Global Atrophie Biomarker Evaluation Study (GABiE)

Overview

To investigate the use of microperimetry and SS-OCT in assessing the natural changes of retinal sensitivity and anatomy in the perilesional zone of geographic atrophy areas in patients with dry age-related macular degeneration.

Full Title of Study: “A Biomarker Evaluation Study in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration (AMD) Evaluating the Use of Microperimetry (Fundus-controlled Perimetry) and Swept Source-OCT in Assessing Changes in Retinal Sensitivity and Anatomy Over Time.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 15, 2020

Interventions

  • Diagnostic Test: Diagnostics
    • Diagnostics

Arms, Groups and Cohorts

  • Experimental: All patients

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in retinal sensitivity in the junctional zone and in the perilesional zone of the largest atrophic loci as assessed by microperimetry for the evaluation of macular functional response at week 12
    • Time Frame: 12 weeks
  • Change from baseline in RPE layer thickness in the junctional zone and in the perilesional zone as measured by SS-OCT at week 12
    • Time Frame: 12 weeks
  • Change from baseline in photoreceptor layer thickness in the junctional zone and in the perilesional zone as measured by SS-OCT at week 12
    • Time Frame: 12 weeks

Secondary Measures

  • Change from baseline in retinal sensitivity in the junctional zone and in the perilesional zone of the largest atrophic loci as assessed by microperimetry at week 24 and 48
    • Time Frame: 48 weeks
  • Change from baseline in RPE layer thickness in the junctional zone and in the perilesional zone as measured by SS-OCT at week 24 and 48
    • Time Frame: 48 weeks
  • Change from baseline in photoreceptor layer thickness in the junctional zone and in the perilesional zone as measured by SS-OCT at week 24 and 48
    • Time Frame: 48 weeks
  • Change from baseline in the GA area as measured by Fundus Autofluorescence (FAF) at week 12, 24 and 48
    • Time Frame: 48 weeks
  • Change in Best Corrected Visual Acuity (BCVA) score as assessed by Early Treatment Diabetic Retinopathy Scale (ETDRS) chart at a starting distance of 4 m at week 12, 24 and 48
    • Time Frame: 48 weeks
  • Change in Low Luminance Visual Acuity (LLVA) score as assessed by ETDRS chart under low luminance conditions at a starting distance of 4 m at week 12, 24 and 48
    • Time Frame: 48 weeks
  • Number of scotomatous points assessed by microperimetry at week 12, 24 and 48
    • Time Frame: 48 weeks
  • Change from baseline in the area of choroidal non-perfusion as measured via Optical Coherence Tomography Angiography (OCT-A) at week 12, 24 and 48
    • Time Frame: 48 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the study
  • Age >=60 years
  • Ability (including a sufficient general health status according to investigators judgement) and willingness to undertake all scheduled visits and assessments including predefined methodology and standards utilizing microperimetry GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in the study eye
  • GA lesion in the study eye must reside completely within the FAF imaging field (Field 2- 30 degree image centered on the fovea)
  • BCVA of 20/63 or better (Snellen equivalent) using ETDRS charts at starting distance of 4 m in the study eye
  • Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active CNV in the study eye
  • The total GA lesion size >=1.2 mm^2 (approximately >=0.5 disc area [DA]) and <=17.78 mm^2 (approximately <=7 DA) and must reside completely within the FAF imaging field (Field 2-30 degree image centered on the fovea)
  • If GA is multifocal, at least 1 focal lesion must be >=1.2 mm^2 (approximately >=0.5 DA)
  • Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging in the study eye

Exclusion Criteria

  • GA in either eye due to causes other than AMD (for example, monogenetic macular dystrophies [e.g., Stargardt disease, cone rod dystrophy] or toxic maculopathies [e.g., chloroquine/hydroxychloroquine maculopathy])
  • Receiving active treatment in any studies of investigational drugs for GA/dry AMD in the study eye
  • Mean sensitivity difference > 3 dB between the two microperimetry examinations in the screening visit.
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
  • Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy in the study eye
  • Prior treatment with Visudyne ®, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
  • History of prophylactic subthreshold laser treatment for AMD in the study eye
  • Further criteria apply.

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

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