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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
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
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 Neovascular Age-Related Macular Degeneration
Actual Study Start Date : March 2016
Primary Completion Date : October 3, 2017
Study Completion Date : October 3, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aflibercept
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. Change from baseline in central subfield retinal thickness (CST) at week 12 through week 36 as measured by spectral domain optical coherence tomography (SD-OCT) [ Time Frame: Baseline to week 36 ]
  2. Change in choroidal neovascularization (CNV) area from baseline [(measured by fluorescein angiography (FA)] at week 12 through week 36 [ Time Frame: Baseline to week 36 ]
  3. Change in total lesion area from baseline (measured by FA) at week 12 through week 36 [ Time Frame: Baseline to week 36 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT02713204


  Show 87 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02713204     History of Changes
Other Study ID Numbers: R910-3-AMD-1517
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017

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