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

NCT02713204 | Completed Phase 2 Results

• 1 other identifier: R910-3-AMD-1517
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 87

Brief Summary

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

Conditions

Neovascular Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• 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

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

  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

  At Week 36

• Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 12

  At Week 12

• Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 36

  At Week 36

• Change From Baseline in Total Lesion Area at Week 12

  At Week 12

Other Outcomes (3)

• Proportion of Participants With No Retinal and/or Subretinal Fluid at Week 12

  At Week 12

• Proportion of Participants With No Retinal and/or Subretinal Fluid From Baseline Through Week 36

  Baseline through Week 36

• Time to No Retinal and/or Subretinal Fluid Through Week 36

  Baseline through Week 36

Study Arms (3)

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.

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.

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.

Drug: REGN910-3; Drug: Intravitreal Aflibercept Injection (IAI)

Interventions

REGN910-3 DRUG

Aflibercept (IAI) 2 mg; REGN910-3 (3 mg: 2 mg); REGN910-3 (6 mg:2 mg)

Intravitreal Aflibercept Injection (IAI) DRUG

Also known as: EYLEA® (aflibercept) Injection, BAY86-5321

Aflibercept (IAI) 2 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (87)

Regeneron Investigational Site

Mobile, Alabama, United States

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Regeneron Investigational Site 1

Phoenix, Arizona, United States

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Regeneron Investigational Site 2

Phoenix, Arizona, United States

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Regeneron Investigational Site 3

Phoenix, Arizona, United States

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Regeneron Investigational Site 1

Tucson, Arizona, United States

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Regeneron Investigational Site 2

Tucson, Arizona, United States

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Arcadia, California, United States

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Bakersfield, California, United States

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Beverly Hills, California, United States

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Encino, California, United States

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Regeneron Investigational Site 1

Los Angeles, California, United States

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Regeneron Investigational Site 2

Los Angeles, California, United States

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Mountain View, California, United States

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Oceanside, California, United States

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Regeneron Investigational Site 1

Palm Desert, California, United States

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Regeneron Investigational Site 2

Palm Desert, California, United States

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Palo Alto, California, United States

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Poway, California, United States

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Redlands, California, United States

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Sacramento, California, United States

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Santa Maria, California, United States

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New London, Connecticut, United States

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Altamonte Springs, Florida, United States

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Fort Lauderdale, Florida, United States

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Lakeland, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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Palm Beach, Florida, United States

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Tallahassee, Florida, United States

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Winter Haven, Florida, United States

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Augusta, Georgia, United States

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Decatur, Georgia, United States

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‘Aiea, Hawaii, United States

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Regeneron Investigational Site 1

Chicago, Illinois, United States

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Regeneron Investigational Site 2

Chicago, Illinois, United States

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Lemont, Illinois, United States

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Oak Forest, Illinois, United States

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Oak Park, Illinois, United States

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Urbana, Illinois, United States

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New Albany, Indiana, United States

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Des Moines, Iowa, United States

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Metairie, Louisiana, United States

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Regeneron Investigational Site 1

Baltimore, Maryland, United States

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Regeneron Investigational Site 2

Baltimore, Maryland, United States

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Chevy Chase, Maryland, United States

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Regeneron Investigational Site 1

Boston, Massachusetts, United States

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Regeneron Investigational Site 2

Boston, Massachusetts, United States

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Jackson, Michigan, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Portsmouth, New Hampshire, United States

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Edison, New Jersey, United States

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Teaneck, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Bloomfield, New York, United States

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Great Neck, New York, United States

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Hauppauge, New York, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Cleveland, Ohio, United States

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Dublin, Ohio, United States

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Portland, Oregon, United States

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Camp Hill, Pennsylvania, United States

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Huntingdon, Pennsylvania, United States

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Ladson, South Carolina, United States

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Rapid City, South Dakota, United States

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Germantown, Tennessee, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Abilene, Texas, United States

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Regeneron Investigational Site 1

Austin, Texas, United States

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Regeneron Investigational Site 2

Austin, Texas, United States

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Regeneron Investigational Site

Dallas, Texas, United States

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Regeneron Investigational Site 1

Fort Worth, Texas, United States

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Regeneron Investigational Site 2

Fort Worth, Texas, United States

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Regeneron Investigational Site

Harlingen, Texas, United States

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Houston, Texas, United States

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The Woodlands, Texas, United States

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Willow Park, Texas, United States

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Salt Lake City, Utah, United States

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Regeneron Investigational Site

Madison, Wisconsin, United States

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MeSH Terms

Interventions

aflibercept; Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Clinical Trial Management
• Organization: Regeneron Pharmaceuticals

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 18, 2016
• Study Start: March 31, 2016
• Primary Completion: October 3, 2017
• Study Completion: October 3, 2017
• Last Updated: May 7, 2019
• Results First Posted: May 7, 2019

Record last verified: 2019-04

Locations

US (87)