal center point (lesions that occupy more than 50%
of this area will limit the area available for retinal sensitivity assessment)
- The presence of banded or diffuse perilesional hyper-autofluorescence evident on
fundus autofluorescence examination.
- The distance between the optic disc or peripapillary atrophy and any atrophic lesion
must be greater than 500 µm
• The Study Eye must have:
- Presence of reticular drusen (also known as reticular pseudodrusen, subretinal drusenoid
deposits, reticular macular disease); a minimum of 5 individual lesions assessed with near
infrared reflectance (macular IR-image acquired with the SD-OCT scan); based on images collected at Screening Visit 1 and
confirmed by the CRC
- BCVA better than or equal to 59 letters (20/62 Snellen equivalent) at Screening Visit 1, Screening Visit 2
and the Baseline visit as assessed using the standard ETDRS (Early Treatment of
Diabetic Retinopathy Study) visual acuity protocol
- Ability to complete repeat assessments of scotopic microperimetry with an intra-visit,
mean, retinal sensitivity reproducibility of 3 dB or less, as assessed at Screening Visit 2
- Clear ocular media and adequate pupil dilation to permit good quality retinal imaging as
assessed at Screening Visit 1 and confirmed by the CRC
• The Fellow Eye must have Standard BCVA of 34 letters (Snellen equivalent 20/200) or better at Screening Visit 1

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

Exclusion Criteria

• History or evidence of choroidal neovascularization in either eye at Screening Visit 1
• Diagnosis of central GA, unifocal atrophic lesions, or lesions with no perilesional hyperautofluorescence,
or with only focal areas of perilesional hyper-autofluorescence on FAF examination of the study eye at Screening Visit 1
• Spherical equivalent of the refractive error of -6 diopters of myopia or worse (prior to cataract
or refractive surgery) in the study eye at Screening Visit 1

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study objectives are to assess: (1) the safety of the treatment; (2) the effects of treatment<br>on the mean change in atrophic lesion area quantified from fundus autofluorescence images;<br>(3) the effects of treatment on the mean change in retinal sensitivity quantified using scotopic<br>microperimetry; (4) the effects of treatment on the mean change in low luminance BCVA;<br>(5) the effects of treatment on the mean change in standard BCVA<br>(6) to characterize the systemic pharmacokinetic profile of Brimo DDS.;Secondary Objective: None. ;Primary end point(s): Atrophic lesion area as assessed with fundus autofluorescence and quantified by the<br>CRC;Timepoint(s) of evaluation of this end point: 24 months following the first treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Retinal sensitivity as assessed with scotopic microperimetry<br>• Low luminance BCVA as assessed using a 2.0 log unit neutral density filter and the<br>ETDRS visual acuity protocol<br>• Standard BCVA assessed using the ETDRS visual acuity protocol;Timepoint(s) of evaluation of this end point: 24 months following the first treatment.

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