Anti-angiOpoeitin 2 Plus Anti-vascular eNdothelial Growth Factor as a therapY for Neovascular Age Related Macular Degeneration: Evaluation of a fiXed Combination Intravitreal Injection (ONYX)

May 1, 2019 updated by: Regeneron Pharmaceuticals

A Randomized, Double-Masked, Active-Controlled Phase 2 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal REGN910-3 in Patients With Neovascular Age-Related Macular Degeneration

The primary objective of the study is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

365

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States
        • Regeneron Investigational Site
    • Arizona
      • Phoenix, Arizona, United States
        • Regeneron Investigational Site 1
      • Phoenix, Arizona, United States
        • Regeneron Investigational Site 2
      • Phoenix, Arizona, United States
        • Regeneron Investigational Site 3
      • Tucson, Arizona, United States
        • Regeneron Investigational Site 1
      • Tucson, Arizona, United States
        • Regeneron Investigational Site 2
    • California
      • Arcadia, California, United States
        • Regeneron Investigational Site
      • Bakersfield, California, United States
        • Regeneron Investigational Site
      • Beverly Hills, California, United States
        • Regeneron Investigational Site
      • Encino, California, United States
        • Regeneron Investigational Site
      • Los Angeles, California, United States
        • Regeneron Investigational Site 1
      • Los Angeles, California, United States
        • Regeneron Investigational Site 2
      • Mountain View, California, United States
        • Regeneron Investigational Site
      • Oceanside, California, United States
        • Regeneron Investigational Site
      • Palm Desert, California, United States
        • Regeneron Investigational Site 1
      • Palm Desert, California, United States
        • Regeneron Investigational Site 2
      • Palo Alto, California, United States
        • Regeneron Investigational Site
      • Poway, California, United States
        • Regeneron Investigational Site
      • Redlands, California, United States
        • Regeneron Investigational Site
      • Sacramento, California, United States
        • Regeneron Investigational Site
      • Santa Maria, California, United States
        • Regeneron Investigational Site
    • Connecticut
      • New London, Connecticut, United States
        • Regeneron Investigational Site
    • Florida
      • Altamonte Springs, Florida, United States
        • Regeneron Investigational Site
      • Fort Lauderdale, Florida, United States
        • Regeneron Investigational Site
      • Lakeland, Florida, United States
        • Regeneron Investigational Site
      • Largo, Florida, United States
        • Regeneron Investigational Site
      • Miami, Florida, United States
        • Regeneron Investigational Site
      • Naples, Florida, United States
        • Regeneron Investigational Site
      • Palm Beach, Florida, United States
        • Regeneron Investigational Site
      • Tallahassee, Florida, United States
        • Regeneron Investigational Site
      • Winter Haven, Florida, United States
        • Regeneron Investigational Site
    • Georgia
      • Augusta, Georgia, United States
        • Regeneron Investigational Site
      • Decatur, Georgia, United States
        • Regeneron Investigational Site
    • Hawaii
      • 'Aiea, Hawaii, United States
        • Regeneron Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • Regeneron Investigational Site 1
      • Chicago, Illinois, United States
        • Regeneron Investigational Site 2
      • Lemont, Illinois, United States
        • Regeneron Investigational Site
      • Oak Forest, Illinois, United States
        • Regeneron Investigational Site
      • Oak Park, Illinois, United States
        • Regeneron Investigational Site
      • Urbana, Illinois, United States
        • Regeneron Investigational Site
    • Indiana
      • New Albany, Indiana, United States
        • Regeneron Investigational Site
    • Iowa
      • Des Moines, Iowa, United States
        • Regeneron Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States
        • Regeneron Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • Regeneron Investigational Site 1
      • Baltimore, Maryland, United States
        • Regeneron Investigational Site 2
      • Chevy Chase, Maryland, United States
        • Regeneron Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Regeneron Investigational Site 1
      • Boston, Massachusetts, United States
        • Regeneron Investigational Site 2
    • Michigan
      • Jackson, Michigan, United States
        • Regeneron Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Regeneron Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States
        • Regeneron Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Regeneron Investigational Site
    • New Hampshire
      • Portsmouth, New Hampshire, United States
        • Regeneron Investigational Site
    • New Jersey
      • Edison, New Jersey, United States
        • Regeneron Investigational Site
      • Teaneck, New Jersey, United States
        • Regeneron Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Regeneron Investigational Site
    • New York
      • Albany, New York, United States
        • Regeneron Investigational Site
      • Bloomfield, New York, United States
        • Regeneron Investigational Site
      • Great Neck, New York, United States
        • Regeneron Investigational Site
      • Hauppauge, New York, United States
        • Regeneron Investigational Site
      • Rochester, New York, United States
        • Regeneron Investigational Site
      • Syracuse, New York, United States
        • Regeneron Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States
        • Regeneron Investigational Site
      • Charlotte, North Carolina, United States
        • Regeneron Investigational Site
      • Durham, North Carolina, United States
        • Regeneron Investigational Site
    • Ohio
      • Cleveland, Ohio, United States
        • Regeneron Investigational Site
      • Dublin, Ohio, United States
        • Regeneron Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • Regeneron Investigational Site
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States
        • Regeneron Investigational Site
      • Huntingdon, Pennsylvania, United States
        • Regeneron Investigational Site
    • South Carolina
      • Ladson, South Carolina, United States
        • Regeneron Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States
        • Regeneron Investigational Site
    • Tennessee
      • Germantown, Tennessee, United States
        • Regeneron Investigational Site
      • Knoxville, Tennessee, United States
        • Regeneron Investigational Site
      • Nashville, Tennessee, United States
        • Regeneron Investigational Site
    • Texas
      • Abilene, Texas, United States
        • Regeneron Investigational Site
      • Austin, Texas, United States
        • Regeneron Investigational Site 1
      • Austin, Texas, United States
        • Regeneron Investigational Site 2
      • Dallas, Texas, United States
        • Regeneron Investigational Site
      • Fort Worth, Texas, United States
        • Regeneron Investigational Site 1
      • Fort Worth, Texas, United States
        • Regeneron Investigational Site 2
      • Harlingen, Texas, United States
        • Regeneron Investigational Site
      • Houston, Texas, United States
        • Regeneron Investigational Site
      • The Woodlands, Texas, United States
        • Regeneron Investigational Site
      • Willow Park, Texas, United States
        • Regeneron Investigational Site
    • Utah
      • Salt Lake City, Utah, United States
        • Regeneron Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States
        • Regeneron Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  1. Men or women ≥50 years of age with active subfoveal CNV secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye as assessed by a central reading center
  2. BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the study eye.
  3. Willing and able to comply with clinic visits and study-related procedures.
  4. Provide signed informed consent.

Key Exclusion Criteria:

  1. Evidence of CNV due to any cause other than AMD in either eye
  2. Prior IVT anti-VEGF in the study eye
  3. Evidence of DME or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients
  4. Any history of macular hole of stage 2 and above in the study eye

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REGN910-3 (3 mg: 2 mg)
Participants were administered intravitreal injection of REGN910-3 (3 milligram [mg]:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 up to Week 32.
Drug: REGN910-3
Experimental: REGN910-3 (6 mg:2 mg)
Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.
Drug: REGN910-3
Experimental: Aflibercept (IAI) 2 mg
Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.
Drug: Intravitreal Aflibercept Injection (IAI)
Other Names:
  • BAY86-5321
  • EYLEA® (aflibercept) Injection
Drug: REGN910-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 12
Time Frame: At Week 12
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Best Corrected Visual Acuity (BCVA) score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 12.
At Week 12
Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 36
Time Frame: At Week 36
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 36.
At Week 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 12
Time Frame: At Week 12
Central Sub-field Retinal Thickness (CST) was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from last observation carried forward (LOCF) post-baseline value at Week 12.
At Week 12
Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 36
Time Frame: At Week 36
CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from LOCF post-baseline value at Week 36.
At Week 36
Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 12
Time Frame: At Week 12
Choroidal neovascularization (CNV) was evaluated using fluorescein angiography (FA).CNV area values measured in square millimeters (mm^2); lower values represent better outcomes.
At Week 12
Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 36
Time Frame: At Week 36
Choroidal neovascularization (CNV) was evaluated using fluorescein angiography (FA).CNV area values measured in square millimeters (mm^2); lower values represent better outcomes.
At Week 36
Change From Baseline in Total Lesion Area at Week 12
Time Frame: At Week 12
Total lesion area was evaluated using fluorescein angiography (FA). Lesion area values measured in square millimeters (mm^2); lower values represent better outcomes.
At Week 12
Change From Baseline in Total Lesion Area at Week 36
Time Frame: At Week 36
Total lesion area was evaluated using fluorescein angiography (FA). Lesion area values measured in square millimeters (mm^2); lower values represent better outcomes.
At Week 36

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With No Retinal and/or Subretinal Fluid at Week 12
Time Frame: At Week 12
Retinal and/or subretinal fluid was assessed using intraretinal fluid (IRF) cystoid edema and subretinal fluid (SRF) in the center subfield on optical coherence tomography (OCT). If answers were "no" to both measurements, there was no retinal and/or subretinal fluid (Dry); if "yes" to any of the 2 measurements, there was retinal and/or subretinal fluid (Not Dry); other than the previous 2 cases, retinal and/or subretinal fluid was undetermined.
At Week 12
Proportion of Participants With No Retinal and/or Subretinal Fluid From Baseline Through Week 36
Time Frame: Baseline through Week 36
Retinal and/or subretinal fluid was assessed using intraretinal fluid (IRF) cystoid edema and subretinal fluid (SRF) in the center subfield on OCT. If answers were "no" to both measurements, there was no retinal and/or subretinal fluid (Dry); if "yes" to any of the 2 measurements, there was retinal and/or subretinal fluid (Not Dry); other than the previous 2 cases, retinal and/or subretinal fluid was undetermined.
Baseline through Week 36
Time to No Retinal and/or Subretinal Fluid Through Week 36
Time Frame: Baseline through Week 36
Kaplan-Meier estimated time to no retinal and/or subretinal fluid through week 36 (days). Retinal and/or subretinal fluid was assessed using intraretinal fluid (IRF) cystoid edema and subretinal fluid (SRF). If answers were "no" to both measurements, there was no retinal and/or subretinal fluid (Dry); if "yes" to any of the 2 measurements, there was retinal and/or subretinal fluid (Not Dry); other than the previous 2 cases, retinal and/or subretinal fluid was undetermined.
Baseline through Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2016

Primary Completion (Actual)

October 3, 2017

Study Completion (Actual)

October 3, 2017

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

March 14, 2016

First Posted (Estimate)

March 18, 2016

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 1, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R910-3-AMD-1517

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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