Overview

This trial is active, not recruiting.

Condition exudative age-related macular degeneration
Treatment aflibercept
Phase phase 4
Target VEGF
Sponsor Palmetto Retina Center, LLC
Start date October 2013
End date March 2016
Trial size 45 participants
Trial identifier NCT01961414, VGFT-OD-1319

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All patients will receive aflibercept 2.0mg intravitreal injection
aflibercept Eylea 2.0mg, VEGF TRAP-EYE
Patients will receive Aflibercept 2.0mg intravitreal injection at all scheduled study visits

Primary Outcomes

Measure
Portion of patients who maintain vision (loss of < or = 5 letters ETDRS BCVA) from baseline to Year 1.
time frame: 1 Year

Eligibility Criteria

Male or female participants of any age.

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 - Aphakia, ACIOL, or unstable PCIOL - Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication) - 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 [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly) - Contraception is not required for men with documented vasectomy. - Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Additional Information

Official title Treat and Extend Therapy Using Intravitreal Aflibercept (IAI) for Previously Treated Patients Exiting the Wet Age-related Macular Degeneration Extension Study (0910)
Principal investigator William L. Clark, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Palmetto Retina Center, LLC.