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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)

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ClinicalTrials.gov Identifier: NCT02713204
Recruitment Status : Completed
First Posted : March 18, 2016
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Neovascular Age-Related Macular Degeneration Drug: REGN910-3 Drug: Intravitreal Aflibercept Injection (IAI) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 31, 2016
Actual Primary Completion Date : October 3, 2017
Actual Study Completion Date : October 3, 2017

Resource links provided by the National Library of Medicine


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: REGN910-3
Drug: Intravitreal Aflibercept Injection (IAI)
Other Names:
  • EYLEA® (aflibercept) Injection
  • BAY86-5321




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713204


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Locations
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United States, Alabama
Regeneron Investigational Site
Mobile, Alabama, United States
United States, Arizona
Regeneron Investigational Site 1
Phoenix, Arizona, United States
Regeneron Investigational Site 2
Phoenix, Arizona, United States
Regeneron Investigational Site 3
Phoenix, Arizona, United States
Regeneron Investigational Site 1
Tucson, Arizona, United States
Regeneron Investigational Site 2
Tucson, Arizona, United States
United States, California
Regeneron Investigational Site
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 1
Los Angeles, California, United States
Regeneron Investigational Site 2
Los Angeles, California, United States
Regeneron Investigational Site
Mountain View, California, United States
Regeneron Investigational Site
Oceanside, California, United States
Regeneron Investigational Site 1
Palm Desert, California, United States
Regeneron Investigational Site 2
Palm Desert, California, United States
Regeneron Investigational Site
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
United States, Connecticut
Regeneron Investigational Site
New London, Connecticut, United States
United States, Florida
Regeneron Investigational Site
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
United States, Georgia
Regeneron Investigational Site
Augusta, Georgia, United States
Regeneron Investigational Site
Decatur, Georgia, United States
United States, Hawaii
Regeneron Investigational Site
'Aiea, Hawaii, United States
United States, Illinois
Regeneron Investigational Site 1
Chicago, Illinois, United States
Regeneron Investigational Site 2
Chicago, Illinois, United States
Regeneron Investigational Site
Lemont, Illinois, United States
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Oak Forest, Illinois, United States
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Oak Park, Illinois, United States
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Urbana, Illinois, United States
United States, Indiana
Regeneron Investigational Site
New Albany, Indiana, United States
United States, Iowa
Regeneron Investigational Site
Des Moines, Iowa, United States
United States, Louisiana
Regeneron Investigational Site
Metairie, Louisiana, United States
United States, Maryland
Regeneron Investigational Site 1
Baltimore, Maryland, United States
Regeneron Investigational Site 2
Baltimore, Maryland, United States
Regeneron Investigational Site
Chevy Chase, Maryland, United States
United States, Massachusetts
Regeneron Investigational Site 1
Boston, Massachusetts, United States
Regeneron Investigational Site 2
Boston, Massachusetts, United States
United States, Michigan
Regeneron Investigational Site
Jackson, Michigan, United States
United States, Minnesota
Regeneron Investigational Site
Minneapolis, Minnesota, United States
United States, Missouri
Regeneron Investigational Site
Saint Louis, Missouri, United States
United States, Nevada
Regeneron Investigational Site
Las Vegas, Nevada, United States
United States, New Hampshire
Regeneron Investigational Site
Portsmouth, New Hampshire, United States
United States, New Jersey
Regeneron Investigational Site
Edison, New Jersey, United States
Regeneron Investigational Site
Teaneck, New Jersey, United States
United States, New Mexico
Regeneron Investigational Site
Albuquerque, New Mexico, United States
United States, New York
Regeneron Investigational Site
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
United States, North Carolina
Regeneron Investigational Site
Asheville, North Carolina, United States
Regeneron Investigational Site
Charlotte, North Carolina, United States
Regeneron Investigational Site
Durham, North Carolina, United States
United States, Ohio
Regeneron Investigational Site
Cleveland, Ohio, United States
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Dublin, Ohio, United States
United States, Oregon
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Portland, Oregon, United States
United States, Pennsylvania
Regeneron Investigational Site
Camp Hill, Pennsylvania, United States
Regeneron Investigational Site
Huntingdon, Pennsylvania, United States
United States, South Carolina
Regeneron Investigational Site
Ladson, South Carolina, United States
United States, South Dakota
Regeneron Investigational Site
Rapid City, South Dakota, United States
United States, Tennessee
Regeneron Investigational Site
Germantown, Tennessee, United States
Regeneron Investigational Site
Knoxville, Tennessee, United States
Regeneron Investigational Site
Nashville, Tennessee, United States
United States, Texas
Regeneron Investigational Site
Abilene, Texas, United States
Regeneron Investigational Site 1
Austin, Texas, United States
Regeneron Investigational Site 2
Austin, Texas, United States
Regeneron Investigational Site
Dallas, Texas, United States
Regeneron Investigational Site 1
Fort Worth, Texas, United States
Regeneron Investigational Site 2
Fort Worth, Texas, United States
Regeneron Investigational Site
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
United States, Utah
Regeneron Investigational Site
Salt Lake City, Utah, United States
United States, Wisconsin
Regeneron Investigational Site
Madison, Wisconsin, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Regeneron Pharmaceuticals:
Study Protocol  [PDF] May 31, 2017
Statistical Analysis Plan  [PDF] October 19, 2017


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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02713204     History of Changes
Other Study ID Numbers: R910-3-AMD-1517
First Posted: March 18, 2016    Key Record Dates
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases