A Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Macular Edema Secondary to Branch Retinal Vein Occlusio
- Conditions
- Macular edema secondary to Branch Retinal Vein OcclusionMedDRA version: 20.0Level: PTClassification code 10038907Term: Retinal vein occlusionSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2020-000440-63-CZ
- Lead Sponsor
- F.Hoffmann La-Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 570
• Age >= 18 years
• Ability to comply with the study protocol
• For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment
• Foveal center–involved macular edema due to branch retinal vein occlusion (BRVO)
• Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent) on Day 1
• Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 285
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 285
• Any major illness or major surgical procedure within 1 month before screening
• Uncontrolled blood pressure
• Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
• Pregnant or breastfeeding, or intending to become pregnant during the study
Ocular Exclusion Criteria for Study Eye
? History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening
? Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye
? Macular laser (focal/grid) in the study eye at any time prior to Day 1
? Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1
? Any prior or current treatment for macular edema; macular neovascularization, including DME and nAMD; and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection
? Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheatotomy
? Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)
Ocular Exclusion Criteria for Both Eyes
• Prior IVT administration of faricimab in either eye
• History of idiopathic or autoimmune-associated uveitis in either eye
• Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To evaluate the efficacy of faricimab 6 mg intravitreal (IVT) injections on best corrected visual acuity (BCVA) outcomes;Secondary Objective: • To evaluate the efficacy of faricimab on additional BCVA outcomes<br>• To evaluate the frequency of faricimab treatment administration<br>• To evaluate the efficacy of faricimab on anatomical outcome measures using optical coherence tomography (OCT)<br>• To evaluate the ocular and systemic safety and tolerability of faricimab<br>• To characterize the systemic pharmacokinetics of faricimab<br>• To evaluate the antibody immune response to faricimab<br><br><br>;Primary end point(s): 1. Change from baseline in BCVA at Week 24<br><br><br>;Timepoint(s) of evaluation of this end point: 1. Baseline, Week 24
- Secondary Outcome Measures
Name Time Method