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: Not specified

Target Recruitment: 310

Inclusion Criteria

• Male or female patients 55 years of age or older as assessed at Screening Visit 1
The study eye must have:
• Diagnosis of 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:
- At least one focal lesion must be equal to or larger than 0.2 mm2
- The total lesion area must be greater than 1.25 mm2, but not larger than 18 mm2
- 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 300 µm
• Presence of drusen, yellow or white accumulations of extracellular material formed between Bruch's membrane and the retina pigmented epithelial cell layer, assessed with fundus photography and/or SD-OCT at Screening Visit 1 and confirmed by the CRC
- BCVA better than or equal to 45 letters (20/125 Snellen equivalent) at Screening Visit 1 and the Baseline visit as assessed using the standard ETDRS (Early Treatment of Diabetic Retinopathy Study) visual acuity protocol
- Clear ocular media and adequate pupil dilation to permit good quality retinal imaging as assessed at Screening Visit 1 and confirmed by the CRC
- For patients participating in microperimetry assessments: abitity to complete repeat assessments of scotopic/mesopic microperimetry with an intra-visit, mean, retinal sensitivity reproducibility of 6 dB or less, as assessed at Screening Visit 2 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, as confirmed by the CRC
• Diagnosis of GA secondary to AMD that presents as unifocal atrophic lesions, lesions with no perilesional hyper-autofluorescence, lesions with only focal areas of perilesional hyper-autofluorescence on FAF examination of the study eye at Screening Visit 1 and confirmed by the CRC
• 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
Secondary Objective: None. ;<br> Primary end point(s): Atrophic lesion area as assessed with fundus autofluorescence and quantified by the<br> CRC<br> ;Timepoint(s) of evaluation of this end point: 24 months following the first treatment. ;<br> 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 low luminance best corrected visual acuity (BCVA);<br> (4) the effects of treatment on the mean change in standard BCVA;<br> (5) the effects of treatment on the mean change in retinal sensitivity quatified using scotopic/mesopic microperimetry;<br> (6) to characterize the systemic pharmacokinetic profile of Brimo DDS.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): • Retinal sensitivity as assessed with scotopic/mesopic 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<br> ;Timepoint(s) of evaluation of this end point: 24 months following the first treatment.

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