Status:
RECRUITING
Observational Study of Adult Participants With Diabetic Macular Edema and Suboptimal Response to Anti-Vascular Endothelial Growth Factor Treated With Dexamethasone Intravitreal Implant
Lead Sponsor:
AbbVie
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Brief Summary
The dexamethasone 700 μg intravitreal implant (DEX-I) delivers dexamethasone gradually to the retina over time. It is an approved drug for the treatment of DME. This study will assess adult participan...
Eligibility Criteria
Inclusion
- Participant diagnosed with DME in the study eye
- Study eye has received at least 3 and no more than 9 anti-VEGF injections in the 12 months prior to DEX-I initiation
- Study eye newly prescribed DEX-I. The prescribing decision lies with the physician and reflects their standard practice
- Participant showing a suboptimal response to anti-VEGF at Baseline in the study eye
Exclusion
- Any concomitant ocular or neurologic condition in the study eye that could cause macular edema or affect vision (except cataract)
- History of ocular surgery within 60 days of Baseline in the study eye
- History of Pan-Retinal Photocoagulation (PRP) or sectorial photocoagulation in the study eye in the 3 months prior to Baseline
- Significant media opacities in the study eye limiting Optical Coherence Tomography (OCT) quality
- Uncontrolled Ocular Hypertension (OHT) or advanced glaucoma in the study eye
- Active ocular inflammation in either eye
- Study eyes that are aphakic with Posterior Capsule Rent (PCR), Anterior Chamber Intraocular Lens (ACIOL), iris or scleral-fixed Intraocular Lens (IOL) or history of complicated cataract surgery with PCR
- Prior use of intravitreal corticosteroids in the study eye
- Patients with contraindications to DEX-I
Key Trial Info
Start Date :
October 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT05978622
Start Date
October 30 2023
End Date
June 1 2026
Last Update
August 5 2025
Active Locations (54)
Enter a location and click search to find clinical trials sorted by distance.
1
Uza /Id# 255831
Edegem, Antwerpen, Belgium, 2650
2
CHU Saint Pierre /ID# 257650
Brussels, Brussels Capital, Belgium, 1000
3
Universitair Ziekenhuis Brussel /ID# 255324
Jette, Brussels Capital, Belgium, 1090
4
Ziekenhuis Oost-Limburg /ID# 255934
Genk, Limburg, Belgium, 3600