On-label tReatment With Intravitreal Aflibercept injectiOn for Patients With Persistent Pigment e… (NCT01670162) | Clinical Trial Compass
UnknownPhase 4
On-label tReatment With Intravitreal Aflibercept injectiOn for Patients With Persistent Pigment epitheliaL Detachments in Neovascular Age Related Macular Degeneration (AMD)
United States30 participantsStarted 2012-08
Plain-language summary
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.
Who can participate
Age range50 Years
SexALL
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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:
* Prior treatment with verteporfin, or external beam radiation therapy, or transpupillary thermotherapy in the study eye.
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 ey…