Treat and Extend Therapy Study Using Intravitreal Aflibercept for Patients Exited From Protocol VGFT-OD 0910 (RANGE)

Palmetto Retina Center, LLC

Status and phase

Unknown

Phase 4

Conditions

Exudative Age-related Macular Degeneration

Treatments

Drug: Aflibercept

Study type

Interventional

Funder types

Other

Identifiers

NCT01961414

VGFT-OD-1319

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.