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Site investigator decided to not move forward with study.
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The purpose of this study is to determine the efficacy of intravitreal aflibercept injections administered in a treat and extend fashion in eyes that have persistent center involved diabetic macular edema following at least 4 intravitreal injections of 0.3 mg ranibizumab over 24 weeks.
This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial to determine the efficacy of intravitreal aflibercept (IAI) administered in a treat and extend fashion in eyes that have persistent centered involved diabetic macular edema despite at least 4 intravitreal injections of ranibizumab 0.3mg over 24 weeks prior to enrollment. Patients will receive intravitreal injections of aflibercept (2mg/0.05cc) at baseline and monthly until an eye has reached stability defined as: < 10% change in the Spectral Domain Optical Coherence Tomography (SD OCT) central retinal thickness (CRT) reading from the previous 2 visits (can include baseline) and less than a 5 letter decrease in Best Corrected Visual Acuity (BCVA) from best BCVA from prior visits. Once an eye has reached stability criteria, a treat and extend protocol will be used and treatment will be rendered on every visit. The duration between treatments will be extended by 2 weeks from the last visit if SD OCT extension criteria are met: < 10% change in CRT over 2 consecutive visits and < 5 letter decrease in BCVA from baseline
If at any return visit subretinal and/or intraretinal fluid recurs that causes the CRT to increase by > 10 % from its lowest level in the previous 2 consecutive visits, or CRT increases by < 10% due to subretinal and/or intraretinal fluid but is associated with a decrease of BCVA of > 5 letters from baseline then the eye will receive IAI and the treatment interval will be decreased by 1 week. If the eye has not improved or worsened for at least 2 consecutive visits and the SD OCT central subfield thickness is ≥ 300 microns or visual acuity is worse than 20/20, the following will be done:
Prior to the 24-week visit, an injection will be given. At and after the 24-week visit, an injection will be given and modified grid laser can be given at the discretion of the investigator within 7 days of IAI based on rescue criteria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal Aflibercept | Experimental | Intravitreal Aflibercept Injection (IAI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal Aflibercept | Drug | Intravitreal Aflibercept 2mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Central Subfield Thickness (CST) | Percentage of patients who experience a > 10% decrease in mean Central Subfield Thickness (CST) from baseline or whose CST < 300 microns at 52 weeks. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Visual Acuity | Mean change in Best Corrected Visual Acuity | 52 weeks |
| Change in Central Subfield Thickness (CST) | Mean change in CST on SD OCT compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew N Antoszyk, MD | Charlotte Eye Ear Nose and Throat Assciates, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charlotte Eye Ear Nose and Throat Associates, PA | Charlotte | North Carolina | 28210 | United States | ||
| Charlotte Eye Ear Nose and Throat Associates, PA |
Site will not be sharing IPD.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 52 weeks |
| Number of Intravitreal Injections | Mean number of injections from baseline | 52 Weeks |
| Statesville |
| North Carolina |
| 28677 |
| United States |