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NCT Number: NCT06795048

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Neovascular Age-related Macular Degeneration (nAMD)

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Strathfield Retina Clinic, Strathfield, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Faricimab

Drug

Participants will receive 6-mg faricimab intravitreal (IVT) injections in the study eye according to the dosing regimen for the study arm to which they are randomized.

Other names: RO6867461, VABYSMO®

Primary outcomes

  1. Change from Baseline in Best-Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 44, 48, and 52

    Time frame: Baseline and average of Weeks 44, 48, and 52

Secondary outcomes

  1. Change from Baseline in BCVA Score Averaged Over Weeks 92, 96, and 100

    Time frame: Baseline and average of Weeks 92, 96, and 100

  2. Change from Baseline in BCVA Score Over Time

    Time frame: From Baseline to Week 100

  3. Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time

    Time frame: From Baseline to Week 100

  4. Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time

    Time frame: From Baseline to Week 100

  5. Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time

    Time frame: From Baseline to Week 100

  6. Change from Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44, 48, and 52

    Time frame: Baseline and average of Weeks 44, 48, and 52

  7. Change from Baseline in CST Averaged Over Weeks 92, 96, and 100

    Time frame: Baseline and average of Weeks 92, 96, and 100

  8. Change from Baseline in CST Over Time

    Time frame: From Baseline to Week 100

  9. Percentage of Participants on Different Treatment Intervals at Weeks 52 and 100

    Time frame: Weeks 52 and 100

  10. Incidence and Severity of Ocular Adverse Events

    Time frame: From first study treatment to Week 100

  11. Incidence and Severity of Non-Ocular Adverse Events

    Time frame: From first study treatment to Week 100

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase IIIb/IV, Multicenter, Randomized, Open-Label, Two-Arm Study to Investigate the Efficacy, Safety, and Durability of Faricimab Administered up to Every 24 Weeks in Patients With Neovascular Age-Related Macular Degeneration

Acronym: CONSTANCE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 27, 2025
Registry last updated
Jul 31, 2026

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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