Study of Intravitreal REGN2176-3 in Participants With Neovascular ("Wet") Age-Related Macular Degeneration (AMD)
NCT ID: NCT02418754
Last Updated: 2020-10-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
505 participants
INTERVENTIONAL
2015-05-05
2017-04-03
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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REGN2176-3 (1 mg: 2 mg)
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.
REGN2176-3
REGN2176-3 (3 mg: 2 mg)
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.
REGN2176-3
Intravitreal Aflibercept Injection (IAI) 2 mg
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.
Intravitreal Aflibercept Injection (IAI)
REGN2176-3 (3 mg: 2 mg) to IAI 2 mg
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.
Intravitreal Aflibercept Injection (IAI)
IAI 2 mg to REGN2176-3 (3 mg:2 mg)
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.
REGN2176-3
Interventions
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REGN2176-3
Intravitreal Aflibercept Injection (IAI)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
3. BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye at the screening visit
4. Provide signed informed consent
Exclusion Criteria
2. Any prior treatment (ie, systemic or ocular treatment) with PDGF or PDGFR inhibitors
3. Dense fibrotic scar or atrophy in the study eye involving the center of the fovea
4. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
5. Prior vitrectomy in the study eye
6. Any history of macular hole of stage 2 and above in the study eye
7. Any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery
8. History of corneal transplant in the study eye
9. Evidence of diabetic retinopathy or diabetic macular edema in either eye
10. Positive serum human chorionic gonadotropin/urine pregnancy test at the screening or baseline visit
50 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Phoenix, Arizona, United States
Tucson, Arizona, United States
Arcadia, California, United States
Beverly Hills, California, United States
Irvine, California, United States
Mountain View, California, United States
Oceanside, California, United States
Sacramento, California, United States
Santa Ana, California, United States
Colorado Springs, Colorado, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
Winter Haven, Florida, United States
Augusta, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Oak Forest, Illinois, United States
Springfield, Illinois, United States
Urbana, Illinois, United States
Iowa City, Iowa, United States
Shawnee Mission, Kansas, United States
Lexington, Kentucky, United States
Paducah, Kentucky, United States
Baltimore, Maryland, United States
Towson, Maryland, United States
Boston, Massachusetts, United States
Jackson, Michigan, United States
Southfield, Michigan, United States
Minneapolis, Minnesota, United States
Florissant, Missouri, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Bloomfield, New Jersey, United States
New Brunswick, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
East Setauket, New York, United States
Great Neck, New York, United States
New York, New York, United States
Orchard Park, New York, United States
Rochester, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Kingston, Pennsylvania, United States
Monroeville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Florence, South Carolina, United States
Ladson, South Carolina, United States
West Columbia, South Carolina, United States
Rapid City, South Dakota, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
Willow Park, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Fairfax, Virginia, United States
Bellevue, Washington, United States
Akita, , Japan
Asahikawa, , Japan
Chiyoda-ku, , Japan
Fukushima, , Japan
Kawasaki, , Japan
Matsumoto, , Japan
Nagasaki, , Japan
Nagoya, , Japan
Osaka, , Japan
Countries
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Other Identifiers
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R2176-3-AMD-1417
Identifier Type: -
Identifier Source: org_study_id
NCT02603484
Identifier Type: -
Identifier Source: nct_alias