Diabetic Macular EdemaPhase 2RUBYNCT02712008

Anti-vasculaR Endothelial Growth Factor plUs Anti-angiopoietin 2 in Fixed comBination therapY: Evaluation for the Treatment of Diabetic Macular Edema

A Phase 2 study testing REGN910-3 and Intravitreal Aflibercept Injection (IAI) in people with Diabetic Macular Edema, run by Regeneron Pharmaceuticals at 51 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of the study was to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI) in improving best corrected visual acuity (BCVA) in participants with diabetic macular edema (DME). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Macular Edema
What is being tested?: REGN910-3 and Intravitreal Aflibercept Injection (IAI)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 302 participants
Where: 51 sitesUnited States
Study dates: 2 Mar 2016to 10 Jul 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus who have clinically significant DME with central involvement in the study eye
BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the study eye
Willing and able to comply with clinic visits and study-related procedures
Provide signed informed consent

Who cannot join

Evidence of macular edema due to any cause other than diabetes mellitus in either eye
IVT anti-VEGF in the study eye within 12 weeks of the screening visit
Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
Note: Other inclusion/ exclusion criteria apply

Trial locations and contacts

51 sites in 1 country.

City, postcode or hospital

51 sites in 1 country

United States51 sites

Study site
‘Aiea, Hawaii
Study site
Abilene, Texas
Study site
Albany, New York
Study site
Arcadia, California
Study site
Asheville, North Carolina
Study site
Augusta, Georgia
Study site
Austin, Texas
Study site
Baltimore, Maryland
Study site
Bellevue, Washington
Study site
Beverly Hills, California
Study site
Bloomfield, New Jersey
Study site
Boston, Massachusetts
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Colorado Springs, Colorado
Study site
Dallas, Texas
Study site
Decatur, Georgia
Study site
Edison, New Jersey
Study site
Florence, South Carolina
Study site
Florissant, Missouri
Study site
Fort Worth, Texas
Study site
Germantown, Tennessee
Study site
Grand Rapids, Michigan
Study site
Harlingen, Texas
Study site
Houston, Texas
Study site
Jackson, Michigan
Study site
Kingston, Pennsylvania
Study site
Lakeland, Florida
Study site
Las Vegas, Nevada
Study site
Lexington, Kentucky
Study site
Mesa, Arizona
Study site
Minneapolis, Minnesota
Study site
Mountain View, California
Study site
Nashville, Tennessee
Study site
New Albany, Indiana
Study site
New London, Connecticut
Study site
Oceanside, California
Study site
Palm Desert, California
Study site
Portland, Maine
Study site
Rapid City, South Dakota
Study site
Rochester, New York
Study site
Rockville, Maryland
Study site
San Antonio, Texas
Study site
Shawnee Mission, Kansas
Study site
Tampa, Florida
Study site
Teaneck, New Jersey
Study site
The Woodlands, Texas
Study site
Tucson, Arizona
Study site
West Columbia, South Carolina
Study site
Willow Park, Texas
Study site
Winter Haven, Florida

Other trials in United States

About this study

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 Diabetic Macular Edema

Conditions: Diabetic Macular Edema
Being tested: REGN910-3, Intravitreal Aflibercept Injection (IAI)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

REGN910-3Drug
Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)
Intravitreal Aflibercept Injection (IAI)Drug
Also called EYLEA® (aflibercept) Injection, BAY86-5321

Study groups in NCT02712008
Study group	Role	What they receive
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. Receives: Drug: REGN910-3
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 up to week 12. Receives: Drug: REGN910-3
Aflibercept 2 mg	Active comparator	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. Receives: Drug: Intravitreal Aflibercept Injection (IAI)
REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8	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) at Week 16 and Q8 through Week 32. Receives: Drug: REGN910-3
REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12	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) at Week 20 and Q12 through Week 32. Receives: Drug: REGN910-3
Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8	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 at Week16 and Q8 through Week 32. Receives: Drug: Intravitreal Aflibercept Injection (IAI)
Aflibercept 2 mg Q4 to Aflibercept 2 mg Q12	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 at Week 20 and Q12 through Week 32. Receives: Drug: Intravitreal Aflibercept Injection (IAI)
Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8	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 REGN910-3 (6 mg:2 mg) at week 16 and Q8 through week 32. Receives: Drug: REGN910-3; Drug: Intravitreal Aflibercept Injection (IAI)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 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.
Measured: Baseline, Week 36

Secondary outcomes (4)

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 LOCF post-baseline value at Week 12.
Measured: Baseline, 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.
Measured: Baseline, Week 36
Percentage of Participants With a ≥ 2-step Improvement at Week 12 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline
The Diabetic Retinopathy Disease Severity Scale (DRSS) was used to describe overall retinopathy severity. It measured the 5 levels of diabetic retinopathy ranging from absence of retinopathy to severe retinopathy (none, mild, moderate, severe, and proliferative).
Measured: Baseline, Week 12
Percentage of Participants With a ≥ 2-step Improvement at Week 36 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline
The Diabetic Retinopathy Disease Severity Scale (DRSS) was used to describe overall retinopathy severity. It measured the 5 levels of diabetic retinopathy ranging from absence of retinopathy to severe retinopathy (none, mild, moderate, severe, and proliferative).
Measured: Baseline, Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 201610 Jul 2017

First posted17 Mar 2016 (estimated)
Study start2 Mar 2016
Primary completion10 Jul 2017
Study completion10 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 302 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02712008
Sponsor's protocol ID: R910-3-DME-1518
Acronym: RUBY
Status last verified: Oct 2018
First submitted: 14 Mar 2016
Last updated: 3 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

All Diabetic Macular Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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 Diabetic Macular Edema
ClinicalTrials.gov ID: NCT02712008
Acronym / sponsor ID: RUBY / R910-3-DME-1518
Conditions: Diabetic Macular Edema
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 302 participants (actual)
Lead sponsor: Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Bayer
Study start: 2 Mar 2016
Primary completion: 10 Jul 2017 (actual)
Study completion: 10 Jul 2017 (actual)
First posted: 17 Mar 2016 (estimated)
Results: Posted 3 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
REGN910-3 (3 mg: 2 mg)	Experimental	Drug: REGN910-3Participants 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	Drug: REGN910-3Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to week 12.
Aflibercept 2 mg	Active comparator	Drug: Intravitreal Aflibercept Injection (IAI)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.
REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8	Experimental	Drug: REGN910-3Participants 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 and Q8 through Week 32.
REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12	Experimental	Drug: REGN910-3Participants 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 20 and Q12 through Week 32.
Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8	Experimental	Drug: Intravitreal Aflibercept Injection (IAI)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 at Week16 and Q8 through Week 32.
Aflibercept 2 mg Q4 to Aflibercept 2 mg Q12	Experimental	Drug: Intravitreal Aflibercept Injection (IAI)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 at Week 20 and Q12 through Week 32.
Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8	Experimental	Drug: REGN910-3, Drug: Intravitreal Aflibercept Injection (IAI)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) at week 16 and Q8 through week 32.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus who have clinically significant DME with central involvement in the study eye
BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the study eye
Willing and able to comply with clinic visits and study-related procedures
Provide signed informed consent

Key exclusion criteria (4 listed)

Evidence of macular edema due to any cause other than diabetes mellitus in either eye
IVT anti-VEGF in the study eye within 12 weeks of the screening visit
Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
Note: Other inclusion/ exclusion criteria apply

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
REGN910-3Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)	Drug	Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8, REGN910-3 (3 mg: 2 mg), REGN910-3 (6 mg:2 mg), REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12, REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8
Intravitreal Aflibercept Injection (IAI)Also: EYLEA® (aflibercept) Injection, BAY86-5321	Drug	Aflibercept 2 mg, Aflibercept 2 mg Q4 to Aflibercept 2 mg Q12, Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8, Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8

Primary outcome

Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 12
Time frame: Baseline, 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.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 36
Time frame: Baseline, 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.

4 secondary outcomes

Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 36
Time frame: Baseline, Week 36
Percentage of Participants With a ≥ 2-step Improvement at Week 12 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline
Time frame: Baseline, Week 12
Percentage of Participants With a ≥ 2-step Improvement at Week 36 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline
Time frame: Baseline, Week 36

Results and safety

Results posted to the registry on 3 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
REGN910-3 (3 mg: 2 mg)	50	46
REGN910-3 (6 mg:2 mg)	100	97
Aflibercept 2 mg	152	148
REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8	0	0
REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12	0	0
Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8	0	0
Aflibercept 2 mg Q4 to Aflibercept 2 mg Q12	0	0
Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8	0	0

Primary outcome: Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 12

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: Letters correctly read

Measure	REGN910-3 (3 mg: 2 mg) n = 47	REGN910-3 (6 mg:2 mg) n = 99	Aflibercept 2 mg n = 150
Value	6.8 (7.30)	8.5 (6.89)	8.8 (9.71)

REGN910-3 (3 mg: 2 mg) vs Aflibercept 2 mg: Least square mean difference: -2.09 (95% CI - 4.84 to 0.67), p = 0.1368, ANCOVA
REGN910-3 (6 mg:2 mg) vs Aflibercept 2 mg: Least square mean difference: 0.04 (95% CI - 2.10 to 2.18), p = 0.9716, ANCOVA

Population analysed: 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.

Primary outcome: Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 36

Time frame: Baseline, Week 36. Mean (Standard Deviation). Unit: Letters correctly read

Measure	REGN910-3 (3 mg: 2 mg) n = 45	REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8 n = 44	REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12 n = 52	Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8 n = 46	Aflibercept 2 mg Q4 to Aflibercept 2 mg Q12 n = 48	Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 n = 49
Value	9.8 (9.92)	10.3 (8.20)	8.5 (7.74)	8.7 (10.65)	10.0 (10.37)	11.9 (12.01)

REGN910-3 (3 mg: 2 mg) vs Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8: Least square mean difference: 2.15 (95% CI -0.90 to 5.20), p = 0.1665, ANCOVA
REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8 vs Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8: Least square mean difference: 1.90 (95% CI -1.16 to 4.95), p = 0.2223, ANCOVA
REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12 vs Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8: Least square mean difference: 0.39 (95% CI -2.54 to 3.32), p = 0.7943, ANCOVA

Population analysed: FAS secondary randomization set = all participants in full analysis set (FAS) who had completed study through week 12, received any study drug after secondary randomization or after Week 12, had BCVA assessment at Week 12 \& had at least 1 post-Week 16 BCVA assessment. Overall Number of Participants Analyzed=Participants evaluable for this endpoint.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
REGN910-3 (3 mg: 2 mg)	6 of 50 (12%)	18 of 50 (36%)	5 of 50
REGN910-3 (6 mg:2 mg)	18 of 100 (18%)	42 of 100 (42%)	0 of 100
Aflibercept 2 mg	31 of 152 (20.4%)	55 of 152 (36.2%)	4 of 152

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Macular Edema

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
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Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trial Management study director

Regeneron Pharmaceuticals

51 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing REGN910-3 and Intravitreal Aflibercept Injection (IAI) in people with Diabetic Macular Edema, run by Regeneron Pharmaceuticals at 51 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 12 (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02712008.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.