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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Neovascular (Wet) Age-Related Macular Degeneration

Treatments: Drug: aflibercept; Drug: High-dose aflibercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT04126317

VGFTe (HD)-AMD-1905

Details and patient eligibility

About

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).

Enrollment: 106 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

intravitreal aflibercept injection (IAI)

Experimental group

Description:

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

Treatment:

Drug: aflibercept

High-dose aflibercept (HD)

Experimental group

Description:

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

Treatment:

Drug: High-dose aflibercept