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

Withdrawn before enrolling · Phase 4

Conditions studied: Fibrovascular Pigment Epithelial Detachment

In brief

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.

Key facts

Study ID

NCT01495208

Run by

Vitreous -Retina- Macula Consultants of New York

People needed

0

Starts

2011-12-01

Expected to finish

2012-10-01

Last updated by the study team

2018-07-16

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• Vitreous Retina Macula Consultants of New York — New York, New York, United States

Full record on ClinicalTrials.gov

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