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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of intravitreal aflibercept injection in a population of neovascular AMD patients that have been previously treated with 2.0 mg ranibizumab for persistent PEDs.
A Phase 4 study to evaluate the efficacy and safety of intravitreal aflibercept injection in a population of neovascular AMD patients that have been previously treated with 2.0 mg ranibizumab for persistent PEDs (the ROLL study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 loading doses, then every 2 months | Experimental | All patients will receive 3 monthly intravitreal aflibercept injections followed by mandatory dosing every 3 months. If needed, patients can be treated monthly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | Intravitreal Injection 2mg/0.05mL Aflibercept |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with flattening of PED | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Best Corrected Visual Acuity (BCVA) | 6 month timepoint and 12 month timepoints | |
| Proportion of patients with flattening of PED | 6 months | |
| Proportion of patients with flattening of PED |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | 24 month period |
Inclusion Criteria:
Previous enrollment in the study evaluating 2.0mg ranibizumab (NCT 01189019) without early study discontinuation. The last treatment* in the study eye should have been received at least 30 days before enrollment in this study.
**last study treatment of either 1.0mg or 2.0mg ranibizumab
Presence of persistent fibrovascular pigment epithelial detachment Willing and able to comply iwth clinic visits and study related procedures Provide signed informed consent
Exclusion Criteria:
Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye.
History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye.
Concurrent eye disease in the study eye that could compromise visual acuity (e.g. diabetic retinopathy, advanced glaucoma).
Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy or glaucoma) that, in the opinion of the investigator, could either require medical or surgical intervention during the 12 month study period to prevent or treat visual loss that might result from that condition, or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 12 month study period.
Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or auto-immune associated uveitis in either eye.
Current vitreous hemorrhage in the study eye.
History of rhegmatogenous retinal detachment or macular hole (stage 3 or 4) in the study eye.
Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
Aphakia, anterior chamber intraocular lens (ACIOL) or unstable posterior chamber intraocular lens (PCIOL).
Uncontrolled glaucoma in the study eye (defined as intraocular pressure equal to or greater than 30 despite treatment with anti-glaucoma medication).
Pregnant or breastfeeding women.
Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraception measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); 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 |
|---|---|---|
| Brandon G Busbee, MD | Tennessee Retina, PC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Eye Associates | San Francisco | California | 94115 | United States | ||
| Retina Associates of Kentucky |
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| 18 month and 24 month timepoints |
| Mean number of injections needed | 12 month period |
| Mean change in Optical Coherence Tomography (OCT) central retinal thickness | 6 month and 12 month timepoints |
| Proportion of patients gaining 5 letters or more letters on Early Treatment Diabetic Retinopathy Study (ETDRS) Chart | 6 month and 12 month timepoint |
| Mean change in BCVA | 18 month and 24 month timepoint |
| Mean number of injections | during year 2 |
| Mean change in OCT central retinal thickness | 18 month and 24 month timepoints |
| Proportion of patients gaining 5 letters or more | 18 month and 24 month timepoints |
| Lexington |
| Kentucky |
| 40509 |
| United States |
| Tennessee Retina, P.C. | Nashville | Tennessee | 37203 | United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012163 | Retinal Detachment |
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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