A multicentre randomised controlled clinical trial testing the non-inferiority of a lighter to the standard initial dosing regimen of faricimab in patients with pretreated neovascular age-related macular degeneration

Moorfields Eye Hospital0 sites230 target enrollmentSeptember 18, 2024

ConditionsNeovascular age-related macular degeneration Eye Diseases

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Neovascular age-related macular degeneration
Sponsor: Moorfields Eye Hospital
Enrollment: 230
Primary Endpoint: Change in best corrected visual acuity (BCVA) from baseline to an average of Week 52 and Week 56, as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a distance of 4 meters
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 18, 2024

End Date

January 4, 2027

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

Moorfields Eye Hospital

Eligibility Criteria

Inclusion Criteria

•Patients aged 50 years or older
•Patients must have macular neovascularization secondary to neovascular age-related macular degeneration (nAMD) in the study eye.
•The study eye must have been previously treated with anti-angiogenic treatment (excluding faricimab) and undergone an initial induction phase of three monthly injections.
•The study eye could not extend treatment interval beyond 12 weeks due to neovascular exudative activity, which includes intra- or submacular fluid, subretinal hyperreflective material (SHRM), or hemorrhage.
•Best corrected visual acuity (BCVA) must be at least 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters.
•Patients must have the ability and willingness to undertake all scheduled visits and assessments.

Exclusion Criteria

•Individuals who have not previously received anti-angiogenic treatment.
•Prior administration of faricimab to the study eye.
•Presence of fibrosis or atrophy in the central 1 mm of the ETDRS grid, active ocular inflammation, or infection in the study eye.
•Tractional retinal detachment, preretinal fibrosis, or macular thickening secondary to an epiretinal membrane or vitreomacular traction affecting the macular architecture.
•Any current or history of ocular disease other than nAMD that may confound assessment of the macula or affect central vision in the study eye.
•Presence of uncontrolled glaucoma.
•Any intraocular surgery within 3 months prior to randomization.
•Females who are pregnant, breastfeeding, or intending to become pregnant during the study period.
•Systolic blood pressure greater than 180 mmHg or diastolic pressure greater than 100 mmHg at rest.
•History of stroke or myocardial infarction within the last 6 months.

Outcomes

Primary Outcomes

Change in best corrected visual acuity (BCVA) from baseline to an average of Week 52 and Week 56, as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a distance of 4 meters

Secondary Outcomes

Measured at Baseline, Week 20 and Week 56:1. Efficacy on additional BCVA outcomes 2. Efficacy of anatomic outcome measures 3. Frequency of treatment administration 4. Safety outcomes 5. Patient-reported outcomes (PROs), including the visual function questionnaire 25 (VFQ25), EuroQol 5D (EQ5D), attitude towards injection burden