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

Neovascular (Wet) Age-Related Macular Degeneration Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04126317
• Other study ID #: VGFTe (HD)-AMD-1905
• Status: Completed
• Phase: Phase 2
• Start date: November 4, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: July 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 30, 2021
• Est. primary completion date: May 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular (Wet) Age-Related Macular Degeneration

Intervention

Drug:
• aflibercept
Intravitreally (IVT) administered as a liquid formulation in a vial
• High-dose aflibercept
Intravitreally (IVT) administered as a liquid formulation in a vial

Locations

Country	Name	City	State
Puerto Rico	Regeneron Study Site	Arecibo
United States	Regeneron Study Site	Abilene	Texas
United States	Regeneron Study Site	Albuquerque	New Mexico
United States	Regeneron Study Site	Arlington	Texas
United States	Regeneron Study Site	Asheville	North Carolina
United States	Regeneron Study Site	Augusta	Georgia
United States	Regeneron Study Site	Austin	Texas
United States	Regeneron Study Site	Bloomfield	New Jersey
United States	Regeneron Study Site	Charlotte	North Carolina
United States	Regeneron Study Site	Colorado Springs	Colorado
United States	Regeneron Study Site	Columbus	Ohio
United States	Regeneron Study Site	Edmond	Oklahoma
United States	Regeneron Study Site	Encino	California
United States	Regeneron Study Site	Fairfax	Virginia
United States	Regeneron Study Site	Fort Lauderdale	Florida
United States	Regeneron Study Site	Fort Myers	Florida
United States	Regeneron Study Site	Fullerton	California
United States	Regeneron Study Site	Golden	Colorado
United States	Regeneron Study Site	Great Neck	New York
United States	Regeneron Study Site	Hagerstown	Maryland
United States	Regeneron Study Site	Houston	Texas
United States	Regeneron Study Site	Kingston	Pennsylvania
United States	Regeneron Study Site	Ladson	South Carolina
United States	Regeneron Study Site	Lakeland	Florida
United States	Regeneron Study Site	Largo	Florida
United States	Regeneron Study Site	Marietta	Georgia
United States	Regeneron Study Site	Melbourne	Florida
United States	Regeneron Study Site	Morgantown	West Virginia
United States	Regeneron Study Site	Mountain View	California
United States	Regeneron Study Site	Oak Forest	Illinois
United States	Regeneron Study Site	Palm Desert	California
United States	Regeneron Study Site	Phoenix	Arizona
United States	Regeneron Study Site	Portland	Oregon
United States	Regeneron Study Site	Rapid City	South Dakota
United States	Regeneron Study Site	Royal Oak	Michigan
United States	Regeneron Study Site	Sacramento	California
United States	Regeneron Study Site	Salt Lake City	Utah
United States	Regeneron Study Site	Santa Ana	California
United States	Regeneron Study Site	Spokane	Washington
United States	Regeneron Study Site	Sun City	Arizona
United States	Regeneron Study Site	Tallahassee	Florida
United States	Regeneron Study Site	Teaneck	New Jersey
United States	Regeneron Study Site	The Woodlands	Texas
United States	Regeneron Study Site	Waterford	Connecticut
United States	Regeneron Study Site	West Columbia	South Carolina
United States	Regeneron Study Site	Winter Haven	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Bayer

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)		Up to Week 44
Primary	Number of Participants With at Least One Serious TEAE		Up to Week 44
Primary	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