Trial Outcomes & Findings for To Evaluate The Role of Intravitreal Aflibercept Injection (2.0 mg) in the Management of Previously Treated Patients With Exudative AMD (NCT NCT01495221)
NCT ID: NCT01495221
Last Updated: 2018-09-07
Results Overview
No primary outcome data can be found or provided.
COMPLETED
PHASE4
9 participants
24 week
2018-09-07
Participant Flow
Participant milestones
| Measure |
Intravitreal Aflibercept
All eligible patients will receive intravitreal aflibercept injection (2.0mg) every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months) through Week 24. Patients can be dosed as frequently as 2 mg every 4 weeks (monthly) upon investigator discretion.
Alfilbercept: All patients will receive 2.0 mg intravitreal aflibercept injection.
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|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Evaluate The Role of Intravitreal Aflibercept Injection (2.0 mg) in the Management of Previously Treated Patients With Exudative AMD
Baseline characteristics by cohort
| Measure |
Intravitreal Aflibercept
n=9 Participants
All eligible patients will receive intravitreal aflibercept injection (2.0mg) every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months) through Week 24. Patients can be dosed as frequently as 2 mg every 4 weeks (monthly) upon investigator discretion.
Alfilbercept: All patients will receive 2.0 mg intravitreal aflibercept injection.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
74 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
|
First Prescription for Choroidial NeoVascularization
|
18.5 Months
n=5 Participants
|
|
EDTRS Visual Acuity Score
|
63 Letters
n=5 Participants
|
|
Lesion Type: ( Fluroscien Angiogram and
Occult CNV with PCV features
|
3 Participants
n=5 Participants
|
|
Lesion Type: ( Fluroscien Angiogram and
Occult CNV with CSC features
|
2 Participants
n=5 Participants
|
|
Lesion Type: ( Fluroscien Angiogram and
Occult CNV only
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weekPopulation: Patients analyzed is zero due to no outcome data was collected at week 24 due to early termination of the clinical study.
No primary outcome data can be found or provided.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline to Week 16Population: The average age of enrollment is 74 years old with first treatment for CNV at 18.5 months.
Visual acuity was documented via BCVA at every study visit.
Outcome measures
| Measure |
Intravitreal Aflibercept
n=9 Participants
All eligible patients will receive intravitreal aflibercept injection (2.0mg) every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months) through Week 24. Patients can be dosed as frequently as 2 mg every 4 weeks (monthly) upon investigator discretion.
Alfilbercept: All patients will receive 2.0 mg intravitreal aflibercept injection.
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|---|---|
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Mean Change in Visual Acuity From Baseline to Week 16
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4.2 letters
Standard Deviation 6.3
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SECONDARY outcome
Timeframe: Baseline and week 16Population: The average age of enrollment is 74 years old with first treatment for CNV at 18.5 months.
OCT is performed on the Spectralis spectral domain OCT machine (Heidelberg Engineering, Germany). The OCT is centered on the fovea. The OCT examination will use the 19 scan mode on the Spectralis averaging at least 25 images per scan. Follow-up visits will use the follow-up protocol on the Spectralis , automatically placing follow-up scans in precisely the same location as the baseline scan.
Outcome measures
| Measure |
Intravitreal Aflibercept
n=9 Participants
All eligible patients will receive intravitreal aflibercept injection (2.0mg) every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months) through Week 24. Patients can be dosed as frequently as 2 mg every 4 weeks (monthly) upon investigator discretion.
Alfilbercept: All patients will receive 2.0 mg intravitreal aflibercept injection.
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|---|---|
|
Mean Change in OCT Central Retinal Lesion Thickness From Baseline to Week 16
|
-45 Microns
Interval -237.0 to 237.0
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SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: The average age of enrollment is 74 years old with first treatment for CNV at 18.5 months.
OCT is performed on the Spectralis spectral domain OCT machine (Heidelberg Engineering, Germany). The OCT is centered on the fovea. The OCT examination will use the 19 scan mode on the Spectralis averaging at least 25 images per scan. Follow-up visits will use the follow-up protocol on the Spectralis , automatically placing follow-up scans in precisely the same location as the baseline scan.
Outcome measures
| Measure |
Intravitreal Aflibercept
n=9 Participants
All eligible patients will receive intravitreal aflibercept injection (2.0mg) every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months) through Week 24. Patients can be dosed as frequently as 2 mg every 4 weeks (monthly) upon investigator discretion.
Alfilbercept: All patients will receive 2.0 mg intravitreal aflibercept injection.
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|---|---|
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Mean Change in OCT Greatest Height of Pigment Epithelial Detachment From Baseline to Week 16
|
-90 microns
Interval -331.0 to 331.0
|
Adverse Events
Intravitreal Aflibercept
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intravitreal Aflibercept
n=9 participants at risk
All eligible patients will receive intravitreal aflibercept injection (2.0mg) every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months) through Week 24. Patients can be dosed as frequently as 2 mg every 4 weeks (monthly) upon investigator discretion.
Alfilbercept: All patients will receive 2.0 mg intravitreal aflibercept injection.
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|---|---|
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Musculoskeletal and connective tissue disorders
Left thigh muscle tear and hematoma
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Dog bite to lower left leg
|
11.1%
1/9
|
|
General disorders
Unknown Event
|
11.1%
1/9
|
Additional Information
Jason S. Slakter, MD
Vitreous Retina Macula Consulatants of New York
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place