Open Label Study: Intravitreal Aflibercept Injection for the Treatment of Submacular Vascularized Pigment Epithelial Detachment.

Southern California Desert Retina Consultants, MC3 sites in 1 country40 target enrollmentNovember 2012

ConditionsSubmacular Vascularized Pigment Epithelial Detachments

InterventionsAflibercept

DrugsAflibercept

Overview

Phase: Phase 4
Intervention: Aflibercept
Conditions: Submacular Vascularized Pigment Epithelial Detachments
Sponsor: Southern California Desert Retina Consultants, MC
Enrollment: 40
Locations: 3
Primary Endpoint: Anatomic
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the use of intravitreal aflibercept (anti-VEGF therapy) in patients with a type of macular degeneration known as vascularized pigment epithelial detachment. Previous studies have shown a generally poor outcome in treating this difficult to treat form of wet macular degeneration. More recently, multiple pilot studies have shown positive benefits to using anti-VEGF therapy. This study will evaluate the safety and efficacy of treating vascularize pigment epithelial detachment associated with wet macular degeneration with intravitreal aflibercept injection.

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

September 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Southern California Desert Retina Consultants, MC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is ≥ 50 years of age
•Subject is willing to participate in this study and to follow the criteria and protocol of this study.
•The study eye is treatment naïve regarding treatment of neovascular AMD.
•Subject is not involved with another clinical study currently.
•Subject is willing to follow the protocol outlined in the study.
•Ability to understand the informed consent and willingness to sign the informed consent.
•Presence of a submacular vascularized or fibrovascular PED. The investigator must search for the characteristic features of a vascularized PED summarized here:
•A notch of irregularity associated with an orange-yellow round, oval, or bean-shaped elevation of the RPE with a smooth, convex surface is seen on examination and fundus photography (FP). Fluorescein angiography (FA) shows uniform staining of the PED with a well-defined margin, and more intense staining (hot-spot) for the focus of the CNV.
•A fibrovascular PED with occult neovascularization typically shows stippled hyperfluorescence in the early phase with increasing hyperfluorescent staining and leakage in later phases of FA and a variable surrounding margin. There may be RPE folds.
•Regarding PED with a component of retinal angiomatous proliferation (RAP), the early features on FP including intraretinal neovascularization (IRN) frequently with adjacent small retinal hemorrhages in its lateral expansion in an irregularly stellate pattern before the development of retinal-choroidal anastomosis and the eventual PED in the later phases. The investigator is required to perform indocyanine-green (ICG) angiography at baseline to establish a RAP lesion and to rule-out polypoidal vasculopathy lesions, since the FA images may not be distinct.

Exclusion Criteria

•Any prior treatment of neovascular AMD in eye for proposed enrollment (non-naïve eye), including previous anti-vascular endothelial factor (anti-VEGF) therapy, photodynamic therapy (PDT), radiation therapy, corticosteroid treatment, surgical treatment for CNV, thermal laser treatment, and any other prior treatment for neovascular AMD.
•Known serious allergies to aflibercept, fluorescein dye, drugs for pupillary dilation, topical anesthetic, sterilizing solution (e.g. Betadine Solution).
•Contraindication to pupillary dilation in study eye.
•Any condition (including inability to read visual acuity charts, or language barrier) that may preclude subjects ability to comply with the study protocol and requirements.
•Presence of any advanced systemic condition or end-stage disease, advanced Alzheimer Syndrome, end-stage cancer, etc., which will likely prevent subject from completing study.
•Previous therapeutic radiation in the region of the study eye.
•Prior retinal pigment epithelial (RPE) tear in study eye.
•Prior ocular surgery (except YAG laser capsulotomy) for study within the past 90 days.
•Anticipated ocular surgery (except YAG laser capsulotomy) for the next 12 months
•Prior therapy for AMD (except minerals and vitamins), including laser.

Arms & Interventions

Aflibercept

All subjects will receive aflibercept

Intervention: Aflibercept

Outcomes

Primary Outcomes

Anatomic

Time Frame: 12 months

Detailed anatomic descriptions and grading of lesion components and multi-modal anatomical changes (i.e. FP/FA, ICG, and OCT \[Optical Coherence Tomography\] findings) in a standardized fashion in a reading center setting at baseline and subsequent follow-up visits.

Visual Acuity

Time Frame: 12 months

Mean change in BCVA (Best Corrected Visual Acuity) from baseline measured at 4 meters on an ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 12 months

Secondary Outcomes

Proportion of eyes losing greater than 5 and 15 letters on ETDRS chart(12 months)
Absence or complete resolution of subretinal fluid and cystoid macular edema.(12 monts)
Mean number of injections(12 months)
Status of fluorescein staining or leakage (increased or decreased) from baseline.(12 months)
Proportion of eyes reaching BCVA greater than or equal to 20/200(12 months)
Proportion of eyes gaining greater than or equal to 0, 5, and 15 letters on ETDRS chart.(12 months)
Mean changes in choroidal neovascular lesion (CNV) size on fluorescein angiography (FA) and fundus photography (FP) from baseline.(12 months)
Systemic safety outcome including cardiovascular events, cerebral vascular events(12 months)
Mean reduction in central macular thickness from baseline (central 1mm subfield) as measured on an OCT.(12 Months)
Ocular safety outcome including ocular complications, i.e. RPE tears, uveitis, endophthalmitis(12 months)