Study of Intravitreal REGN2176-3 in Participants With Neovascular ("Wet") Age-Related Macular Degeneration (AMD)

NCT02418754 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: R2176-3-AMD-1417
• Study Type: interventional
• Target: 505
• Locations: 2 countries
• Sites: 84

Brief Summary

The primary objective of the study was to explore the effect of REGN2176-3 on the Early Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (AMD), compared to intravitreal aflibercept injection (IAI) monotherapy. The secondary objectives of the study were the following:

• To explore the effect of 2 dose levels of IVT REGN2176-3 on anatomical changes of CNV in participants with nAMD compared to IAI monotherapy (at week 12)
• To evaluate if short-term treatment with REGN2176-3 followed by IAI monotherapy offered the same or additional benefit compared to continuous treatment with REGN2176-3. Also to determine if there was benefit in initiating IAI treatment prior to REGN2176-3 compared to continuous treatment with IAI.
• To assess the safety and tolerability of IVT REGN2176-3 in participants with nAMD

Conditions

Neovascular Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye at Week 12

  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 12.

  Baseline, Week 12

Secondary Outcomes (7)

• Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 12, as Measured by Optical Coherence Tomography (OCT)

  Baseline, Week 12

• Percentage of Participants With Complete Resolution of Intraretinal and Subretinal Fluid From Baseline at Week 12 Measured by Optical Coherence Tomography (OCT)

  Week 12

• Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 12 Measured by Fluorescein Angiography (FA)

  Baseline, Week 12

• Change From Baseline in Total Lesion Size at Week 12 Measured by Fluorescein Angiography (FA)

  Baseline, Week 12

• Percentage of Participants Who Gained At Least 15 Letters in BCVA From Baseline at Week 12, Measured by 4-meter Early Treatment Diabetic Retinopathy Scale (ETDRS)

  Week 12

Study Arms (5)

REGN2176-3 (1 mg: 2 mg)

EXPERIMENTAL

Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. After Week 12, dosing was monthly up to Week 28, then criteria based re-dosing from Week 28-52.

Drug: REGN2176-3

REGN2176-3 (3 mg: 2 mg)

EXPERIMENTAL

Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. After Week 12, dosing was monthly up to Week 28, then criteria based re-dosing from Week 28-52.

Drug: REGN2176-3

Intravitreal Aflibercept Injection (IAI) 2 mg

EXPERIMENTAL

IAI every 4 weeks for 12 weeks. After Week 12, dosing was monthly up to Week 28, then criteria based re-dosing from Week 28-52.

Drug: Intravitreal Aflibercept Injection (IAI)

REGN2176-3 (3 mg: 2 mg) to IAI 2 mg

EXPERIMENTAL

Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. After Week 12, dosing was monthly with IAI 2 mg up to Week 28, then criteria based re-dosing from Week 28-52.

Drug: Intravitreal Aflibercept Injection (IAI)

IAI 2 mg to REGN2176-3 (3 mg:2 mg)

EXPERIMENTAL

IAI every 4 weeks for 12 weeks. After Week 12, dosing was monthly with REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) up to Week 28, then criteria based re-dosing from Week 28-52.

Drug: REGN2176-3

Interventions

REGN2176-3 DRUG

IAI 2 mg to REGN2176-3 (3 mg:2 mg); REGN2176-3 (1 mg: 2 mg); REGN2176-3 (3 mg: 2 mg)

Intravitreal Aflibercept Injection (IAI) DRUG

Also known as: Eylea®

Intravitreal Aflibercept Injection (IAI) 2 mg; REGN2176-3 (3 mg: 2 mg) to 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
• Active subfoveal CNV secondary to AMD as evidenced by FA in the study eye, as determined by the reading center, including juxtafoveal lesions that affect the fovea
• BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye at the screening visit
• Provide signed informed consent

You may not qualify if:

• Any prior treatment with anti-VEGF treatment in the study eye
• Any prior treatment (ie, systemic or ocular treatment) with PDGF or PDGFR inhibitors
• Dense fibrotic scar or atrophy in the study eye involving the center of the fovea
• Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
• Prior vitrectomy in the study eye
• Any history of macular hole of stage 2 and above in the study eye
• Any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery
• History of corneal transplant in the study eye
• Evidence of diabetic retinopathy or diabetic macular edema in either eye
• Positive serum human chorionic gonadotropin/urine pregnancy test at the screening or baseline visit

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (84)

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Arcadia, California, United States

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Beverly Hills, California, United States

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Irvine, California, United States

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Mountain View, California, United States

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Oceanside, California, United States

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Sacramento, California, United States

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Santa Ana, California, United States

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Colorado Springs, Colorado, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Plantation, Florida, United States

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Tampa, Florida, United States

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Winter Haven, Florida, United States

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Augusta, Georgia, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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Oak Forest, Illinois, United States

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Springfield, Illinois, United States

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Urbana, Illinois, United States

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Iowa City, Iowa, United States

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Shawnee Mission, Kansas, United States

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Lexington, Kentucky, United States

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Paducah, Kentucky, United States

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Baltimore, Maryland, United States

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Towson, Maryland, United States

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Boston, Massachusetts, United States

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Jackson, Michigan, United States

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Southfield, Michigan, United States

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Minneapolis, Minnesota, United States

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Florissant, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Bloomfield, New Jersey, United States

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New Brunswick, 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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East Setauket, New York, United States

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Great Neck, New York, United States

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New York, New York, United States

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Orchard Park, New York, United States

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Rochester, 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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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Kingston, Pennsylvania, United States

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Monroeville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Florence, South Carolina, United States

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Ladson, South Carolina, United States

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West Columbia, South Carolina, United States

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Rapid City, South Dakota, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Abilene, Texas, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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McAllen, Texas, United States

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San Antonio, 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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Burlington, Vermont, United States

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Fairfax, Virginia, United States

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Bellevue, Washington, United States

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Akita, Japan

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Asahikawa, Japan

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Chiyoda-ku, Japan

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Fukushima, Japan

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Kawasaki, Japan

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Matsumoto, Japan

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Nagasaki, Japan

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Nagoya, Japan

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Osaka, Japan

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MeSH Terms

Interventions

aflibercept

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 16, 2015
• Study Start: May 5, 2015
• Primary Completion: August 17, 2016
• Study Completion: April 3, 2017
• Last Updated: October 26, 2020
• Results First Posted: October 26, 2020

Record last verified: 2020-10

Locations

JP (9); US (75)