Global Atrophie Biomarker Evaluation Study (GABiE)

Stopped early

Conditions studied: Age-related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT03935126

Run by

Boehringer Ingelheim

People needed

3

Starts

2019-05-07

Expected to finish

2020-05-14

Last updated by the study team

2021-05-21

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States
• University Hospital Basel — Basel, Switzerland

Full record on ClinicalTrials.gov

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