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Trial record 3 of 48 for:    regeneron | Open Studies

Study of REGN910 in Patients With Diabetic Macular Edema (DME)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Regeneron Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01997164
First received: November 22, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

This is a double-masked, randomized, multi-center clinical study designed to evaluate the safety and anatomic effects of REGN910 alone and in conjunction with intravitreal (IVT) aflibercept injection in patients with DME.


Condition Intervention Phase
Diabetic Macular Edema
Drug: REGN910
Drug: placebo
Drug: IVT aflibercept injection
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Treatment-emergent adverse events [ Time Frame: baseline to week 6 ] [ Designated as safety issue: Yes ]
    The primary endpoint in this study is the incidence and severity of treatment-emergent adverse events (TEAEs) in patients with DME treated with REGN910 alone and in conjunction with IVT aflibercept injection


Secondary Outcome Measures:
  • Anatomic effects of REGN910 [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]
    The secondary outcomes of this study explore the anatomic effects of REGN910 in the retina


Estimated Enrollment: 60
Study Start Date: December 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Drug: REGN910
Patients randomized to Group 1 will receive REGN910 on day 1/baseline (visit 2) through week 10 (visit 7)
Drug: IVT aflibercept injection

Patients in both groups will receive one IVT aflibercept injection in the study eye

Patients may receive monthly IVT aflibercept injections if certain criteria are met

Experimental: Group 2 Drug: placebo
Patients randomized to Group 2 will receive matching placebo on day 1/baseline (visit 2) through week 10 (visit 7)
Drug: IVT aflibercept injection

Patients in both groups will receive one IVT aflibercept injection in the study eye

Patients may receive monthly IVT aflibercept injections if certain criteria are met


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women ≥18 years of age with type 1 or 2 diabetes mellitus
  2. Patients with clinically significant DME
  3. Willing and able to comply with scheduled clinic visits, treatment plans, laboratory tests, and other study procedures
  4. Able to understand and complete study-related documents
  5. Provide a signed informed consent form (ICF) prior to any study procedures

Exclusion Criteria:

  1. Renal failure, dialysis, or history of renal transplant
  2. Abnormal 12-lead electrocardiogram (ECG) of clinical significance at screening
  3. Uncontrolled hypertension
  4. Anticoagulation/anti-platelet therapy, except aspirin at doses of 325 mg or less per day, low-dose warfarin or low-dose heparin
  5. Major surgery (requiring general anesthesia) within 6 weeks, and other surgery within 4 weeks prior to screening visit
  6. Pregnant or breast-feeding women

(The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a subject's potential participation in this clinical trial).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997164

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United States, Florida
Fort Myers, Florida, United States
Miami, Florida, United States
Winter Haven, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Massachusetts
Boston (2 locations), Massachusetts, United States
Peabody, Massachusetts, United States
United States, New York
New York, New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Ohio
Columbus, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01997164     History of Changes
Other Study ID Numbers: R910-DME-1301
Study First Received: November 22, 2013
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on March 02, 2015