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OpenTrials
Completed

NCT Number: NCT04126317

Safety, Tolerability, and Efficacy of 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).

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Key information

Conditions

Neovascular (Wet) Age-related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Regeneron Study Site, Arecibo, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

aflibercept

Drug

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

Other names: EYLEA®, BAY86-5321

High-dose aflibercept

Drug

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

Primary outcomes

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

    Time frame: Up to Week 44

  2. Number of Participants With at Least One Serious TEAE

    Time frame: Up to Week 44

  3. 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)

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Bayer

Registry information

Official study 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

Acronym: CANDELA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 15, 2019
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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