Anti-vasculaR Endothelial Growth Factor plUs Anti-angiopoietin 2 in Fixed comBination therapY: Evaluation for the Treatment of Diabetic Macular Edema (RUBY)

October 1, 2018 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 Diabetic Macular Edema

The primary objective of the study was to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI) in improving best corrected visual acuity (BCVA) in participants with diabetic macular edema (DME).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

302

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
    • Arizona
      • Mesa, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Arcadia, California, United States
      • Beverly Hills, California, United States
      • Mountain View, California, United States
      • Oceanside, California, United States
      • Palm Desert, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
    • Connecticut
      • New London, Connecticut, United States
    • Florida
      • Lakeland, Florida, United States
      • Tampa, Florida, United States
      • Winter Haven, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
      • Decatur, Georgia, United States
    • Hawaii
      • 'Aiea, Hawaii, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • New Albany, Indiana, United States
    • Kansas
      • Shawnee Mission, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Maine
      • Portland, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Rockville, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Grand Rapids, Michigan, United States
      • Jackson, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • Florissant, Missouri, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Bloomfield, New Jersey, United States
      • Edison, New Jersey, United States
      • Teaneck, New Jersey, United States
    • New York
      • Albany, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Charlotte, North Carolina, United States
    • Pennsylvania
      • Kingston, Pennsylvania, United States
    • South Carolina
      • Florence, South Carolina, United States
      • West Columbia, South Carolina, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Abilene, Texas, United States
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • Fort Worth, Texas, United States
      • Harlingen, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
      • The Woodlands, Texas, United States
      • Willow Park, Texas, United States
    • Washington
      • Bellevue, Washington, United States

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  1. Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus who have clinically significant DME with central involvement in the study eye
  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 macular edema due to any cause other than diabetes mellitus in either eye
  2. IVT anti-VEGF in the study eye within 12 weeks of the screening visit
  3. Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening

Note: Other inclusion/ exclusion criteria apply

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
Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)
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 up to week 12.
Drug: REGN910-3
Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)
Active Comparator: Aflibercept 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.
Drug: Intravitreal Aflibercept Injection (IAI)
Other Names:
  • BAY86-5321
  • EYLEA® (aflibercept) Injection
Experimental: REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8
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) at Week 16 and Q8 through Week 32.
Drug: REGN910-3
Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)
Experimental: REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12
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) at Week 20 and Q12 through Week 32.
Drug: REGN910-3
Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)
Experimental: Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8
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 at Week16 and Q8 through Week 32.
Drug: Intravitreal Aflibercept Injection (IAI)
Other Names:
  • BAY86-5321
  • EYLEA® (aflibercept) Injection
Experimental: Aflibercept 2 mg Q4 to Aflibercept 2 mg Q12
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 at Week 20 and Q12 through Week 32.
Drug: Intravitreal Aflibercept Injection (IAI)
Other Names:
  • BAY86-5321
  • EYLEA® (aflibercept) Injection
Experimental: Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8
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 REGN910-3 (6 mg:2 mg) at week 16 and Q8 through week 32.
Drug: REGN910-3
Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)
Drug: Intravitreal Aflibercept Injection (IAI)
Other Names:
  • BAY86-5321
  • EYLEA® (aflibercept) Injection

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: Baseline, 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.
Baseline, 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: Baseline, 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.
Baseline, 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: Baseline, 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 LOCF post-baseline value at Week 12.
Baseline, 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: Baseline, 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.
Baseline, Week 36
Percentage of Participants With a ≥ 2-step Improvement at Week 12 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline
Time Frame: Baseline, Week 12
The Diabetic Retinopathy Disease Severity Scale (DRSS) was used to describe overall retinopathy severity. It measured the 5 levels of diabetic retinopathy ranging from absence of retinopathy to severe retinopathy (none, mild, moderate, severe, and proliferative).
Baseline, Week 12
Percentage of Participants With a ≥ 2-step Improvement at Week 36 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline
Time Frame: Baseline, Week 36
The Diabetic Retinopathy Disease Severity Scale (DRSS) was used to describe overall retinopathy severity. It measured the 5 levels of diabetic retinopathy ranging from absence of retinopathy to severe retinopathy (none, mild, moderate, severe, and proliferative).
Baseline, Week 36

Collaborators and Investigators

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

Sponsor

Regeneron Pharmaceuticals

Collaborators

Bayer

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

March 2, 2016

Primary Completion (Actual)

July 10, 2017

Study Completion (Actual)

July 10, 2017

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

March 14, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Actual)

October 3, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R910-3-DME-1518

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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