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Trial record 3 of 77 for:    Candela

Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration (CANDELA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04126317
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : July 24, 2020
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)
Estimated Enrollment : 100 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 1, 2019
Estimated Primary Completion Date : April 27, 2021
Estimated Study Completion Date : November 7, 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 20 ]
    Presence of retinal fluid is assessed by spectral domain optical coherence tomography (SD-OCT)



Information from the National Library of Medicine

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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


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, California
Regeneron Study Site Recruiting
Fullerton, California, United States, 92835
United States, Colorado
Regeneron Study Site Recruiting
Colorado Springs, Colorado, United States, 80909
United States, Florida
Regeneron Study Site Recruiting
Largo, Florida, United States, 33770
United States, North Carolina
Regeneron Study Site Recruiting
Asheville, North Carolina, United States, 28803
United States, South Carolina
Regeneron Study Site Recruiting
Ladson, South Carolina, United States, 29456
Regeneron Study Site Recruiting
West Columbia, South Carolina, United States, 29169
United States, Washington
Regeneron Study Site Recruiting
Spokane, Washington, United States, 99204
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: July 24, 2020
Last Verified: June 2020
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