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The primary objective of the study is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN910-3 (3 mg: 2 mg) | Experimental | Participants were administered intravitreal injection of REGN910-3 (3 milligram [mg]:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 up to Week 32. |
|
| REGN910-3 (6 mg:2 mg) | Experimental | Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32. |
|
| Aflibercept (IAI) 2 mg | Experimental | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN910-3 | Drug |
| ||
| Intravitreal Aflibercept Injection (IAI) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Investigational Site | Mobile | Alabama | United States | |||
| Regeneron Investigational Site 1 |
Out of 560 participants, 365 were randomized & treated. Participants were randomized in 1:2:3 to receive REGN910-3 3:2mg, REGN910-3 6:2mg & 2mg intravitreal aflibercept injection (IAI) followed by re-randomization at week 12 in REGN910-3 6:2mg & IAI 2mg arm. Not all participants who completed Week 12 were re-randomized & continued to Week 36.
The study was conducted at 87 sites in the United States. A total of 560 participants were screened in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | REGN910-3 (3 mg:2 mg) | Participants were administered intravitreal injection of REGN910-3 (3 milligram [mg]:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32. |
| FG001 | REGN910-3 (6 mg:2 mg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline (Day 1) up to Week 12 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 31, 2017 | Oct 3, 2018 |
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| Drug |
|
|
| At Week 12 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| At Week 12 |
| 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 |
| 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 |
| Phoenix |
| Arizona |
| United States |
| Regeneron Investigational Site 2 | Phoenix | Arizona | United States |
| Regeneron Investigational Site 3 | Phoenix | Arizona | United States |
| Regeneron Investigational Site 1 | Tucson | Arizona | United States |
| Regeneron Investigational Site 2 | Tucson | Arizona | United States |
| Regeneron Investigational Site | Arcadia | California | United States |
| Regeneron Investigational Site | Bakersfield | California | United States |
| Regeneron Investigational Site | Beverly Hills | California | United States |
| Regeneron Investigational Site | Encino | California | United States |
| Regeneron Investigational Site 1 | Los Angeles | California | United States |
| Regeneron Investigational Site 2 | Los Angeles | California | United States |
| Regeneron Investigational Site | Mountain View | California | United States |
| Regeneron Investigational Site | Oceanside | California | 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 | Poway | California | United States |
| Regeneron Investigational Site | Redlands | California | United States |
| Regeneron Investigational Site | Sacramento | California | United States |
| Regeneron Investigational Site | Santa Maria | California | United States |
| Regeneron Investigational Site | New London | Connecticut | United States |
| Regeneron Investigational Site | Altamonte Springs | Florida | United States |
| Regeneron Investigational Site | Fort Lauderdale | Florida | United States |
| Regeneron Investigational Site | Lakeland | Florida | United States |
| Regeneron Investigational Site | Largo | Florida | United States |
| Regeneron Investigational Site | Miami | Florida | United States |
| Regeneron Investigational Site | Naples | Florida | United States |
| Regeneron Investigational Site | Palm Beach | Florida | United States |
| Regeneron Investigational Site | Tallahassee | Florida | United States |
| Regeneron Investigational Site | Winter Haven | Florida | United States |
| Regeneron Investigational Site | Augusta | Georgia | United States |
| Regeneron Investigational Site | Decatur | Georgia | United States |
| Regeneron Investigational Site | ‘Aiea | Hawaii | United States |
| Regeneron Investigational Site 1 | Chicago | Illinois | United States |
| Regeneron Investigational Site 2 | Chicago | Illinois | United States |
| Regeneron Investigational Site | Lemont | Illinois | United States |
| Regeneron Investigational Site | Oak Forest | Illinois | United States |
| Regeneron Investigational Site | Oak Park | Illinois | United States |
| Regeneron Investigational Site | Urbana | Illinois | United States |
| Regeneron Investigational Site | New Albany | Indiana | United States |
| Regeneron Investigational Site | Des Moines | Iowa | United States |
| Regeneron Investigational Site | Metairie | Louisiana | United States |
| Regeneron Investigational Site 1 | Baltimore | Maryland | United States |
| Regeneron Investigational Site 2 | Baltimore | Maryland | United States |
| Regeneron Investigational Site | Chevy Chase | Maryland | United States |
| Regeneron Investigational Site 1 | Boston | Massachusetts | United States |
| Regeneron Investigational Site 2 | Boston | Massachusetts | United States |
| Regeneron Investigational Site | Jackson | Michigan | United States |
| Regeneron Investigational Site | Minneapolis | Minnesota | United States |
| Regeneron Investigational Site | St Louis | Missouri | United States |
| Regeneron Investigational Site | Las Vegas | Nevada | United States |
| Regeneron Investigational Site | Portsmouth | New Hampshire | United States |
| Regeneron Investigational Site | Edison | New Jersey | United States |
| Regeneron Investigational Site | Teaneck | New Jersey | United States |
| Regeneron Investigational Site | Albuquerque | New Mexico | United States |
| Regeneron Investigational Site | Albany | New York | United States |
| Regeneron Investigational Site | Bloomfield | New York | United States |
| Regeneron Investigational Site | Great Neck | New York | United States |
| Regeneron Investigational Site | Hauppauge | New York | United States |
| Regeneron Investigational Site | Rochester | New York | United States |
| Regeneron Investigational Site | Syracuse | New York | United States |
| Regeneron Investigational Site | Asheville | North Carolina | United States |
| Regeneron Investigational Site | Charlotte | North Carolina | United States |
| Regeneron Investigational Site | Durham | North Carolina | United States |
| Regeneron Investigational Site | Cleveland | Ohio | United States |
| Regeneron Investigational Site | Dublin | Ohio | United States |
| Regeneron Investigational Site | Portland | Oregon | United States |
| Regeneron Investigational Site | Camp Hill | Pennsylvania | United States |
| Regeneron Investigational Site | Huntingdon | Pennsylvania | United States |
| Regeneron Investigational Site | Ladson | South Carolina | United States |
| Regeneron Investigational Site | Rapid City | South Dakota | United States |
| Regeneron Investigational Site | Germantown | Tennessee | United States |
| Regeneron Investigational Site | Knoxville | Tennessee | United States |
| Regeneron Investigational Site | Nashville | Tennessee | United States |
| Regeneron Investigational Site | Abilene | Texas | United States |
| Regeneron Investigational Site 1 | Austin | Texas | United States |
| Regeneron Investigational Site 2 | Austin | Texas | United States |
| Regeneron Investigational Site | Dallas | Texas | United States |
| Regeneron Investigational Site 1 | Fort Worth | Texas | United States |
| Regeneron Investigational Site 2 | Fort Worth | Texas | United States |
| Regeneron Investigational Site | Harlingen | Texas | United States |
| Regeneron Investigational Site | Houston | Texas | United States |
| Regeneron Investigational Site | The Woodlands | Texas | United States |
| Regeneron Investigational Site | Willow Park | Texas | United States |
| Regeneron Investigational Site | Salt Lake City | Utah | United States |
| Regeneron Investigational Site | Madison | Wisconsin | United States |
Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32. |
| FG002 | Aflibercept 2 mg | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. |
| FG003 | REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8 | Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. |
| FG004 | REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12 | Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q12 beginning at Week 20 through Week 32. |
| FG005 | Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At week 12, participants were re-randomized to receive IAI Q8 beginning at week 16 through week 32. |
| FG006 | Aflibercept 2 mg Q4 to Aflibercept 2 mg Q12 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32. |
| FG007 | Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. |
| COMPLETED |
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| NOT COMPLETED |
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| From Week 12 up to Week 36 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | REGN910-3 (3 mg:2 mg) | Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32. |
| BG001 | REGN910-3 (6 mg:2 mg) | Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at Week 16 or Week 20 and Q8 or Q12 through Week 32. |
| BG002 | Aflibercept (IAI) 2 mg | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here "Overall Number of Participants Analyzed" = Participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Letters correctly read | At Week 12 |
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| 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. | Posted | Mean | Standard Deviation | Letters correctly read | At Week 36 |
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| 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. | Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here "Overall Number of Participants Analyzed" = Participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Microns | At Week 12 |
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| 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. | FAS secondary randomization set was used. Here "Overall Number of Participants Analyzed"= Participants who were evaluable for this endpoint. | Posted | Mean | Standard Deviation | Microns | At Week 36 |
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| 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. | Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here "Overall Number of Participants Analyzed" = Participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mm^2 | At Week 12 |
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| 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. | Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here "Overall Number of Participants Analyzed" = Participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mm^2 | At Week 36 |
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| 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. | Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here "Overall Number of Participants Analyzed" = Participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mm^2 | At Week 12 |
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| 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. | Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here "Overall Number of Participants Analyzed" = Participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mm^2 | At Week 36 |
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| Other Pre-specified | 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. | Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here "Overall Number of Participants Analyzed" = Participants who were evaluable for this outcome measure. | Posted | Number | Proportion of participants | At Week 12 |
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| Other Pre-specified | 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. | Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here "Overall Number of Participants Analyzed" = Participants who were evaluable for this outcome measure. | Posted | Number | Proportion of participants | Baseline through Week 36 |
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| Other Pre-specified | 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. | Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here "Overall Number of Participants Analyzed" = Participants who were evaluable for this outcome measure. | Posted | Mean | Standard Error | Days | Baseline through Week 36 |
|
Timeframe for AE reporting
Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | REGN910-3 3 mg:2 mg | Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32. | 1 | 60 | 11 | 60 | 17 | 60 |
| EG001 | REGN910-3 6 mg:2 mg | Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32. | 2 | 122 | 20 | 122 | 41 | 122 |
| EG002 | IAI 2 mg | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. | 7 | 183 | 30 | 183 | 51 | 183 |
| EG003 | IAI 2mg to REGN910-3 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. Data in this arm include only the 58 participants that switched to high dose at week 16. Data from these 58 participants are also included in the Aflibercept (IAI) 2 mg arm (n = 183). | 3 | 58 | 8 | 58 | 20 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cardio-Respiratory arrest | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Corneal oedema | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dry age-related macular degeneration | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Iritis | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Retinal degeneration | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Intestinal mass | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Diverticulitis intestinal haemorrhagic | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Medical device site joint infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Eschar | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Lung adenocarcinoma stage iv | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Carotid arteriosclerosis | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Genital prolapse | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Neovascular age-related macular degeneration | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | 844-734-6643 | clinicaltrials@regeneron.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 19, 2017 | Oct 3, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| C533178 | aflibercept |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Death |
|
| Lost to Follow-up |
|
| Participant Re-located |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors. |
| ANCOVA |
| 0.8346 |
| Least square mean difference |
| 0.25 |
| 2-Sided |
| 95 |
| -2.09 |
| 2.59 |
| Superiority |
| OG002 |
| REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12 |
Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q12 beginning at Week 20 through Week 32. |
| OG003 | Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32. |
| OG004 | Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32. |
| OG005 | Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. |
|
|
|
| OG002 | Aflibercept (IAI) 2 mg | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. |
|
|
|
| REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12 |
Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q12 beginning at Week 20 through Week 32. |
| OG003 | Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q8 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32. |
| OG004 | Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32. |
| OG005 | Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. |
|
|
|
Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. |
|
|
|
Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q12 beginning at Week 20 through Week 32. |
| OG003 | Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q8 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32 |
| OG004 | Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32. |
| OG005 | Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. |
|
|
|
Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.
|
|
|
Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q12 beginning at Week 20 through Week 32. |
| OG003 | Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q8 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32. |
| OG004 | Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32. |
| OG005 | Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. |
|
|
|
| OG002 | Aflibercept (IAI) 2 mg | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. |
|
|
| OG002 | REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12 | Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q12 beginning at Week 20 through Week 32. |
| OG003 | Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q8 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32. |
| OG004 | Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32. |
| OG005 | Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. |
|
|
| OG002 | REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12 | Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q12 beginning at Week 20 through Week 32. |
| OG003 | Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q8 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32. |
| OG004 | Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32. |
| OG005 | Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. |
|
|