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| ID | Type | Description | Link |
|---|---|---|---|
| 20122054 | Other Identifier | Western Institutional Review Board |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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To evaluate the visual outcome and number of injections required during an optical coherence tomography (OCT)-guided treat and extend regimen with intravitreal aflibercept for treatment of subfoveal neovascular age-related macular degeneration (NVAMD).
The purpose of this study is to see how using "treat and extend," a method of determining how often a patient with NVAMD should visit the retina clinic and receive treatments, affects vision in patients with this condition after treatment. The treatment the investigators are using in this study is an eye injection of a drug called aflibercept (also called EYLEA). Eylea is FDA (Food and Drug Administration) approved for treatment of wet age related macular degeneration.
The investigators hope that "treat and extend" strikes the right balance between making sure patients get all of the treatments needed, but not giving patients too many treatments (so that the side effects of treatments are minimized and so that patients don't have to make more visits than they need to maintain maximum visual gain). The experimental part of this study is determining this "right balance" of eye injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal Aflibercept Injection More | Experimental | Patient receives treatment at baseline and week 4 visit. The first time extension criteria are met the follow-up interval will be increased by 4 weeks. Each time the extension criteria is met the interval will be extended by 2 weeks to a maximum of 16 weeks. If a patient is being followed at an 8 week interval but fails to meet extension criteria at a particular visit, treatment will be administered as usual and the follow up interval will be reduced to 4 weeks. If patient is being followed at 10-16 week interval but fails to meet extension criteria at a particular visit, treatment will be administered but the follow-up interval will be reduced by 2 week increments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal Aflibercept Injection | Drug | Increased or decreased time between visits |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score | Baseline to Week 52 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Thickness at the Foveal Center Point on OCT | Baseline to Week 52 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl Regillo, MD | Wills Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mid Atlantic Retina- Cherry Hill | Cherry Hill | New Jersey | 08002 | United States | ||
| Mid Atlantic Retina- Huntingdon Valley |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravitreal Aflibercept | Intravitreal aflibercept on treat and extend schedule |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravitreal Aflibercept | Intravitreal aflibercept on treat and extend schedule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score | Posted | Mean | 95% Confidence Interval | letters | Baseline to Week 52 |
|
|
2 years
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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 | Intravitreal aflibercept on treat and extend schedule |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatal MI | Cardiac disorders | Systematic Assessment |
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This is a non-controlled, non-comparative open label study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michele Formoso | Mid Atlantic Retina | 215-928-3092 | research@midatlanticretina.com |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D006009 | Glycogen Storage Disease Type II |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020140 | Lysosomal Storage Diseases, Nervous System |
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| Huntingdon Valley |
| Pennsylvania |
| 19006 |
| United States |
| Mid Atlantic Retina- Wills Eye Institute | Philadelphia | Pennsylvania | 19107 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Other Pre-specified | Change in Total Thickness at the Foveal Center Point on OCT | Posted | Mean | 95% Confidence Interval | micrometers | Baseline to Week 52 |
|
|
|
| 2 |
| 40 |
| 2 |
| 40 |
| 0 |
| 40 |
| Endophthalmitis | Eye disorders | Systematic Assessment |
|
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| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006008 | Glycogen Storage Disease |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D016464 | Lysosomal Storage Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |