Light-Touch Study

Phase 3

• Conditions: Neovascular age-related macular degeneration; Eye Diseases

• Registration Number: ISRCTN10012824
• Lead Sponsor: Moorfields Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-09-18
• Last Update Posted: 30 September 2024
• Study Completion: 2027-01-04

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

1. Patients aged 50 years or older2. Patients must have macular neovascularization secondary to neovascular age-related macular degeneration (nAMD) in the study eye. 3. The study eye must have been previously treated with anti-angiogenic treatment (excluding faricimab) and undergone an initial induction phase of three monthly injections. 4. 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. 5. Best corrected visual acuity (BCVA) must be at least 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. 6. Patients must have the ability and willingness to undertake all scheduled visits and assessments.

Exclusion Criteria

1. Individuals who have not previously received anti-angiogenic treatment. 2. Prior administration of faricimab to the study eye. 3. Presence of fibrosis or atrophy in the central 1 mm of the ETDRS grid, active ocular inflammation, or infection in the study eye. 4. Tractional retinal detachment, preretinal fibrosis, or macular thickening secondary to an epiretinal membrane or vitreomacular traction affecting the macular architecture. 5. 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. 6. Presence of uncontrolled glaucoma. 7. Any intraocular surgery within 3 months prior to randomization. 8. Females who are pregnant, breastfeeding, or intending to become pregnant during the study period. 9. Systolic blood pressure greater than 180 mmHg or diastolic pressure greater than 100 mmHg at rest. 10. History of stroke or myocardial infarction within the last 6 months. 11. Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of the investigational drug or might affect interpretation of the results, or renders the patient at high risk for treatment complications.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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