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

Vitreous -Retina- Macula Consultants of New York

Status and phase

Withdrawn

Phase 4

Conditions

Fibrovascular Pigment Epithelial Detachment

Treatments

Drug: Aflibercept

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01495208

EVER STUDY

Details and patient eligibility

About

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.

Full 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.

Patients being evaluated at VRM New York with neovascular AMD who have persistent sub-foveal FVPED on OCT despite at least 6 consecutive ranibizumab injections will be considered for the study.

We aim to recruit 25 patients in the study. There have been no statistical tests to calculate sample size; sample size of 25 patients is chosen, making sure that it is feasible financially to conduct the study and logistically to complete the study within 24 weeks. This is a pilot study to assess the effects of intravitreal aflibercept injection on chronic, persistent FVPEDs; currently there is no data regarding visual and anatomical outcomes for this group of patients.

Patients will be reviewed at baseline and then at 4 week intervals (28 ± 7 days). They will receive intravitreal intravitreal aflibercept injection 2mg at each visit. The primary end point of the study is 24 weeks from baseline. Patients who complete the study will have received 6 injections of intravitreal aflibercept injection 2mg.

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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