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

Diabetic Macular Edema Clinical Trial

Official title:

A Multi-country, Post Marketing Observational Study of DME Patients With Suboptimal Response to Anti-VEGF Who Are Initiated With Dexamethasone Intravitreal Implant (DEX-I)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978622
• Other study ID #: P23-380
• Status: Recruiting
• Start date: October 30, 2023
• Est. completion date: June 13, 2026

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: Andrew Shirlaw
• Phone: 844-663-3742
• Email: andrew.shirlaw[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 327
• Est. completion date: June 13, 2026
• Est. primary completion date: June 13, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Locations

Country	Name	City	State
Belgium	CHU Saint Pierre /ID# 257650	Bruxelles	Bruxelles-Capitale
Belgium	Uza /Id# 255831	Edegem	Antwerpen
Belgium	Ziekenhuis Oost-Limburg /ID# 255934	Genk
Belgium	Universitair Ziekenhuis Brussel /ID# 255324	Jette	Bruxelles-Capitale
Belgium	CHR de la Citadelle /ID# 257254	Liege
China	West China Hospital, Sichuan University /ID# 262745	Chengdu	Sichuan
China	Qingdao Eye Hospital of Shandong First Medical University /ID# 262756	Qingdao
Germany	Augenzentrum Prinz 25 /ID# 261090	Augsburg
Germany	Dres. Schubert/Wissmann /ID# 261598	Ettlingen
Germany	Augenzentrum Frankfurt /ID# 255576	Frankfurt am Main
Germany	Universitaetsklinikum Leipzig /ID# 255660	Leipzig	Sachsen
Greece	Eye Clinic of Athens /ID# 258749	Athens
Greece	University General Hospital Attikon /ID# 257957	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 258313	Heraklion	Kriti
Greece	Reg Gen Univ Hosp Larissa /ID# 255235	Larisa
Greece	Opthalmica SA /ID# 258748	Thessaloniki
Israel	Rabin Medical Center /ID# 265476	Petah Tikva
Italy	Universita Politecnica delle Marche - AOU Ospedali Riuniti di Ancona /ID# 258072	Ancona
Italy	Fondazione Policlinico A. Gemelli /ID# 258134	Rome	Roma
Italy	IRCCS Fondazione Bietti /ID# 258039	Rome	Roma
Portugal	Hospital de Santa Maria Maior, EPE /ID# 261063	Barcelos	Braga
Portugal	Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 262010	Porto
United Kingdom	Royal Victoria Hospital /Id# 260232	Belfast
United Kingdom	Bradford Teaching hospitals/ Bradford macular centre /ID# 260909	Bradford
United Kingdom	Gloucestershire Hospitals NHS Foundation Trust /ID# 256886	Cheltenham	Gloucestershire
United Kingdom	Liverpool Univeristy Hospitals NHS Foundation Trust /ID# 260230	Liverpool
United Kingdom	Moorfields Eye Hospital /ID# 258465	London	London, City Of
United Kingdom	University Hospital Plymouth NHS Trust /ID# 260908	Plymouth	Devon
United Kingdom	Sunderland Eye Infirmary /ID# 258466	Sunderland
United Kingdom	Great Western Hospital /ID# 258467	Swindon

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Belgium,  China,  Germany,  Greece,  Israel,  Italy,  Portugal,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation	Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation	Baseline to 18 Months

External Links

•   Related Info