Global Atrophie Biomarker Evaluation Study (GABiE)

NCT03935126 | Terminated Results

• 1 other identifier: 0352-2110
• Study Type: observational
• Target: 3
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (8)

• 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.

• 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.

• 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.

• 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

• 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.

Study Arms (1)

All patients

Diagnostic Test: Diagnostics

Interventions

Diagnostics DIAGNOSTIC_TEST

Diagnostics

All patients

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD) who are not receiving treatment for GA and have not previously receiving active treatment in clinical trials in the indication under invesitigation will be enrolled and followed for up to 12 months.

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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Links

• Related Info

MeSH Terms

Conditions

Macular Degeneration

Interventions

Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Limitations and Caveats

Study was terminated early by the sponsor. No outcome measures data was collected.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 2, 2019
• Study Start: May 7, 2019
• Primary Completion: May 6, 2020
• Study Completion: May 14, 2020
• Last Updated: May 21, 2021
• Results First Posted: May 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CH (1)