Macular Edema Following Branch Retinal Vein Occlusion (BRVO) and Central/Hemiretinal Vein Occlusion (C/HRVO)
Conditions
Interventions
Faricimab treatment group:None
Sponsors
The Zhongshan Ophthalmic Center, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: >= 18 years at the time of signing ICF; 2. Informed Consent: Signed Informed Consent Form (ICF); 3. Diagnosis of foveal center–involved macular edema secondary to Branch Retinal Vein Occlusion or Central Retinal or Hemiretinal Vein Occlusion confirmed by the Investigator based on the presence of IRF or SRF on OCT at screening; 4. Patients with RVO who are planning to initiate a Treat-and-Extend (T&E) treatment regimen, and are able and willing to comply with T&E treatment management at the time of enrollment; 5. Patients must be treatment-naïve (never received any anti-VEGF treatment in the study eye) prior to the baseline visit; 6. Patients for whom the decision to receive treatment with faricimab is made prior to and independent from study participation, in accordance with routine clinical practice and local labeling; 7. Ability and willingness to comply with the observational data collection and routine clinic visit schedule; 8. Sufficiently clear ocular media to allow acquisition of good quality retinal images to confirm diagnosis; 9. Patients who have available data for visual acuity (VA) and optical coherence tomography (OCT) assessment from the examination where decision to start treatment with faricimab was taken.
Exclusion criteria
Exclusion criteria: 1. Active ocular inflammation or suspected / active ocular infection in either eye; 2. Received any steroid treatment within 6 months (180 days) before the first faricimab treatment in the study eye; 3. Any participation in any other clinical trials currently; 4. Any history of panretinal photocoagulation (PRP); 5. Patients could not provide the clinical data (visual acuity and OCT images) within 3 weeks (21 days) before receiving the initial faricimab injection; 6. Patients participated in a Roche Patient Support Program (PSP/MAP).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in VA (approximate ETDRS letter score) from baseline at week 48.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of eyes achieving "Dry Macula" (absence of both Intra-retinal Fluid [IRF] and Sub-retinal Fluid [SRF]);Imaging assessments results;VA;Disease information at baseline;Other imaging assessments results;Demographic characteristics;Medical history;Treatment and management during study period;Central subfield thickness (CST);Safety events;Concomitant medications;OCT [SD-OCT or SS-OCT]) results; | — |
Countries
China
Contacts
Public ContactTao Li
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Outcome results
None listed