Neovascular Age-Related Macular DegenerationPhase 2ONYXNCT02713204

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

A Phase 2 study testing REGN910-3 and Intravitreal Aflibercept Injection (IAI) in people with Neovascular Age-Related Macular Degeneration, run by Regeneron Pharmaceuticals at 87 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 is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI). Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Neovascular Age-Related Macular Degeneration
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: 365 participants
Where: 87 sitesUnited States
Study dates: 31 Mar 2016to 3 Oct 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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
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 CNV due to any cause other than AMD in either eye
Prior IVT anti-VEGF in the study eye
Evidence of DME or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients
Any history of macular hole of stage 2 and above in the study eye

Trial locations and contacts

87 sites in 1 country.

City, postcode or hospital

87 sites in 1 country

United States87 sites

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

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

Conditions: Neovascular Age-Related Macular Degeneration
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
Intravitreal Aflibercept Injection (IAI)Drug
Also called EYLEA® (aflibercept) Injection, BAY86-5321

Study groups in NCT02713204
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. 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. Receives: Drug: REGN910-3
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. 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: 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.
Measured: At Week 36

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Week 36

Timeline

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

31 Mar 20163 Oct 2017

First posted18 Mar 2016 (estimated)
Study start31 Mar 2016
Primary completion3 Oct 2017
Study completion3 Oct 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 Neovascular Age-Related Macular DegenerationStudies 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: 365 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02713204
Sponsor's protocol ID: R910-3-AMD-1517
Acronym: ONYX
Status last verified: Apr 2019
First submitted: 14 Mar 2016
Last updated: 7 May 2019
Results posted: Yes, on ClinicalTrials.gov

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

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A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
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All Neovascular Age-Related Macular Degeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2019. 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 Neovascular Age-Related Macular Degeneration
ClinicalTrials.gov ID: NCT02713204
Acronym / sponsor ID: ONYX / R910-3-AMD-1517
Conditions: Neovascular Age-Related Macular Degeneration
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 365 participants (actual)
Lead sponsor: Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 31 Mar 2016 (actual)
Primary completion: 3 Oct 2017 (actual)
Study completion: 3 Oct 2017 (actual)
First posted: 18 Mar 2016 (estimated)
Results: Posted 7 May 2019

Clinical summary

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

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

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. 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	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 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.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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
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 CNV due to any cause other than AMD in either eye
Prior IVT anti-VEGF in the study eye
Evidence of DME or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients
Any history of macular hole of stage 2 and above in the study eye

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
REGN910-3	Drug	Aflibercept (IAI) 2 mg, REGN910-3 (3 mg: 2 mg), REGN910-3 (6 mg:2 mg)
Intravitreal Aflibercept Injection (IAI)Also: EYLEA® (aflibercept) Injection, BAY86-5321	Drug	Aflibercept (IAI) 2 mg

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

6 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: 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
Time frame: At Week 36
Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 12
Time frame: At Week 12
Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 36
Time frame: At Week 36
Change From Baseline in Total Lesion Area at Week 12
Time frame: At Week 12
Change From Baseline in Total Lesion Area at Week 36
Time frame: At Week 36

Results and safety

Results posted to the registry on 7 May 2019, 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)	60	59
REGN910-3 (6 mg:2 mg)	122	121
Aflibercept 2 mg	183	181
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: At Week 12. Mean (Standard Deviation). Unit: Letters correctly read

Measure	REGN910-3 (3 mg:2 mg) n = 59	REGN910-3 (6 mg:2 mg) n = 122	Aflibercept (IAI) 2 mg n = 183
Value	5.2 (10.51)	5.6 (10.59)	5.4 (9.85)

REGN910-3 (3 mg:2 mg) vs Aflibercept (IAI) 2 mg: Least square mean difference: 0.02 (95% CI -2.99 to 3.03), p = 0.9894, ANCOVA
REGN910-3 (6 mg:2 mg) vs Aflibercept (IAI) 2 mg: Least square mean difference: 0.25 (95% CI -2.09 to 2.59), p = 0.8346, 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: At Week 36. Mean (Standard Deviation). Unit: Letters correctly read

Measure	REGN910-3 (3 mg:2 mg) n = 58	REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8 n = 57	REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12 n = 62	Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8 n = 60	Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 n = 62	Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 n = 58
Value	5.9 (11.95)	6.0 (12.00)	6.4 (12.24)	6.9 (12.49)	4.2 (12.50)	2.9 (12.16)

REGN910-3 (3 mg:2 mg) vs Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8: Least square mean difference: -1.20 (95% CI -4.41 to 2.00), p = 0.4611, ANCOVA
REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8 vs Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8: Least square mean difference: -2.00 (95% CI -5.22 to 1.22), p = 0.2225, ANCOVA
REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12 vs Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8: Least square mean difference: -0.82 (95% CI -3.97 to 2.32), p = 0.6063, ANCOVA

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Timeframe for AE reporting. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
REGN910-3 3 mg:2 mg	11 of 60 (18.3%)	17 of 60 (28.3%)	1 of 60
REGN910-3 6 mg:2 mg	20 of 122 (16.4%)	41 of 122 (33.6%)	2 of 122
IAI 2 mg	30 of 183 (16.4%)	51 of 183 (27.9%)	7 of 183
IAI 2mg to REGN910-3	8 of 58 (13.8%)	20 of 58 (34.5%)	3 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Neovascular Age-Related Macular Degeneration

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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

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

Questions about this trial

What is this clinical trial studying?

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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 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 7 May 2019). 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: At 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 NCT02713204.

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 7 May 2019.