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Trial record 1 of 1 for:    NCT04126317
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Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration (CANDELA)

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ClinicalTrials.gov Identifier: NCT04126317
Recruitment Status : Active, not recruiting
First Posted : October 15, 2019
Last Update Posted : October 20, 2021
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
The primary objectives of the study are to determine the safety of high-dose aflibercept (hereafter referred to as HD) and to determine if HD provides greater intraocular pharmacodynamic (PD) effect and/or longer duration of action compared to intravitreal aflibercept injection (hereafter referred to as IAI).

Condition or disease Intervention/treatment Phase
Neovascular (Wet) Age-Related Macular Degeneration Drug: aflibercept Drug: High-dose aflibercept Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Single-masked: The patients, visual acuity examiners, imaging technicians and reading center will be masked to treatment assignment.
Primary Purpose: Treatment
Official Title: A Randomized, Single-Masked, Active-Controlled Phase 2 Study of the Safety, Tolerability, and Efficacy of Repeated Doses of High-Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
Actual Study Start Date : November 4, 2019
Actual Primary Completion Date : May 14, 2021
Estimated Study Completion Date : December 6, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intravitreal aflibercept injection (IAI)
Treatment-naïve patients with neovascular "wet" age-related macular degeneration (nAMD) randomized in a 1:1 ratio
Drug: aflibercept
Intravitreally (IVT) administered as a liquid formulation in a vial
Other Names:
  • EYLEA®
  • BAY86-5321

Experimental: High-dose aflibercept (HD)
Treatment-naïve patients with nAMD randomized in a 1:1 ratio
Drug: High-dose aflibercept
Intravitreally (IVT) administered as a liquid formulation in a vial




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: Up to Week 4 ]
  2. Incidence of serious adverse events (SAEs) [ Time Frame: Up to Week 4 ]
  3. Proportion of patients without retinal fluid in the center subfield [ Time Frame: At week 16 ]
    Presence of retinal fluid is assessed by spectral domain optical coherence tomography (SD-OCT)



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Men or women ≥50 years of age with active subfoveal choroidal neovascularization (CNV) secondary to nAMD
  • Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 78 to 24 (Snellen equivalent of 20/32 to 20/320) in the study eye

Key Exclusion Criteria:

  • Evidence of CNV due to any cause other than nAMD in either eye
  • Evidence of diabetic macular edema (DME) or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients
  • Prior use of IVT anti-VEGF agents (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) in the study eye
  • Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy)
  • Previous use of intraocular or periocular corticosteroids within 120 days of screening or treatment with an IVT steroid implant at any time in the study eye
  • History of vitreoretinal surgery (including scleral buckling) in the study eye
  • Any other intraocular surgery within 12 weeks (84 days) before the screening visit
  • History of corneal transplant or corneal dystrophy in study eye

NOTE: Other protocol defined inclusion/exclusion criteria apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126317


Locations
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United States, Arizona
Regeneron Study Site
Phoenix, Arizona, United States, 85020
Regeneron Study Site
Sun City, Arizona, United States, 85351
United States, California
Regeneron Study Site
Encino, California, United States, 91436
Regeneron Study Site
Fullerton, California, United States, 92835
Regeneron Study Site
Mountain View, California, United States, 94040
Regeneron Study Site
Palm Desert, California, United States, 92211
Regeneron Study Site
Sacramento, California, United States, 95819
Regeneron Study Site
Santa Ana, California, United States, 92705
United States, Colorado
Regeneron Study Site
Colorado Springs, Colorado, United States, 80909
Regeneron Study Site
Golden, Colorado, United States, 80401
United States, Connecticut
Regeneron Study Site
Waterford, Connecticut, United States, 06385
United States, Florida
Regeneron Study Site
Fort Lauderdale, Florida, United States, 33309
Regeneron Study Site
Fort Myers, Florida, United States, 33912
Regeneron Study Site
Lakeland, Florida, United States, 33805
Regeneron Study Site
Largo, Florida, United States, 33770
Regeneron Study Site
Melbourne, Florida, United States, 32901
Regeneron Study Site
Tallahassee, Florida, United States, 32308
Regeneron Study Site
Winter Haven, Florida, United States, 33880
United States, Georgia
Regeneron Study Site
Augusta, Georgia, United States, 30909
Regeneron Study Site
Marietta, Georgia, United States, 30060
United States, Illinois
Regeneron Study Site
Oak Forest, Illinois, United States, 60452
United States, Maryland
Regeneron Study Site
Hagerstown, Maryland, United States, 21740
United States, Michigan
Regeneron Study Site
Royal Oak, Michigan, United States, 48073
United States, New Jersey
Regeneron Study Site
Bloomfield, New Jersey, United States, 07003
Regeneron Study Site
Teaneck, New Jersey, United States, 07666
United States, New Mexico
Regeneron Study Site
Albuquerque, New Mexico, United States, 87102
United States, New York
Regeneron Study Site
Great Neck, New York, United States, 11021
United States, North Carolina
Regeneron Study Site
Asheville, North Carolina, United States, 28803
Regeneron Study Site
Charlotte, North Carolina, United States, 28210
United States, Ohio
Regeneron Study Site
Columbus, Ohio, United States, 43212
United States, Oklahoma
Regeneron Study Site
Edmond, Oklahoma, United States, 73013
United States, Oregon
Regeneron Study Site
Portland, Oregon, United States, 97221
United States, Pennsylvania
Regeneron Study Site
Kingston, Pennsylvania, United States, 18704
United States, South Carolina
Regeneron Study Site
Ladson, South Carolina, United States, 29456
Regeneron Study Site
West Columbia, South Carolina, United States, 29169
United States, South Dakota
Regeneron Study Site
Rapid City, South Dakota, United States, 57701
United States, Texas
Regeneron Study Site
Abilene, Texas, United States, 79606
Regeneron Study Site
Arlington, Texas, United States, 76012
Regeneron Study Site
Austin, Texas, United States, 78705
Regeneron Study Site
Houston, Texas, United States, 77030
Regeneron Study Site
The Woodlands, Texas, United States, 77384
United States, Utah
Regeneron Study Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Regeneron Study Site
Fairfax, Virginia, United States, 22031
United States, Washington
Regeneron Study Site
Spokane, Washington, United States, 99204
United States, West Virginia
Regeneron Study Site
Morgantown, West Virginia, United States, 26506
Puerto Rico
Regeneron Study Site
Arecibo, Puerto Rico, 00612
Sponsors and Collaborators
Regeneron Pharmaceuticals
Bayer
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04126317    
Other Study ID Numbers: VGFTe (HD)-AMD-1905
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents