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)

Study Description

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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 Design

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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
Actual Primary Completion Date :	October 3, 2017
Actual Study Completion Date :	October 3, 2017

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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 ]

Eligibility Criteria

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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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 87 Study Locations

Sponsors and Collaborators

Regeneron Pharmaceuticals

Investigators

Study Director:	Clinical Trial Management	Regeneron Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT02713204 History of Changes
Other Study ID Numbers:	R910-3-AMD-1517
First Posted:	March 18, 2016
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