Diabetic Macular Edema (DME)
Conditions
Interventions
dexamethason implant and intravitreal anti-VEGF injection (aVEGF) 
Sponsors
AbbVie B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Previously untreated DME patients. Male or female, = 18 years of age at time of 1st treatment. Patient treated with either: • DEX-I only for at least 12 months or • aVEGF only for at least 12 months. or • aVEGF and then switched to DEX-I at 3-5 months without change in aVEGF.Initial dose before Sep 30, 2024 Minimum of 12 months of follow-up data. Minimum of 2 OCT scans: • Baseline • At least 1 follow-up scan in the first 6 months after 1st DME treatment Baseline macular edema =350 microns confirmed on Spectralis SD-OCT or equivalent. Minimum of 3 BCVA assessments: • Baseline • 3 months (+/- 6 weeks) • 12 months (+/- 2 months)Baseline BCVA between 23 and 78 ETDRS letters (between 20/32 and 20/230 Snellen).
Exclusion criteria
Exclusion criteria: 10. Eyes with previous intravitreal or laser treatment for DME. 11. Eyes with previous intraocular or periocular corticosteroid for DME. 12. Eyes with other macular disease, causing visual reduction or disturbance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary ObjectiveTo compare proportion of patients gaining =10 Early treatment diabetic retinopathy study (ETDRS) letters Best Corrected Visual Acuity (BCVA) at 3 months in patients treated with DEX-I vs aVEGF when subretinal fluid (SRF) is present at baseline.Primary EndpointBCVA (indicator variable for gaining =10 ETDRS) at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| BCVA (indicator variable for gaining =10 ETDRS) at 3, 6 and 12 months | — |
Countries
Argentina, Austria, Brazil, China, Colombia, Czech Republic, France, Germany, India, Mexico, Netherlands, Portugal, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom, United States
Contacts
Public Contactk Kuijl
AbbVie B.V.
Outcome results
None listed