On-label tReatment With Intravitreal Aflibercept Injection for Patients With Persistent Pigment Epithelial Detachments in Neovascular AMD.

Tennessee Retina3 sites in 1 country30 target enrollmentAugust 2012

ConditionsAge Related Macular Degeneration Pigment Epithelial Detachment

InterventionsAflibercept

DrugsAflibercept

Overview

Phase: Phase 4
Intervention: Aflibercept
Conditions: Age Related Macular Degeneration
Sponsor: Tennessee Retina
Enrollment: 30
Locations: 3
Primary Endpoint: Proportion of patients with flattening of PED
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

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).

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

January 2016

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tennessee Retina

Responsible Party

Sponsor

Eligibility Criteria

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 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).

Arms & Interventions

3 loading doses, then every 2 months

All patients will receive 3 monthly intravitreal aflibercept injections followed by mandatory dosing every 3 months. If needed, patients can be treated monthly.

Intervention: Aflibercept

Outcomes

Primary Outcomes

Proportion of patients with flattening of PED

Time Frame: 12 months

Secondary Outcomes

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)
Mean Change in Best Corrected Visual Acuity (BCVA)(6 month timepoint and 12 month timepoints)
Proportion of patients with flattening of PED(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)