Status:
WITHDRAWN
Open Label to Study to Evaluate Effect of Alfilbercept on Patients With (FVPED) Fibrovascular Pigment Epithelial Detachment
Lead Sponsor:
Vitreous -Retina- Macula Consultants of New York
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Fibrovascular Pigment Epithelial Detachment
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief 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.
Detailed Description
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. P...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01495208
Start Date
December 1 2011
End Date
October 1 2012
Last Update
July 16 2018
Active Locations (1)
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1
Vitreous Retina Macula Consultants of New York
New York, New York, United States, 10022