Submacular Vascularized Pigment Epithelial DetachmentsPhase 4EVENNCT01722656

Intravitreal Aflibercept Injection for the Treatment of Submacular Vascularized Pigment Epithelial Detachment

A Phase 4 study testing Aflibercept in people with Submacular Vascularized Pigment Epithelial Detachments, run by Southern California Desert Retina Consultants, MC at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Submacular Vascularized Pigment Epithelial Detachments
What is being tested?: Aflibercept
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 3 sitesUnited States
Study dates: Nov 2012to Sep 2015
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.
The investigator must also search for other features associated with a PED indicating the presence of a vascular component, i.e. hemorrhage, exudates, and/or chorioretinal folds.
The investigator must confirm the presence of a PED on FA/FP and OCT. Spectral Domain OCT will be utilized. Specifically, the Spectralis OCT manufactured by Heidleberg to maintain uniformity for all the sites. The PED height, SA, GLD, and volume will be measured from the OCT images. The characteristic OCT findings of the vascularized PED must be confirmed, including a distinct elevation of the highly hyperreflective RPE layer with mild backscattering of the underlying choroidal layer in the portion of the PED without any CNV. For the portion of the PED with underlying CNV, typical OCT findings consist of moderate hyperreflectivity contiguous to the overlying markedly hyperreflective detached RPE corresponding to the CNV that usually extends to the choroidal layer. Besides the OCT characteristics confirmation must be made on the FP/FA images of the vascularized PED, as outlined above in detail.
Central foveal involvement by the PED or the CNV due to age-related macular degeneration (AMD). The CNV may be classic, occult, or mixed, as long as it is associated with a PED. The CNV may be within the PED or adjacent to the margin of the PED.
PED ≤ 12 disc area in size.
BCVA with ETDRS of ≥ 19 letters and ≤ 73 letters (20/400 to 20/40).
Evidence of submacular fluid outside or surrounding the PED.
Surface area of the submacular hemorrhage needs to be < 50% of the entire PED.
Submacular fibrosis needs to be < 50% of the entire PED.
Sufficiently clear media (cornea, anterior chamber, lens, vitreous) for OCT, FA and FP.
Intraocular pressure (IOP) of 25mmHg or less in the study eye, with or without use of ocular hypotensive agents.
Prior treatment of neovascular AMD or any other forms of neovascularization in the fellow eye, including anti-VEGF or other forms of therapy targeted specifically for the fellow eye does not exclude the fellow eye from enrollment in this study. Prior focal corticosteroid treatment is allowed, as long as there is a lack of involvement of the study eye. However prior (within 90 days of Day 0) or current systemic corticosteroid therapy (oral or intravenous corticosteroid treatment) is not permitted.

Who cannot join

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.

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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.
Prior vitrectomy
Presence of any causes of CNV and PED other than due to AMD.
Presence of any substantial ocular disease (other than the CNV and PED) that may compromise vision in the study eye and/or confound interpretation of the data; e.g. substantial cataracts, concomitant diabetic retinopathy affecting the macula, advanced glaucoma, optic neuritis, optic neuropathy, or atrophy, marked macular atrophy, ocular vascular occlusion, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
Presence of ocular disease other than AMD affecting study eye, i.e. presumed ocular histoplasmosis syndrome, android streaks, pathologic myopia (spherical equivalent of ≥ -8 diopters of myopia or axial length of ≥ 25mm), choroidal rupture, multifocal choroiditis, etc.
Active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at screening
Serous PED without neovascularization and polypoidal choroidal vasculopathy (PCV) lesions are excluded.
Prior or current systemic anti-VEGF
Prior (within 90 days of Day 0) or current corticosteroid therapy (oral or intravenous corticosteroid treatments).
Sexually active men* or women of child-bearing potential who are unwilling to practice adequate contraception during the study (adequate contraception measures include, stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly) *Contraception is not required for men with documented vasectomy. Post-menopausal women must be amenorrheic for at least 12 months in order not to be considered of child-bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Jules Stein Eye Institute
Los Angeles, California, 90095
Southern California Desert Retina Consultants
Palm Desert, California, 92211
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701

Other trials in United States

About this study

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

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.

Conditions: Submacular Vascularized Pigment Epithelial Detachments
Being tested: Aflibercept
Keywords: PED, AMD, CNV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AfliberceptDrug

Study groups in NCT01722656
Study group	Role	What they receive
Aflibercept	Other	All subjects will receive aflibercept Receives: Drug: Aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Acuity
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
Measured: 12 months
Anatomic
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.
Measured: 12 months

Secondary outcomes (10)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Sep 2015

First posted7 Nov 2012 (estimated)
Study startNov 2012
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Submacular Vascularized Pigment Epithelial DetachmentsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01722656
Sponsor's protocol ID: EVEN Study
Acronym: EVEN
Status last verified: Jan 2016
First submitted: 2 Nov 2012
Last updated: 22 Jan 2016
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label Study: Intravitreal Aflibercept Injection for the Treatment of Submacular Vascularized Pigment Epithelial Detachment.
ClinicalTrials.gov ID: NCT01722656
Acronym / sponsor ID: EVEN / EVEN Study
Conditions: Submacular Vascularized Pigment Epithelial Detachments
Keywords: PED, AMD, CNV
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Southern California Desert Retina Consultants, MCUniversity, hospital or other
Collaborators: Regeneron Pharmaceuticals
Study start: Nov 2012
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 7 Nov 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Aflibercept	Other	Drug: AfliberceptAll subjects will receive aflibercept

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aflibercept	Drug	Aflibercept

Primary outcome

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
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.

10 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clement K Chan, M.D. principal investigator

Southern California Desert Retina Consultants

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aflibercept in people with Submacular Vascularized Pigment Epithelial Detachments, run by Southern California Desert Retina Consultants, MC at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Acuity (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01722656.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2016.