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Not due to safety reasons
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostics | Diagnostic Test | Diagnostics |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging in the study eye
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States | ||
| University Hospital Basel |
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| Label | URL |
|---|---|
| Related Info | View source |
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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/
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
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-Optical Coherence Tomography in assessing changes in retinal sensitivity and anatomy over observation period of 48 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled | All enrolled participants who had geographic atrophy secondary to age-related macular degeneration, signed informed consent for this trial, and met all inclusion criteria and none of the exclusion criteria, for evaluating the usage of microperimetry and Swept Source - Optical Coherence Tomography (SS-OCT) in assessing the natural changes of retinal sensitivity and anatomy in the retina. Each participant was planned to be observed for an observation period of 48 weeks after screening visit. During the observation period, 4 visits were planned to be taken at Week 0, 12, 24, and 48 of the observation period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Enrolled set: This subject set includes all subjects that signed informed consent for this trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled | All enrolled participants who had geographic atrophy secondary to age-related macular degeneration, signed informed consent for this trial, and met all inclusion criteria and none of the exclusion criteria, for evaluating the usage of microperimetry and Swept Source - Optical Coherence Tomography (SS-OCT) in assessing the natural changes of retinal sensitivity and anatomy in the retina. Each participant was planned to be observed for an observation period of 48 weeks after screening visit. During the observation period, 4 visits were planned to be taken at Week 0, 12, 24, and 48 of the observation period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected. | Posted | At baseline and at week 12. |
|
From screening visit 1 until early termination of the study, up to 6 month + 5 days.
Enrolled set: This subject set includes all subjects that signed informed consent for this trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Enrolled | All enrolled participants who had geographic atrophy secondary to age-related macular degeneration, signed informed consent for this trial, and met all inclusion criteria and none of the exclusion criteria, for evaluating the usage of microperimetry and Swept Source - Optical Coherence Tomography (SS-OCT) in assessing the natural changes of retinal sensitivity and anatomy in the retina. Each participant was planned to be observed for an observation period of 48 weeks after screening visit. During the observation period, 4 visits were planned to be taken at Week 0, 12, 24, and 48 of the observation period. |
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Study was terminated early by the sponsor. No outcome measures data was collected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2019 | Apr 22, 2021 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000092025 | Rapid Diagnostic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| 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. |
| 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. |
| Number of Scotomatous Points Assessed by Microperimetry at Week 12, 24 and 48 | 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 | At baseline and at week 12, 24 and 48. |
| Basel |
| 4031 |
| Switzerland |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 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 | Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected. | Posted | 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 | Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected. | Posted | 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 | Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected. | Posted | 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 | Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected. | Posted | 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 | Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected. | Posted | 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 | Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected. | Posted | 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 | Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected. | Posted | 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 | Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected. | Posted | At baseline and at week 12, 24 and 48. |
|
|
| Secondary | Number of Scotomatous Points Assessed by Microperimetry at Week 12, 24 and 48 | Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected. | Posted | 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 | Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected. | Posted | At baseline and at week 12, 24 and 48. |
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results.
Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days.
BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D000067716 | Point-of-Care Testing |
| D019095 | Point-of-Care Systems |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |