Trial Outcomes & Findings for Global Atrophie Biomarker Evaluation Study (GABiE) (NCT NCT03935126)
NCT ID: NCT03935126
Last Updated: 2021-05-21
Results Overview
TERMINATED
3 participants
At baseline and at week 12.
2021-05-21
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Study termination by sponsor
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3
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Baseline Characteristics
Global Atrophie Biomarker Evaluation Study (GABiE)
Baseline characteristics by cohort
| Measure |
All Enrolled
n=3 Participants
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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|---|---|
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Age, Continuous
|
83.7 Years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline and at week 12.Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At baseline and at week 12.Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At baseline and at week 12.Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and at week 24 and 48.Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and at week 24 and 48.Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and at week 24 and 48.Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and at week 12, 24 and 48Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and at week 12, 24 and 48.Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and at week 12, 24 and 48.Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At week 12, 24 and 48Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and at week 12, 24 and 48.Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Outcome measures
Outcome data not reported
Adverse Events
All Enrolled
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER