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

Primary Purpose

Neovascular (Wet) Age-Related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
aflibercept
High-dose aflibercept
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular (Wet) Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

intravitreal aflibercept injection (IAI)

High-dose aflibercept (HD)

Arm Description

Treatment-naïve patients with neovascular "wet" age-related macular degeneration (nAMD) randomized in a 1:1 ratio

Treatment-naïve patients with nAMD randomized in a 1:1 ratio

Outcomes

Primary Outcome Measures

Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Number of Participants With at Least One Serious TEAE
Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye
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)

Secondary Outcome Measures

Full Information

First Posted
October 11, 2019
Last Updated
July 21, 2023
Sponsor
Regeneron Pharmaceuticals
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT04126317
Brief Title
Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
Acronym
CANDELA
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
May 14, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular (Wet) Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single-masked: The patients, visual acuity examiners, imaging technicians and reading center will be masked to treatment assignment.
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intravitreal aflibercept injection (IAI)
Arm Type
Experimental
Arm Description
Treatment-naïve patients with neovascular "wet" age-related macular degeneration (nAMD) randomized in a 1:1 ratio
Arm Title
High-dose aflibercept (HD)
Arm Type
Experimental
Arm Description
Treatment-naïve patients with nAMD randomized in a 1:1 ratio
Intervention Type
Drug
Intervention Name(s)
aflibercept
Other Intervention Name(s)
EYLEA®, BAY86-5321
Intervention Description
Intravitreally (IVT) administered as a liquid formulation in a vial
Intervention Type
Drug
Intervention Name(s)
High-dose aflibercept
Intervention Description
Intravitreally (IVT) administered as a liquid formulation in a vial
Primary Outcome Measure Information:
Title
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Time Frame
Up to Week 44
Title
Number of Participants With at Least One Serious TEAE
Time Frame
Up to Week 44
Title
Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye
Description
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)
Time Frame
At Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Regeneron Study Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Regeneron Study Site
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Regeneron Study Site
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Regeneron Study Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Regeneron Study Site
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Regeneron Study Site
City
Palm Desert
State/Province
California
ZIP/Postal Code
92211
Country
United States
Facility Name
Regeneron Study Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Regeneron Study Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Regeneron Study Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Regeneron Study Site
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Regeneron Study Site
City
Waterford
State/Province
Connecticut
ZIP/Postal Code
06385
Country
United States
Facility Name
Regeneron Study Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
Regeneron Study Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Regeneron Study Site
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Regeneron Study Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Regeneron Study Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Regeneron Study Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Regeneron Study Site
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Regeneron Study Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Regeneron Study Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Regeneron Study Site
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Facility Name
Regeneron Study Site
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Regeneron Study Site
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Regeneron Study Site
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
Regeneron Study Site
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Regeneron Study Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Regeneron Study Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Regeneron Study Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Regeneron Study Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Regeneron Study Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Regeneron Study Site
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Regeneron Study Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97221
Country
United States
Facility Name
Regeneron Study Site
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Regeneron Study Site
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Regeneron Study Site
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Regeneron Study Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Regeneron Study Site
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Regeneron Study Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Regeneron Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Regeneron Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Regeneron Study Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Regeneron Study Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Regeneron Study Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Regeneron Study Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Regeneron Study Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Regeneron Study Site
City
Arecibo
ZIP/Postal Code
00612
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/

Learn more about this trial

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

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