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Trial record 3 of 3 for:    REGN910-3

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02712008
First Posted: March 17, 2016
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
  Purpose
The primary objective of the study is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI) in improving best corrected visual acuity (BCVA) in patients with diabetic macular edema (DME).

Condition Intervention Phase
Diabetic Macular Edema Drug: REGN910-3 Drug: Intravitreal Aflibercept Injection (IAI) Phase 2

Study Type: Interventional
Study Design: 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 Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in BCVA measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at week 12 through week 36 [ Time Frame: Baseline to week 36 ]

Secondary Outcome Measures:
  • Change from baseline in central subfield retinal thickness (CST) at week 12 through week 36 [ Time Frame: Baseline to week 36 ]
  • Proportion of patients with a ≥2-step improvement in Diabetic Retinopathy Severity Scale from baseline at week 12 through week 36 [ Time Frame: Baseline to week 36 ]

Other Outcome Measures:
  • Proportion of patients with no retinal and/or subretinal fluid at week 12 through week 36 [ Time Frame: Baseline to week 36 ]
  • Time to no retinal and/or subretinal fluid through week 36 [ Time Frame: Baseline to week 36 ]

Enrollment: 304
Actual Study Start Date: March 2016
Study Completion Date: July 10, 2017
Primary Completion Date: July 10, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Participants in Group 1 will receive REGN910-3 dosing regimen 1
Drug: REGN910-3
Experimental: Group 2
Participants in Group 2 will receive REGN910-3 dosing regimen 2
Drug: REGN910-3
Active Comparator: Group 3
Participants in Group 3 will receive IAI
Drug: Intravitreal Aflibercept Injection (IAI)
Other Names:
  • EYLEA® (aflibercept) Injection
  • BAY86-5321

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT02712008


  Show 51 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02712008     History of Changes
Other Study ID Numbers: R910-3-DME-1518
First Submitted: March 14, 2016
First Posted: March 17, 2016
Last Update Posted: October 20, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs