Open Label to Study to Evaluate Effect of Alfilbercept on Patients With (FVPED) Fibrovascular Pigment Epithelial Detachment

• Status: Withdrawn
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label study to evaluate the efficacy of intravitreal aflibercept injection 2mg in patients with a persistent FVPED despite at least 6 consecutive injections with ranibizumab 0.5 mg.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

• Ability to provide written informed consent and comply with study assessments for the full duration of the study

• Age > 50 years

• Subfoveal FVPED assessed using clinical examination and OCT

• Best corrected visual acuity in the study eye between 20 and 85 letters on the ETDRS chart (20/30 to 20/800 Snellen equivalent)

• Prior treatment with at least 6 consecutive injections with ranibizumab 0.5 mg prior to the baseline visit; the last treatment with ranibizumab should not exceed 45 days from the baseline visit.

Exclusion Criteria:

• Pregnancy (positive pregnancy test) or lactation

• Participation in another simultaneous medical investigation or trial

• Prior treatment with ranibizumab therapy in the study eye within 30 days of baseline

• Prior treatment with PDT in the study eye

• Prior intravitreal injection of a corticosteroid (triamcinolone, dexamethasone) within 120 days from baseline.

• Presence of significant subfoveal fibrosis or atrophy determined using SDOCT, fluorescein angiography and clinical examination.

• Presence of fibrous or fibrocellular material occupying more than 50% of the sub-RPE space; assessed using EDI OCT

• Presence of a RPE tear, determined by clinical examination, FA, FAF and OCT

• Intraocular surgery (including cataract surgery) in the study eye within 90 days preceding baseline

• History of pars plana vitrectomy, submacular surgery or any other surgical intervention for vitreo-retinal diseases in the study eye

• Presence of or previous history of diabetic macular edema or proliferative diabetic retinopathy.

• History of uveitis in the study eye

• Current vitreous hemorrhage in the study eye

• History of rhegmatogenous retinal detachment, macular hole and lamellar hole and in the study eye

• Ocular or periocular infection

• Active severe intraocular inflammation

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

• In patients with glaucoma, advanced field loss; mean deviation on threshold visual field of more than 12 decibels.

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

• History of allergy to fluorescein, ICG or iodine, not amenable to treatment

• Known hypersensitivity to aflibercept or to any of the excipients