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Age - Related Macular Degeneration (AMD)Phase 4RE-VIEWNCT01722045

Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection)

A Phase 4 study testing Intravitreal Aflibercept Injection (IAI) in people with Age - Related Macular Degeneration (AMD), run by Regeneron Pharmaceuticals at 49 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

This is a phase 4, open-label, single arm, multicenter, clinical study in patients with neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept Injection (IAI) administered over 2 years , and to provide clinical information from the first year in the trial evaluating the adverse… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age - Related Macular Degeneration (AMD)
What is being tested?
Intravitreal Aflibercept Injection (IAI)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
49 sitesUnited States
Study dates
Nov 2012to Sep 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Men or women great than or equal to 50 years of age with unilateral neovascular AMD
  • BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
  • Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye
  • The CNV area must be at least 50% of total lesion size
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent
  • Provide signed Health Insurance Portability and Accountability Act (HIPAA) authorization

Who cannot join

  • Neovascular AMD in the fellow eye
  • Corneal endothelial measures as judged by an independent reading center
  • Any prior use of intraocular anti-VEGF treatment for neovascular AMD in either eye
  • Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema
  • History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening
  • History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening, or yttrium aluminum garnet (YAG) Capsulotomy within 3 months of screening
Show all 23Show fewer
  • Contact lens wear in either eye within 6 months of screening
  • History of angle closure glaucoma in either eye
  • Intraocular laser therapy including selective laser trabeculoplasty (SLT), YAG, prophylactic peripheral iridotomy (PI) in either eye within 1 year of screening, or YAG Capsulotomy within 3 months of screening
  • History of cataract surgery requiring an anterior chamber intraocular lens implant at any time in either eye
  • Any prior ocular trauma (blunt or penetrating) in either eye
  • Embedded corneal foreign body in either eye
  • Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
  • Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
  • Any prior ocular inflammation/infection in either eye within 3 months of the screening visit
  • Any prior use of amantadine
  • Significant pre-retinal fibrosis involving the macula in the study eye (where, in the opinion of the investigator, the pre-retinal fibrosis is causing distortion or traction on the central macular region which may be limiting vision, or inducing retinal edema/thickening, beyond that due to underlying CNV)
  • Intraocular pressure (IOP) greater than or equal to 30 mm Hg in the study eye at screening
  • Uncontrolled diabetes mellitus (DM) (HbA1c ≥8)
  • Current treatment with systemic anti-VEGF therapeutics at screening
  • Known serious allergy to the fluorescein sodium for injection in angiography
  • Participation in an investigational study within 30 days prior to the screening visit that involved treatment with any drug (excluding vitamins and minerals) or device.
  • Positive serum hCG pregnancy test at the screening visit

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

United States49 sites

  • Study site

    Arlington, Texas

  • Study site

    Asheville, North Carolina

  • Study site

    Augusta, Georgia

  • Study site

    Beverly Hills, California

  • Study site

    Bloomfield, New Jersey

  • Study site

    Boston, Massachusetts

  • Study site

    Boynton Beach, Florida

  • Study site

    Colorado Springs, Colorado

  • Study site

    Florence, South Carolina

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Golden, Colorado

  • Study site

    Houston, Texas

  • Study site

    Jackson, Michigan

  • Study site

    Kingston, Pennsylvania

  • Study site

    Ladson, South Carolina

  • Study site

    Las Vegas, Nevada

  • Study site

    Lawrenceville, New Jersey

  • Study site

    Lexington, Kentucky

  • Study site

    Lincoln, Nebraska

  • Study site

    Nashville, Tennessee

  • Study site

    New Albany, Indiana

  • Study site

    Northfield, New Jersey

  • Study site

    Oak Park, Illinois

  • Study site

    Oakland, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Palm Desert, California

  • Study site

    Pensacola, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plantation, Florida

  • Study site

    Portland, Oregon

  • Study site

    Portsmouth, New Hampshire

  • Study site

    Rapid City, South Dakota

  • Study site

    Rochester, New York

  • Study site

    Sacramento, California

  • Study site

    Salem, Oregon

  • Study site

    San Antonio, Texas

  • Study site

    Santa Ana, California

  • Study site

    Seattle, Washington

  • Study site

    Tampa, Florida

  • Study site

    Teaneck, New Jersey

  • Study site

    Tucson, Arizona

  • Study site

    West Columbia, South Carolina

  • Study site

    Westlake Village, California

  • Study site

    Wichita, Kansas

  • Study site

    Winter Haven, Florida

  • Study site

    Worcester, Massachusetts

Other trials in United States

About this study

Official title: An Open-Label Study of the Efficacy, Safety, and Tolerability of Intravitreal Administration of VEGF Trap-Eye (Intravitreal Aflibercept Injection) in Patients With Neovascular Age-Related Macular Degeneration

This is a phase 4, open-label, single arm, multicenter, clinical study in patients with neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept Injection (IAI) administered over 2 years , and to provide clinical information from the first year in the trial evaluating the adverse effects, if any, on the corneal endothelium following administration of IAI.

Being tested
Intravitreal Aflibercept Injection (IAI)
Keywords
AMD
Medical subject headings
Macular Degeneration

What participants receive

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

  • Intravitreal Aflibercept Injection (IAI)Drug

Study groups in NCT01722045
Study groupRoleWhat they receive
Open label IAIExperimentalNot described
Receives: Drug: Intravitreal Aflibercept Injection (IAI)

What is being measured

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

  1. Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score From Baseline to Week 100 - Last Observation Carried Forward (LOCF)

    Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed.

    Measured: Baseline to Week 100

Secondary outcomes (5)

  1. Percentage of Participants Whose Optical Coherence Tomography (OCT) Status Was "Dry" at Week 52 and at Week 100 (LOCF)

    Retinal fluid status was evaluated using spectral domain OCT on the study eye at every study visit. Last observation carried forward (LOCF) method was used to impute missing data.

    Measured: Baseline to Week 100

  2. Percentage of Participants Who Gained ≥15 ETDRS Letters Compared With Baseline at Week 52 and Week 100 (LOCF)

    Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed.

    Measured: At week 52 and At week 100

  3. Change From Baseline in Best Corrected Visual Acuity Score Through Week 52 (LOCF)

    Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision.

    Measured: Baseline to Week 52

  4. Percentage of Participants Who Gained ≥0, ≥5, ≥10, or ≥30 Letters From Baseline in BCVA Through Week 100 (LOCF)

    Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.

    Measured: Baseline to Week 100

  5. Percentage of Patients Who Lost >0, ≥5, ≥10, or ≥15 Letters From Baseline in BCVA Through Week 100 (LOCF)

    Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.

    Measured: Baseline to Week 100

Timeline

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

  1. First posted6 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

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
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01722045
Sponsor's protocol ID
VGFTe-AMD-1124
Acronym
RE-VIEW
Status last verified
Nov 2017
First submitted
2 Nov 2012
Last updated
22 Dec 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intravitreal Aflibercept Injection (IAI) in people with Age - Related Macular Degeneration (AMD), run by Regeneron Pharmaceuticals at 49 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 7 inclusion and 23 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 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 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?

Yes. Results are posted in the registry (first posted 22 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score From Baseline to Week 100 - Last Observation Carried Forward (LOCF) (time frame: Baseline to Week 100). 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 NCT01722045.

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 Dec 2017.

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