Refractory diabetic macular edema
Conditions
Interventions
Faricimab Group:After enrolment into the study, at least 3intravitreal faricimab injections will be performed every4 weeks, at baseline,4and8weeks.Onweek12 visit onwards,patients will be reviewed ever
Steroid treatment Group:After enrolment into the study, patient will undergo 1 intravitreal dexamethasone implant injection. Patient will be re-assessed at 12, 24 and 36 weeks. If persistent edemais a
Sponsors
Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participant 1.Individuals aged 18 years or older; 2.With type 1 or type 2 DM; 3.Center involved DME (defined as retinal thickening within central 1mm subfield on OCT); 4.Impaired vision as a result of DME, defined as Snellen visual acuity (VA) worse than 20/30. Study eye 1.BCVA = 20/320; 2.CI-DME with CST on OCT >=305um women; >= 320um men (Spectralis,Heidelberg); 3.Received at least 3 injections of 1st line anti-VEGF therapy (aflibercept and ranibizumab) in the past 16 weeks; 4.Poor response to treatment, defined as <20% reduction in CST on OCT or < 5 letters gain in BCVA.
Exclusion criteria
Exclusion criteria: 1.Macular pathology other than DME, such as age-related macular degeneration, macular hole and existing macular scar; 2.Retinopathy other than diabetic retinopathy, such as central retinal vein occlusion and retinitis pigmentosa; 3.Significant media opacities (such as mature cataract) that affect the quality of OCT images acquisition; 4.Contraindications to intravitreal faricimab injection, such as recent ischemic cerebrovascular accidents and ischemic heart disease within 3 months; 5.Patients unfit for giving informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association between OCT and OCTA based parameters and the BCVA and change in BCVA at 52nd week compared to baseline;Association between OCT and OCTA based parameters and change in CST at 52nd week compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional success: defined as improvement of BCVA at week 52 follow up from baseline by 10 ETDRS letters or more;Anatomical success: defined as reduction of CST at week 52 from baseline by 20% or more;Improvement of OCT biomarkers;Number of injections during the study period; | — |
Countries
China
Contacts
Public ContactSimon Ka Ho SZETO
Chinese University of Hong Kong
Outcome results
None listed