Global Atrophie Biomarker Evaluation Study (GABiE)

Age-related Macular Degeneration Clinical Trial

— GABiE  

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03935126
• Other study ID #: 0352-2110
• Status: Terminated
• Start date: May 7, 2019
• Est. completion date: May 14, 2020

Study information

• Verified date: April 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 14, 2020
• Est. primary completion date: May 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Atrophy
• Macular Degeneration

Intervention

Diagnostic Test:
• Diagnostics
Diagnostics

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		At baseline and at week 12.
Primary	Change From Baseline in Retinal Pigment Epithelium (RPE) Layer Thickness in the Junctional Zone and in the Perilesional Zone as Measured by Swept Source - Optical Coherence Tomography (SS-OCT) at Week 12		At baseline and at week 12.
Primary	Change From Baseline in Photoreceptor Layer Thickness in the Junctional Zone and in the Perilesional Zone as Measured by Swept Source - Optical Coherence Tomography (SS-OCT) at Week 12		At baseline and at week 12.
Secondary	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		At baseline and at week 24 and 48.
Secondary	Change From Baseline in Retinal Pigment Epithelium (RPE) Layer Thickness in the Junctional Zone and in the Perilesional Zone as Measured by Swept Source - Optical Coherence Tomography (SS-OCT) at Week 24 and 48		At baseline and at week 24 and 48.
Secondary	Change From Baseline in Photoreceptor Layer Thickness in the Junctional Zone and in the Perilesional Zone as Measured by Swept Source - Optical Coherence Tomography (SS-OCT) at Week 24 and 48		At baseline and at week 24 and 48.
Secondary	Change From Baseline in the GA Area as Measured by Fundus Autofluorescence (FAF) at Week 12, 24 and 48		At baseline and at week 12, 24 and 48
Secondary	Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Scale (ETDRS) Chart at a Starting Distance of 4 Meters at Week 12, 24 and 48		At baseline and at week 12, 24 and 48.
Secondary	Change From Baseline in Low Luminance Visual Acuity (LLVA) Score as Assessed by ETDRS Chart Under Low Luminance Conditions at a Starting Distance of 4 Meters at Week 12, 24 and 48		At baseline and at week 12, 24 and 48.
Secondary	Number of Scotomatous Points Assessed by Microperimetry at Week 12, 24 and 48		At week 12, 24 and 48
Secondary	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		At baseline and at week 12, 24 and 48.

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