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

NCT04126317 | Completed Phase 2 Results FDA Drug

• 1 other identifier: VGFTe (HD)-AMD-1905
• Study Type: interventional
• Target: 106
• Locations: 2 countries
• Sites: 46

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).

Conditions

Neovascular (Wet) Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (3)

• Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)

  Up to Week 44

• Number of Participants With at Least One Serious TEAE

  Up to Week 44

• 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)

  At Week 16

Study Arms (2)

intravitreal aflibercept injection (IAI)

EXPERIMENTAL

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

Drug: aflibercept

High-dose aflibercept (HD)

EXPERIMENTAL

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

Drug: High-dose aflibercept

Interventions

aflibercept DRUG

Intravitreally (IVT) administered as a liquid formulation in a vial

Also known as: EYLEA®, BAY86-5321

intravitreal aflibercept injection (IAI)

High-dose aflibercept DRUG

Intravitreally (IVT) administered as a liquid formulation in a vial

High-dose aflibercept (HD)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Bayer: collaborator

Study Sites (46)

Regeneron Study Site

Phoenix, Arizona, 85020, United States

Location

Regeneron Study Site

Sun City, Arizona, 85351, United States

Location

Regeneron Study Site

Encino, California, 91436, United States

Location

Regeneron Study Site

Fullerton, California, 92835, United States

Location

Regeneron Study Site

Mountain View, California, 94040, United States

Location

Regeneron Study Site

Palm Desert, California, 92211, United States

Location

Regeneron Study Site

Sacramento, California, 95819, United States

Location

Regeneron Study Site

Santa Ana, California, 92705, United States

Location

Regeneron Study Site

Colorado Springs, Colorado, 80909, United States

Location

Regeneron Study Site

Golden, Colorado, 80401, United States

Location

Regeneron Study Site

Waterford, Connecticut, 06385, United States

Location

Regeneron Study Site

Fort Lauderdale, Florida, 33309, United States

Location

Regeneron Study Site

Fort Myers, Florida, 33912, United States

Location

Regeneron Study Site

Lakeland, Florida, 33805, United States

Location

Regeneron Study Site

Largo, Florida, 33770, United States

Location

Regeneron Study Site

Melbourne, Florida, 32901, United States

Location

Regeneron Study Site

Tallahassee, Florida, 32308, United States

Location

Regeneron Study Site

Winter Haven, Florida, 33880, United States

Location

Regeneron Study Site

Augusta, Georgia, 30909, United States

Location

Regeneron Study Site

Marietta, Georgia, 30060, United States

Location

Regeneron Study Site

Oak Forest, Illinois, 60452, United States

Location

Regeneron Study Site

Hagerstown, Maryland, 21740, United States

Location

Regeneron Study Site

Royal Oak, Michigan, 48073, United States

Location

Regeneron Study Site

Bloomfield, New Jersey, 07003, United States

Location

Regeneron Study Site

Teaneck, New Jersey, 07666, United States

Location

Regeneron Study Site

Albuquerque, New Mexico, 87102, United States

Location

Regeneron Study Site

Great Neck, New York, 11021, United States

Location

Regeneron Study Site

Asheville, North Carolina, 28803, United States

Location

Regeneron Study Site

Charlotte, North Carolina, 28210, United States

Location

Regeneron Study Site

Columbus, Ohio, 43212, United States

Location

Regeneron Study Site

Edmond, Oklahoma, 73013, United States

Location

Regeneron Study Site

Portland, Oregon, 97221, United States

Location

Regeneron Study Site

Kingston, Pennsylvania, 18704, United States

Location

Regeneron Study Site

Ladson, South Carolina, 29456, United States

Location

Regeneron Study Site

West Columbia, South Carolina, 29169, United States

Location

Regeneron Study Site

Rapid City, South Dakota, 57701, United States

Location

Regeneron Study Site

Abilene, Texas, 79606, United States

Location

Regeneron Study Site

Arlington, Texas, 76012, United States

Location

Regeneron Study Site

Austin, Texas, 78705, United States

Location

Regeneron Study Site

Houston, Texas, 77030, United States

Location

Regeneron Study Site

The Woodlands, Texas, 77384, United States

Location

Regeneron Study Site

Salt Lake City, Utah, 84107, United States

Location

Regeneron Study Site

Fairfax, Virginia, 22031, United States

Location

Regeneron Study Site

Spokane, Washington, 99204, United States

Location

Regeneron Study Site

Morgantown, West Virginia, 26506, United States

Location

Regeneron Study Site

Arecibo, 00612, Puerto Rico

Location

Related Publications (1)

• Wykoff CC, Brown DM, Reed K, Berliner AJ, Gerstenblith AT, Breazna A, Abraham P, Fein JG, Chu KW, Clark WL, Leal S, Schmelter T, Hirshberg B, Yancopoulos GD, Vitti R; CANDELA Study Investigators. Effect of High-Dose Intravitreal Aflibercept, 8 mg, in Patients With Neovascular Age-Related Macular Degeneration: The Phase 2 CANDELA Randomized Clinical Trial. JAMA Ophthalmol. 2023 Sep 1;141(9):834-842. doi: 10.1001/jamaophthalmol.2023.2421.

  PMID: 37535382 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-masked: The patients, visual acuity examiners, imaging technicians and reading center will be masked to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: November 4, 2019
• Primary Completion: May 14, 2021
• Study Completion: November 30, 2021
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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).

Locations

PR (1); US (45)