Overview

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Withdrawn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