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

Recruiting

• Conditions: Diabetic Macular Edema

• Registration Number: NCT05978622
• Lead Sponsor: AbbVie

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 participants with diabetic macular edema (DME) and suboptimal response to anti-vascular endothelial growth factor therapy that are treated with DEX-I in the routine clinical setting.

Approximately 327 participants who are prescribed DEX-I by their physicians will be enrolled at approximately 40 sites in approximately 10 countries globally.

Participants will be followed for 18 months post-DEX-I implantation according to the routine clinical practice of the prescribing centers. Only one eye per participant will be evaluated in the study.

No additional burden for participants in this trial is expected.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-07
• Study Start: 2023-10-30
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-01
• Last Update Posted: 2025-08-05
• Primary Completion: 2026-06
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 327

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation	Baseline to 18 Months	Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation

Trial Locations

Locations (54)

University General Hospital of Alexandroupoli /ID# 275850; 🇬🇷 Alexandroupoli, Evros, Greece

Tel Aviv Sourasky Medical Center /ID# 265469; 🇮🇱 Tel Aviv, Tel-Aviv, Israel

Uza /Id# 255831; 🇧🇪 Edegem, Antwerpen, Belgium

CHU Saint Pierre /ID# 257650; 🇧🇪 Bruxelles, Bruxelles-Capitale, Belgium

Universitair Ziekenhuis Brussel /ID# 255324; 🇧🇪 Jette, Bruxelles-Capitale, Belgium

Ziekenhuis Oost-Limburg /ID# 255934; 🇧🇪 Genk, Limburg, Belgium

Vitaz /Id# 265553; 🇧🇪 Sint-Niklaas, Oost-Vlaanderen, Belgium

CHR de la Citadelle /ID# 257254; 🇧🇪 Liege, Belgium

Shenzhen Eye Hospital /ID# 262954; 🇨🇳 Shenzhen, Guangdong, China

Tongji Hospital /ID# 270275; 🇨🇳 Wuhan, Hubei, China

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