Trial Outcomes & Findings for EAGLE: Evaluating Genotypes Using Intravitreal Aflibercept Injection (NCT NCT02689518)
NCT ID: NCT02689518
Last Updated: 2021-03-25
Results Overview
The primary endpoint in the study is the correlation of CFH, HTRA1, VEGFA, C3, TIMP3, APOE, CETP, LIPC, TGFBR1, CFI, and CFB allele frequencies and VEGA expression in lymphoblastoid cell lines with response to intravitreal aflibercept injection treatment, based on anatomic outcomes: Early response (at Month 3) - o On optical coherence tomography(SD-OCT) * Reduction in central retinal thickness by ≥ 50%, OR * Central retinal thickness \<300 um, OR * Absence of retinal fluid Later response (at Month 12) - o On SD-OCT * Reduction in central retinal thickness by ≥ 50%, OR * Central retinal thickness \< 300 um, OR * Absence of retinal fluid Poor response, defined as no reduction of fluid or central retinal thickness at Month 12.
COMPLETED
PHASE4
50 participants
12 Months
2021-03-25
Participant Flow
The record for one participant was lost so we will report on 49/50.
Participant milestones
| Measure |
Treatment - On-Label
On-label intravitreal aflibercept (Eylea) injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks (2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months
Intravitreal aflibercept injection: Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months.
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|---|---|
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Overall Study
STARTED
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49
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Overall Study
COMPLETED
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46
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment - On-Label
On-label intravitreal aflibercept (Eylea) injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks (2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months
Intravitreal aflibercept injection: Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months.
|
|---|---|
|
Overall Study
Withdrawal by Subject
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3
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Baseline Characteristics
EAGLE: Evaluating Genotypes Using Intravitreal Aflibercept Injection
Baseline characteristics by cohort
| Measure |
Treatment - On-Label
n=49 Participants
On-label intravitreal aflibercept (Eylea) injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks (2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months
Intravitreal aflibercept injection: Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
47 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Principal Investigator is no longer associated with the institution. All efforts were exhausted to obtain the data but no data could be found.
The primary endpoint in the study is the correlation of CFH, HTRA1, VEGFA, C3, TIMP3, APOE, CETP, LIPC, TGFBR1, CFI, and CFB allele frequencies and VEGA expression in lymphoblastoid cell lines with response to intravitreal aflibercept injection treatment, based on anatomic outcomes: Early response (at Month 3) - o On optical coherence tomography(SD-OCT) * Reduction in central retinal thickness by ≥ 50%, OR * Central retinal thickness \<300 um, OR * Absence of retinal fluid Later response (at Month 12) - o On SD-OCT * Reduction in central retinal thickness by ≥ 50%, OR * Central retinal thickness \< 300 um, OR * Absence of retinal fluid Poor response, defined as no reduction of fluid or central retinal thickness at Month 12.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Principal Investigator is no longer associated with the institution. All efforts were exhausted to obtain the data but no data could be found.
The secondary endpoints are a correlation of CFH, VEGF, HTRA1, VEGFA, C3, TIMP3, APOE, CETP, LIPC, TGFBR1, CFI, and CFB allele frequencies: With visual outcomes - * Early response, defined as a gain ≥ 0 letters at Month 3 * Later response, defined as a gain ≥ 0 letters at Month 12 * Poor response, defined as loss of visual acuity (gain \<0 letters) at Month 12 With change in characteristics on fluorescein angiography and fundus photography (lesion size, lesion type, etc) With number of injections through Month 12 o Mean number of intravitreal aflibercept injections required through Month 12 will be calculated for the group overall, and separately by response group (early, later, and no response to treatment).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 MonthsPopulation: Principal Investigator is no longer associated with the institution. All efforts were exhausted to obtain the data but no data could be found.
Incidence and severity of ocular and non-ocular adverse events using Aflibercept intravitreal injections will also be evaluated.
Outcome measures
Outcome data not reported
Adverse Events
Treatment - On-Label
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Michael Goldbaum
University of California San Diego
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place