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

Neovascular Age-Related Macular Degeneration Clinical Trial

— ONYX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713204
• Other study ID #: R910-3-AMD-1517
• Status: Completed
• Phase: Phase 2
• Start date: March 31, 2016
• Est. completion date: October 3, 2017

Study information

• Verified date: April 2019
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: October 3, 2017
• Est. primary completion date: October 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-Related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• REGN910-3

• Intravitreal Aflibercept Injection (IAI)

Locations

Country	Name	City	State
United States	Regeneron Investigational Site	'Aiea	Hawaii
United States	Regeneron Investigational Site	Abilene	Texas
United States	Regeneron Investigational Site	Albany	New York
United States	Regeneron Investigational Site	Albuquerque	New Mexico
United States	Regeneron Investigational Site	Altamonte Springs	Florida
United States	Regeneron Investigational Site	Arcadia	California
United States	Regeneron Investigational Site	Asheville	North Carolina
United States	Regeneron Investigational Site	Augusta	Georgia
United States	Regeneron Investigational Site 1	Austin	Texas
United States	Regeneron Investigational Site 2	Austin	Texas
United States	Regeneron Investigational Site	Bakersfield	California
United States	Regeneron Investigational Site 1	Baltimore	Maryland
United States	Regeneron Investigational Site 2	Baltimore	Maryland
United States	Regeneron Investigational Site	Beverly Hills	California
United States	Regeneron Investigational Site	Bloomfield	New York
United States	Regeneron Investigational Site 1	Boston	Massachusetts
United States	Regeneron Investigational Site 2	Boston	Massachusetts
United States	Regeneron Investigational Site	Camp Hill	Pennsylvania
United States	Regeneron Investigational Site	Charlotte	North Carolina
United States	Regeneron Investigational Site	Chevy Chase	Maryland
United States	Regeneron Investigational Site 1	Chicago	Illinois
United States	Regeneron Investigational Site 2	Chicago	Illinois
United States	Regeneron Investigational Site	Cleveland	Ohio
United States	Regeneron Investigational Site	Dallas	Texas
United States	Regeneron Investigational Site	Decatur	Georgia
United States	Regeneron Investigational Site	Des Moines	Iowa
United States	Regeneron Investigational Site	Dublin	Ohio
United States	Regeneron Investigational Site	Durham	North Carolina
United States	Regeneron Investigational Site	Edison	New Jersey
United States	Regeneron Investigational Site	Encino	California
United States	Regeneron Investigational Site	Fort Lauderdale	Florida
United States	Regeneron Investigational Site 1	Fort Worth	Texas
United States	Regeneron Investigational Site 2	Fort Worth	Texas
United States	Regeneron Investigational Site	Germantown	Tennessee
United States	Regeneron Investigational Site	Great Neck	New York
United States	Regeneron Investigational Site	Harlingen	Texas
United States	Regeneron Investigational Site	Hauppauge	New York
United States	Regeneron Investigational Site	Houston	Texas
United States	Regeneron Investigational Site	Huntingdon	Pennsylvania
United States	Regeneron Investigational Site	Jackson	Michigan
United States	Regeneron Investigational Site	Knoxville	Tennessee
United States	Regeneron Investigational Site	Ladson	South Carolina
United States	Regeneron Investigational Site	Lakeland	Florida
United States	Regeneron Investigational Site	Largo	Florida
United States	Regeneron Investigational Site	Las Vegas	Nevada
United States	Regeneron Investigational Site	Lemont	Illinois
United States	Regeneron Investigational Site 1	Los Angeles	California
United States	Regeneron Investigational Site 2	Los Angeles	California
United States	Regeneron Investigational Site	Madison	Wisconsin
United States	Regeneron Investigational Site	Metairie	Louisiana
United States	Regeneron Investigational Site	Miami	Florida
United States	Regeneron Investigational Site	Minneapolis	Minnesota
United States	Regeneron Investigational Site	Mobile	Alabama
United States	Regeneron Investigational Site	Mountain View	California
United States	Regeneron Investigational Site	Naples	Florida
United States	Regeneron Investigational Site	Nashville	Tennessee
United States	Regeneron Investigational Site	New Albany	Indiana
United States	Regeneron Investigational Site	New London	Connecticut
United States	Regeneron Investigational Site	Oak Forest	Illinois
United States	Regeneron Investigational Site	Oak Park	Illinois
United States	Regeneron Investigational Site	Oceanside	California
United States	Regeneron Investigational Site	Palm Beach	Florida
United States	Regeneron Investigational Site 1	Palm Desert	California
United States	Regeneron Investigational Site 2	Palm Desert	California
United States	Regeneron Investigational Site	Palo Alto	California
United States	Regeneron Investigational Site 1	Phoenix	Arizona
United States	Regeneron Investigational Site 2	Phoenix	Arizona
United States	Regeneron Investigational Site 3	Phoenix	Arizona
United States	Regeneron Investigational Site	Portland	Oregon
United States	Regeneron Investigational Site	Portsmouth	New Hampshire
United States	Regeneron Investigational Site	Poway	California
United States	Regeneron Investigational Site	Rapid City	South Dakota
United States	Regeneron Investigational Site	Redlands	California
United States	Regeneron Investigational Site	Rochester	New York
United States	Regeneron Investigational Site	Sacramento	California
United States	Regeneron Investigational Site	Saint Louis	Missouri
United States	Regeneron Investigational Site	Salt Lake City	Utah
United States	Regeneron Investigational Site	Santa Maria	California
United States	Regeneron Investigational Site	Syracuse	New York
United States	Regeneron Investigational Site	Tallahassee	Florida
United States	Regeneron Investigational Site	Teaneck	New Jersey
United States	Regeneron Investigational Site	The Woodlands	Texas
United States	Regeneron Investigational Site 1	Tucson	Arizona
United States	Regeneron Investigational Site 2	Tucson	Arizona
United States	Regeneron Investigational Site	Urbana	Illinois
United States	Regeneron Investigational Site	Willow Park	Texas
United States	Regeneron Investigational Site	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of Participants With No Retinal and/or Subretinal Fluid at Week 12	Retinal and/or subretinal fluid was assessed using intraretinal fluid (IRF) cystoid edema and subretinal fluid (SRF) in the center subfield on optical coherence tomography (OCT). If answers were "no" to both measurements, there was no retinal and/or subretinal fluid (Dry); if "yes" to any of the 2 measurements, there was retinal and/or subretinal fluid (Not Dry); other than the previous 2 cases, retinal and/or subretinal fluid was undetermined.	At Week 12
Other	Proportion of Participants With No Retinal and/or Subretinal Fluid From Baseline Through Week 36	Retinal and/or subretinal fluid was assessed using intraretinal fluid (IRF) cystoid edema and subretinal fluid (SRF) in the center subfield on OCT. If answers were "no" to both measurements, there was no retinal and/or subretinal fluid (Dry); if "yes" to any of the 2 measurements, there was retinal and/or subretinal fluid (Not Dry); other than the previous 2 cases, retinal and/or subretinal fluid was undetermined.	Baseline through Week 36
Other	Time to No Retinal and/or Subretinal Fluid Through Week 36	Kaplan-Meier estimated time to no retinal and/or subretinal fluid through week 36 (days). Retinal and/or subretinal fluid was assessed using intraretinal fluid (IRF) cystoid edema and subretinal fluid (SRF). If answers were "no" to both measurements, there was no retinal and/or subretinal fluid (Dry); if "yes" to any of the 2 measurements, there was retinal and/or subretinal fluid (Not Dry); other than the previous 2 cases, retinal and/or subretinal fluid was undetermined.	Baseline through Week 36
Primary	Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 12	Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Best Corrected Visual Acuity (BCVA) score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 12.	At Week 12
Primary	Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 36	Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 36.	At Week 36
Secondary	Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 12	Central Sub-field Retinal Thickness (CST) was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from last observation carried forward (LOCF) post-baseline value at Week 12.	At Week 12
Secondary	Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 36	CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from LOCF post-baseline value at Week 36.	At Week 36
Secondary	Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 12	Choroidal neovascularization (CNV) was evaluated using fluorescein angiography (FA).CNV area values measured in square millimeters (mm^2); lower values represent better outcomes.	At Week 12
Secondary	Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 36	Choroidal neovascularization (CNV) was evaluated using fluorescein angiography (FA).CNV area values measured in square millimeters (mm^2); lower values represent better outcomes.	At Week 36
Secondary	Change From Baseline in Total Lesion Area at Week 12	Total lesion area was evaluated using fluorescein angiography (FA). Lesion area values measured in square millimeters (mm^2); lower values represent better outcomes.	At Week 12
Secondary	Change From Baseline in Total Lesion Area at Week 36	Total lesion area was evaluated using fluorescein angiography (FA). Lesion area values measured in square millimeters (mm^2); lower values represent better outcomes.	At Week 36