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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

Tracking Information
First Submitted Date  ICMJE March 14, 2016
First Posted Date  ICMJE March 18, 2016
Results First Submitted Date  ICMJE October 3, 2018
Results First Posted Date  ICMJE May 7, 2019
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE March 31, 2016
Actual Primary Completion Date October 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
Change from baseline in BCVA measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at week 12 [ Time Frame: Baseline to week 12 ]
Change History Complete list of historical versions of study NCT02713204 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
  • Change from baseline in central subfield retinal thickness (CST) at week 12 [ Time Frame: Baseline to week 12 ]
  • Change from baseline in central subfield retinal thickness (CST) at week 36 [ Time Frame: Baseline to week 36 ]
  • Change in choroidal neovascularization (CNV) area from baseline (measured by FA) at week 12 [ Time Frame: Baseline to week 12 ]
  • Change in CNV area from baseline (measured by FA) at week 36 [ Time Frame: Baseline to week 36 ]
  • Change in total lesion area from baseline (measured by FA) at week 12 [ Time Frame: Baseline to week 12 ]
  • Change in total lesion area from baseline (measured by FA) at week 36 [ Time Frame: Baseline to week 36 ]
  • Change from baseline in BCVA measured by the ETDRS letter score at week 36 [ Time Frame: Baseline to week 36 ]
  • Proportion of patients with no retinal and/or subretinal fluid at week 12 [ Time Frame: Baseline to week 12 ]
  • Proportion of patients with no retinal and/or subretinal fluid at week 36 [ Time Frame: Baseline to week 36 ]
  • Time to no retinal and/or subretinal fluid at week 12 [ Time Frame: Baseline to week 12 ]
  • Time to no retinal and/or subretinal fluid at week 36 [ Time Frame: Baseline to week 36 ]
Current Other Pre-specified Outcome Measures
 (submitted: May 1, 2019)
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neovascular Age-Related Macular Degeneration
Intervention  ICMJE
  • Drug: REGN910-3
  • Drug: Intravitreal Aflibercept Injection (IAI)
    Other Names:
    • EYLEA® (aflibercept) Injection
    • BAY86-5321
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
    Interventions:
    • Drug: REGN910-3
    • Drug: Intravitreal Aflibercept Injection (IAI)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2017)
365
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2016)
360
Actual Study Completion Date  ICMJE October 3, 2017
Actual Primary Completion Date October 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02713204
Other Study ID Numbers  ICMJE R910-3-AMD-1517
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP