Observational Study of Adult Participants With Diabetic Macular Edema and Suboptimal Response to Anti-Vascular Endothelial Growth Factor Treated With Dexamethasone Intravitreal Implant

Launched by ABBVIE · Jul 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for adults with diabetic macular edema (DME), a condition that causes swelling in the retina due to diabetes. The focus is on patients who haven’t responded well to standard treatments involving anti-vascular endothelial growth factor (anti-VEGF) injections. The treatment being evaluated is a small implant that gradually releases a medication called dexamethasone into the eye. The study aims to see how well this implant works when given to patients who meet certain criteria, including having received between 3 and 9 anti-VEGF injections in the past year without significant improvement.

To participate, individuals must be diagnosed with DME in one eye and have already tried other treatments without success. The study will enroll about 327 participants from around the world, and each participant will be monitored for 18 months following the implant procedure. Importantly, joining this trial does not require any extra procedures beyond the standard care they would receive from their doctor. This means that patients can expect routine follow-up visits to check their progress.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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