Trial record 3 of 42 for:    regeneron | Open Studies

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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Regeneron Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02713204
First received: March 14, 2016
Last updated: NA
Last verified: March 2016
History: No changes posted
  Purpose
The primary objective of the study is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

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 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in central subfield retinal thickness (CST) at week 12 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in central subfield retinal thickness (CST) at week 36 [ Time Frame: Baseline to week 36 ] [ Designated as safety issue: No ]
  • Change in choroidal neovascularization (CNV) area from baseline (measured by FA) at week 12 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • Change in CNV area from baseline (measured by FA) at week 36 [ Time Frame: Baseline to week 36 ] [ Designated as safety issue: No ]
  • Change in total lesion area from baseline (measured by FA) at week 12 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • Change in total lesion area from baseline (measured by FA) at week 36 [ Time Frame: Baseline to week 36 ] [ Designated as safety issue: No ]
  • Change from baseline in BCVA measured by the ETDRS letter score at week 36 [ Time Frame: Baseline to week 36 ] [ Designated as safety issue: No ]
  • Proportion of patients with no retinal and/or subretinal fluid at week 12 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • Proportion of patients with no retinal and/or subretinal fluid at week 36 [ Time Frame: Baseline to week 36 ] [ Designated as safety issue: No ]
  • Time to no retinal and/or subretinal fluid at week 12 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • Time to no retinal and/or subretinal fluid at week 36 [ Time Frame: Baseline to week 36 ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: February 2016
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  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: NCT02713204

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United States, California
Regeneron Investigational Site Recruiting
Arcadia, California, United States
United States, Florida
Regeneron Investigational Site Recruiting
Winter Haven, Florida, United States
United States, Indiana
Regeneron Investigational Site Recruiting
New Albany, Indiana, United States
United States, Massachusetts
Regeneron Investigational Site Recruiting
Boston, Massachusetts, United States
United States, South Dakota
Regeneron Investigational Site Recruiting
Rapid City, South Dakota, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02713204     History of Changes
Other Study ID Numbers: R910-3-AMD-1517 
Study First Received: March 14, 2016
Last Updated: March 14, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016