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This is an open label study to evaluate intravitreally administered 2.0 mg intravitreal aflibercept injection in patients who have been previously treated for AMD and have persistent or recurrent fluid despite monthly intravitreal anti-VEGF therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal aflibercept | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alfilbercept | Drug | All patients will receive 2.0 mg intravitreal aflibercept injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With no Fluid on OCT at Week 24 | No primary outcome data can be found or provided. | 24 week |
| Mean Change in Visual Acuity From Baseline to Week 16 | Visual acuity was documented via BCVA at every study visit. | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in OCT Central Retinal Lesion Thickness From Baseline to Week 16 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitreous Retina Macula Consultants of New York | New York | New York | 10022 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline and week 16 |
| Mean Change in OCT Greatest Height of Pigment Epithelial Detachment From Baseline to Week 16 | 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. | Baseline and 16 weeks |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| First Prescription for Choroidial NeoVascularization | Mean | Full Range | Months |
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| EDTRS Visual Acuity Score | Mean | Full Range | Letters |
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| Lesion Type: ( Fluroscien Angiogram and | Count of Participants | Participants |
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| 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 | Proportion of Patients With no Fluid on OCT at Week 24 | No primary outcome data can be found or provided. | Patients analyzed is zero due to no outcome data was collected at week 24 due to early termination of the clinical study. | Posted | 24 week |
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| Primary | Mean Change in Visual Acuity From Baseline to Week 16 | Visual acuity was documented via BCVA at every study visit. | The average age of enrollment is 74 years old with first treatment for CNV at 18.5 months. | Posted | Mean | Standard Deviation | letters | Baseline to Week 16 |
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| Secondary | Mean Change in OCT Central Retinal Lesion Thickness From Baseline to Week 16 | 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. | The average age of enrollment is 74 years old with first treatment for CNV at 18.5 months. | Posted | Mean | Full Range | Microns | Baseline and week 16 |
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| Secondary | Mean Change in OCT Greatest Height of Pigment Epithelial Detachment From Baseline to Week 16 | 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. | The average age of enrollment is 74 years old with first treatment for CNV at 18.5 months. | Posted | Mean | Full Range | microns | Baseline and 16 weeks |
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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 | 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. | 0 | 9 | 0 | 9 | 3 | 9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left thigh muscle tear and hematoma | Musculoskeletal and connective tissue disorders | Not related to treatment |
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| Dog bite to lower left leg | Musculoskeletal and connective tissue disorders | Not related to treatment |
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| Unknown Event | General disorders | Specific event not documented on patient sheet. Not related to treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason S. Slakter, MD | Vitreous Retina Macula Consulatants of New York | 212-861-9797 | mail@vrmny.com |
| Occult CNV only |
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