Condition or disease | Intervention/treatment |
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Age-related Macular Degeneration | Diagnostic Test: Diagnostics |
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 |
Group/Cohort | Intervention/treatment |
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All patients |
Diagnostic Test: Diagnostics
Diagnostics
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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 |
Inclusion Criteria:
Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active CNV in the study eye
Exclusion Criteria:
United States, Massachusetts | |
Tufts Medical Center | |
Boston, Massachusetts, United States, 02111 | |
Switzerland | |
University Hospital Basel | |
Basel, Switzerland, 4031 |
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures |
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Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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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 |
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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
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Study Groups/Cohorts | All patients
Intervention: Diagnostic Test: Diagnostics
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Terminated | ||||
Actual Enrollment |
3 | ||||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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Responsible Party | Boehringer Ingelheim | ||||
Study Sponsor | Boehringer Ingelheim | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Boehringer Ingelheim | ||||
Verification Date | April 2021 |