Intense Treatment Regimen With Intravitreal Aflibercept Injection

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and efficacy of intense dosing for a limited period in patients who demonstrate refractory disease on monthly IAI. Patients will be followed for 52 weeks

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vitreous -Retina- Macula Consultants of New York
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

• Age ≥ 50 years

• Choroidal neovascularization related to age-related macular degeneration

• Prior treatment with any anti-VEGF agent for ≥ 12 months

• Prior treatment with at least five consecutive IAI at baseline with an average treatment interval of maximum 35 days

• Presence of foveal fluid at most recent clinical visit occurring 30 (+/- 5) days following the most recent IAI

• Willing and able to comply with clinic visits and study-related procedures

• Provide signed informed consent

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

• Monocular patients

• Patients with a previous history of macular thermal laser or PDT

• Confounding ocular conditions in the study eye that may affect interpretation of OCT, BCVA or assessment of macular appearance (eg. cataract, epiretinal membrane, retinal vascular occlusive disease)

• Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding baseline

• History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye

• Active intraocular inflammation (grade trace or above) in the study eye

• History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye

• Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)

• History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment

• Patients on systemic anti-VEGF treatment

• Pregnant or breastfeeding women

• Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception prior to the initial dose/start of the first treatment, during the study, and for at least 3 months after the last dose. 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; 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 childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.