Macular edema secondary to Branch Retinal Vein Occlusion MedDRA version: 20.0 Level: PT Classification code 10038907 Term: Retinal vein occlusion System Organ Class: 10015919 - Eye disorders
Conditions
Sponsors
F.Hoffmann La-Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 260 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 260
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 • To evaluate the frequency of faricimab treatment administration • To evaluate the efficacy of faricimab on anatomical outcome measures using optical coherence tomography (OCT) • To evaluate the ocular and systemic safety and tolerability of faricimab • To characterize the systemic pharmacokinetics of faricimab • To evaluate the immune response to faricimab ;Primary end point(s): 1. Change from baseline in BCVA at Week 24 ;Timepoint(s) of evaluation of this end point: 1. Baseline, Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in BCVA at specified timepoints 2. Proportion of patients with an increase from baseline of >= 15 letters in BCVA at Week 24 3. Proportion of patients with an increase from baseline of >= 15, >= 10, >= 5, or > 0 letters in BCVA at specified timepoints 4. Proportion of patients avoiding a loss of >= 15, >= 10, >= 5, or > 0 letters in BCVA from baseline at specified timepoints 5. Proportion of patients achieving >= 84 letters (20/20 Snellen equivalent) in BCVA at specified timepoints 6. Proportion of patients with BCVA Snellen equivalent of 20/40 or better at specified timepoints 7. Proportion of patients with BCVA Snellen equivalent of 20/200 or worse at specified timepoints 8. Change from baseline in CST at specified timepoints 9. Change from baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) composite score at specified timepoints 10. Proportion of patients on a Q4W, every 8 weeks (Q8W), every 12 weeks (Q12W), or Q16W treatment interval at Week 72 11. Number of study drug injections received from Week 24 through Week 72 12. Incidence and severity of ocular adverse events, with severity determined according to Adverse Event Severity Grading Scale 13. Incidence and severity of non-ocular adverse events, with severity determined according to Adverse Event Severity Grading Scale 14. Plasma concentration of faricimab over time 15. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study ;Timepoint(s) of evaluation of this end point: 1-9. Part I: Baseline to Week 24, Part II: From Week 24 to Week 72 10. At Week 72 11. From Week 24 through Week 72 12.-13. Up to Week 72 14.-15. Day 1, Week 4, 24, 28, 52, 72 | — |
Countries
Argentina, Australia, Austria, Brazil, Czech Republic, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Poland, Portugal, Russian Federation, Singapore, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche LTD
Outcome results
None listed