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The trial is taking place at:
A

Adelaide Eye and Retina Centre | Adelaide, South Australia

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A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (CONSTANCE)

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Roche

Status and phase

Enrolling
Phase 4

Conditions

Neovascular Age-related Macular Degeneration (nAMD)

Treatments

Drug: Faricimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06795048
MR45638
2024-517545-13-00 (Registry Identifier)

Details and patient eligibility

About

This study is a Phase IIIb/IV, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (nAMD) that are treatment-naïve in the study eye.

Enrollment

274 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Overtly healthy as determined by medical evaluation that includes medical history and physical examination
  • Agreement to adhere to the contraception requirements described in the protocol

Ocular Inclusion Criteria for Study Eye:

  • Active treatment-naïve macular neovascularization (MNV) secondary to age-related macular degeneration (AMD), confirmed by the investigator based on the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield on optical coherence tomography (OCT)
  • BCVA of 83 to 24 letters, inclusive (20/25 to 20/320 approximate Snellen equivalent, using the early treatment diabetic retinopathy study [ETDRS] protocol and addressed at the initial testing distance of 4 meters on Day 1)
  • Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis

Exclusion criteria

Ocular Exclusion Criteria for Study Eye:

  • MNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis
  • Retinal pigment epithelial tear involving the macula on Day 1
  • Current vitreous hemorrhage on Day 1
  • Prior periocular pharmacological or IVT treatment (including faricimab, anti-vascular endothelial growth factor [VEGF], or complement inhibitor medication) for other retinal diseases

Ocular Exclusion Criteria for Fellow (Non-Study) Eye:

  • Participants who have a nonfunctioning fellow (non-study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non-study eye (i.e., monocular), at both the screening and study Day 1 visits

Ocular Exclusion for Both Eyes:

  • History of idiopathic or autoimmune associated uveitis in either eye
  • Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

274 participants in 2 patient groups

Arm A: Faricimab Early Treat & Extend Regimen
Experimental group
Treatment:
Drug: Faricimab
Arm B: Faricimab Modified Treat & Extend Regimen
Experimental group
Treatment:
Drug: Faricimab

Trial contacts and locations

28

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Central trial contact

Reference Study ID Number: MR45638 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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