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出境医 / 临床实验 / Global Atrophie Biomarker Evaluation Study (GABiE) (GABiE)

Global Atrophie Biomarker Evaluation Study (GABiE) (GABiE)

Study Description
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.

Condition or disease Intervention/treatment
Age-related Macular Degeneration Diagnostic Test: Diagnostics

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : May 7, 2019
Actual Primary Completion Date : May 6, 2020
Actual Study Completion Date : May 14, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
All patients Diagnostic Test: Diagnostics
Diagnostics

Outcome Measures
Primary Outcome Measures :
  1. 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: At baseline and at week 12. ]
  2. 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 [ Time Frame: At baseline and at week 12. ]
  3. 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 [ Time Frame: At baseline and at week 12. ]

Secondary Outcome Measures :
  1. 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: At baseline and at week 24 and 48. ]
  2. 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 [ Time Frame: At baseline and at week 24 and 48. ]
  3. 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 [ Time Frame: At baseline and at week 24 and 48. ]
  4. Change From Baseline in the GA Area as Measured by Fundus Autofluorescence (FAF) at Week 12, 24 and 48 [ Time Frame: At baseline and at week 12, 24 and 48 ]
  5. 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 [ Time Frame: At baseline and at week 12, 24 and 48. ]
  6. 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 [ Time Frame: At baseline and at week 12, 24 and 48. ]
  7. Number of Scotomatous Points Assessed by Microperimetry at Week 12, 24 and 48 [ Time Frame: At week 12, 24 and 48 ]
  8. 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: At baseline and at week 12, 24 and 48. ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations

Locations
Layout table for location information
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
Boehringer Ingelheim
Tracking Information
First Submitted Date April 30, 2019
First Posted Date May 2, 2019
Results First Submitted Date April 29, 2021
Results First Posted Date May 21, 2021
Last Update Posted Date May 21, 2021
Actual Study Start Date May 7, 2019
Actual Primary Completion Date May 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2021)
  • 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: 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 [ Time Frame: 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 [ Time Frame: At baseline and at week 12. ]
Original Primary Outcome Measures
 (submitted: April 30, 2019)
  • 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 ]
Change History
Current Secondary Outcome Measures
 (submitted: January 22, 2021)
  • 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: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At baseline and at week 12, 24 and 48. ]
  • 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 [ Time Frame: At baseline and at week 12, 24 and 48. ]
  • Number of Scotomatous Points Assessed by Microperimetry at Week 12, 24 and 48 [ Time Frame: At week 12, 24 and 48 ]
  • 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: At baseline and at week 12, 24 and 48. ]
Original Secondary Outcome Measures
 (submitted: April 30, 2019)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Global Atrophie Biomarker Evaluation Study (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.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Age-related Macular Degeneration
Intervention Diagnostic Test: Diagnostics
Diagnostics
Study Groups/Cohorts All patients
Intervention: Diagnostic Test: Diagnostics
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: May 26, 2020)
3
Original Estimated Enrollment
 (submitted: April 30, 2019)
50
Actual Study Completion Date May 14, 2020
Actual Primary Completion Date May 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number NCT03935126
Other Study ID Numbers 0352-2110
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: http://trials.boehringer-ingelheim.com/

Responsible Party Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Not Provided
Investigators Not Provided
PRS Account Boehringer Ingelheim
Verification Date April 2021

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