To compare the proportions of patients with absence of DME (defined by central subfield thickness (CST) less than 325 micron by Spectral domain optical coherence tomography (SD OCT) (Heidelberg Spectralis) after treatment between continuous aflibercept and faricimab-switching groups in DME patients with suboptimal responses to initial aflibercept therapy faricimab aflibercept diabetic macular edema suboptimal
Conditions
Interventions
patients with absence of diabetic macular edema (DME) after faricimab-switching treatment,patients with absence of diabetic macular edema (DME) after continuous aflibercept treatment
Active Comparator Drug,Placebo Comparator Drug
faricimab,aflibercept
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Patients with age at least 18 years old 2) Patients with center-involved diabetic macular edema (DME) with suboptimal response to at least 3 consecutive afliber-cept injections in the last 4 months (defined as persistent CST more than 325 micron by Spectral domain optical coherence tomography (SD OCT) (Heidelberg Spectralis) at 4-6 weeks after the last aflibercept injection) 3) Visual acuity 6/7.5 to 6/240 (20/25 to 20/800) 4) If both eyes are eligible, only the right eye will be included.
Exclusion criteria
Exclusion criteria: 1) Patients with other ocular diseases that might affect the central subfield thickness (CST) such as retinal vein occlu-sion, vitreomacular traction, significant epiretinal membrane, macular hole, choroidal neovascu-larization and taking medication known to cause macular edema. 2) Patients with active proliferative diabetic retinopathy and neovascular glaucoma 3) Patients with history of intraocular surgery within 6 months prior to enrollment 4) Patients with ocular media opacity precluding adequate optical coherence tomography (OCT) image acquisition. 5) Patients who cannot adhere to the research protocol. 6) Patients contraindicated to receiving aflibercept or faricimab such as ocular infection, recent stroke and myocardial infarction within 6 months. 7) Pregnant women (All women in reproductive age will be assessed by asking last menstruation date and current contraception. If there are risks of being pregnant, the patient will be asked to have a urine pregnancy test and to maintain strict contraception throughout the research).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| compare the proportions of patients with absence of diabetic macular edema (DME) after treatment First visit, 4 week, 8 week, 12 week after after treatment compare between aflibercept and faricimab groups by photo from Spectral domain optical coherence tomography (SD OCT) (Heidelberg Spectralis) | — |
Secondary
| Measure | Time frame |
|---|---|
| compare mean change in visual acuity (VA) and central subfield thickness (CST) First visit, 4 week, 8 week, 12 week after after treatment compare between aflibercept and faricimab groups by photo from Spectral domain optical coherence tomography (SD OCT) (Heidelberg Spectralis),compare the changes in visual acuity (VA) and central subfield thickness (CST) First visit, 4 week, 8 week, 12 week after after treatment compare between aflibercept and faricimab groups over time by photo from Spectral domain optical coherence tomography (SD OCT) (Heidelberg Spectralis),compare proportions of patients with subretinal fluid or intraretinal fluid First visit, 4 week, 8 week, 12 week after after treatment compare between aflibercept and faricimab groups by photo from Spectral domain optical coherence tomography (SD OCT) (Heidelberg Spectralis),study clinical and optical coherence tomography (OCT) characteristics associated with responsiveness to faricimab First visit, 4 week, 8 week, 12 week after after treatment photo from Spectral domain optical coherence tomography (SD OCT) (Heidelberg Spectralis) | — |
Countries
Thailand
Contacts
Public ContactNopasak Phasukkijwatana
Faculty of Medicine Siriraj Hospital
Outcome results
None listed