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

July 21, 2023 updated by: Regeneron Pharmaceuticals

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Regeneron Study Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Regeneron Study Site
      • Sun City, Arizona, United States, 85351
        • Regeneron Study Site
    • California
      • 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
        • Regeneron Study Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Regeneron Study Site
      • Golden, Colorado, United States, 80401
        • Regeneron Study Site
    • Connecticut
      • Waterford, Connecticut, United States, 06385
        • Regeneron Study Site
    • Florida
      • 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
        • Regeneron Study Site
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Regeneron Study Site
      • Marietta, Georgia, United States, 30060
        • Regeneron Study Site
    • Illinois
      • Oak Forest, Illinois, United States, 60452
        • Regeneron Study Site
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Regeneron Study Site
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Regeneron Study Site
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Regeneron Study Site
      • Teaneck, New Jersey, United States, 07666
        • Regeneron Study Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Regeneron Study Site
    • New York
      • Great Neck, New York, United States, 11021
        • Regeneron Study Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Regeneron Study Site
      • Charlotte, North Carolina, United States, 28210
        • Regeneron Study Site
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Regeneron Study Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Regeneron Study Site
    • Oregon
      • Portland, Oregon, United States, 97221
        • Regeneron Study Site
    • Pennsylvania
      • Kingston, Pennsylvania, United States, 18704
        • Regeneron Study Site
    • South Carolina
      • Ladson, South Carolina, United States, 29456
        • Regeneron Study Site
      • West Columbia, South Carolina, United States, 29169
        • Regeneron Study Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Regeneron Study Site
    • Texas
      • 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
        • Regeneron Study Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Regeneron Study Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Regeneron Study Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Regeneron Study Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Regeneron Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:
  • BAY86-5321
  • EYLEA®
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Time Frame: Up to Week 44
Up to Week 44
Number of Participants With at Least One Serious TEAE
Time Frame: Up to Week 44
Up to Week 44
Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye
Time Frame: At Week 16
Center subfield=the circular area in 1 millimeter (mm) diameter centered around the center point of the fovea. Without fluid defined as absence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) in the center subfield. Presence of retinal fluid was assessed by spectral domain optical coherence tomography (SD-OCT)
At Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Bayer

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2019

Primary Completion (Actual)

May 14, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 11, 2019

First Posted (Actual)

October 15, 2019

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGFTe (HD)-AMD-1905

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing 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.

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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