Treat and Extend Therapy Using Intravitreal Aflibercept (IAI) for Previously Treated Patients Exiting the Wet Age-related Macular Degeneration Extension Study (0910)

Palmetto Retina Center, LLC6 sites in 1 country45 target enrollmentOctober 2013

ConditionsExudative Age-related Macular Degeneration

InterventionsAflibercept

DrugsAflibercept

Overview

Phase: Phase 4
Intervention: Aflibercept
Conditions: Exudative Age-related Macular Degeneration
Sponsor: Palmetto Retina Center, LLC
Enrollment: 45
Locations: 6
Primary Endpoint: Portion of patients who maintain vision (loss of < or = 5 letters ETDRS BCVA) from baseline to Year 1.
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research study is to determine if a "Treat and Extend" regimen (increasing the time between visits when the disease is stable and not getting worse) of aflibercept 2.0mg injections inside the eye for treating patients with Wet Age-related Macular Degeneration.

Detailed Description

After exiting VGFT-OD 0910, patients will be enrolled into RANGE, a longterm extension trial evaluating the safety and efficacy of aflibercept IAI utilizing a "treat and extend" regimen. Using pre-specified re-treatment criteria, treatment intervals will be variable with dosing of the active treatment at least every 12 weeks.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

July 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Palmetto Retina Center, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Previous enrollment in 0910-extension study evaluating intravitreal aflibercept injection (NCT 00964795) without early study discontinuation prior to sponsor early termination.
•Patients are enrolled within 90 days of site activation (all attempts will be made to ensure IAI is given once exited from the 0910-extension and prior to enrollment).
•Willing and able to comply with clinical 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
•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 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 study period
•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
•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