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| ID | Type | Description | Link |
|---|---|---|---|
| VGFT-OD-1313 | Other Identifier | Regeneron Pharmaceuticals |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The purpose of this study is determine the number of patients with complete resolution of macular edema secondary to central retinal vein occlusion following 6 monthly injections of Aflibercept.
Twenty (20) consented participant who meet the inclusion criteria will be enrolled to be followed for 6 months. All subjects will receive monthly 2.0 mg intravitreal aflibercept injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept 2.0mg | Experimental | Single arm - Intravitreal Aflibercept 2.0mg, 0.05 milliliters, monthly for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | Monthly 2.0mg Aflibercept Intravitreal Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete anatomic resolution of macular edema following central retinal vein occlusion (CRVO) as measured by Optical Coherence Tomography (OCT) | From baseline to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of reduction in macular thickness | Month 6 | |
| Extent of reduction in macular volume | Month 6 | |
| Mean change in best-corrected visual acuity (BCVA) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on macular leakage using fluorescein angiogram (FA) | Month 6 | |
| Effect on peripheral retinal non-perfusion | Month 6 |
Inclusion Criteria:A patient must meet the following criteria to be eligible for inclusion in the study:
Age >18 years
Documented macular edema following central retinal vein occlusion
Currently receiving treatment with intravitreal anti-VEGF therapy initiated at least 3 months months previously
Documented intravitreal treatment with ranibizumab 0.5 mg (at least 3 doses, each one month apart) or bevacizumab 1.25 mg (at least 3 doses, each one month apart)
Presence of persistent macular edema (defined as any of the following):
Willingness and ability to comply with clinic visits and study-related procedures
Ability to provide signed informed consent
Exclusion Criteria:
Prior vitrectomy in the study eye
Concurrent retinal vascular disease in the study eye that could compromise visual acuity or contribute to macular edema (e.g. diabetic retinopathy, age-related macular degeneration)
Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy, advanced glaucoma) that, in the opinion of the investigator, could either
Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye
Current vitreous hemorrhage in the study eye
Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
Intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline
Systemic anti-VEGF treatment within the last 3 months prior to screening
Prior intravitreal aflibercept injection in the study eye
Macular laser photocoagulation within 4 months of screening
Intravitreal or periocular corticosteroid within 4 months of screening
Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with ocular antihypertensive medication)
Allergy to fluorescein, povidone iodine (Betadine) or aflibercept
Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study
Patients with cognitive dysfunction such as dementia, Alzheimer's disease or any other neuro-degenerative disorder.
Pregnant or breast-feeding women
Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
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| Name | Affiliation | Role |
|---|---|---|
| Franco M Recchia, MD | Tennessee Retina, PC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Retina, PC | Nashville | Tennessee | 37203 | United States |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Month 6 |
| Proportion of patients with gain or loss of 5, 10, and 15 letters in BCVA | Month 6 |
| Number and severity of adverse events | 6 month-period |
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |