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

NCT05978622 | Active Not Recruiting

• 1 other identifier: P23-380
• Study Type: observational
• Target: 236
• Locations: 9 countries
• Sites: 54

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.

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema; DME; Dexamethasone; Dexamethasone Intravitreal Implant; Ozurdex

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Dexamethasone Intravitreal Implant (DEX-I)

Dexamethasone 700 μg intravitreal implant (DEX-I) administered according to general clinical practice.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with diabetic macular edema and sub-optimal response to anti-VEGF therapy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (54)

Uza /Id# 255831

Edegem, Antwerpen, 2650, Belgium

Location

CHU Saint Pierre /ID# 257650

Brussels, Brussels Capital, 1000, Belgium

Location

Universitair Ziekenhuis Brussel /ID# 255324

Jette, Brussels Capital, 1090, Belgium

Location

Ziekenhuis Oost-Limburg, Campus St.-Jan /ID# 255934

Genk, Limburg, 3600, Belgium

Location

Vitaz /Id# 265553

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

Location

CHR de la Citadelle /ID# 257254

Liège, 4000, Belgium

Location

Shenzhen Eye Hospital /ID# 262954

Shenzhen, Guangdong, 518034, China

Location

Tongji Hospital /ID# 270275

Wuhan, Hubei, 430030, China

Location

Xi'an Fourth Hospital /ID# 262972

Xi'an, Shaanxi, 710004, China

Location

Qingdao Eye Hospital Of Shandong First Medical University /ID# 262756

Qingdao, Shandong, 266071, China

Location

West China Hospital, Sichuan University /ID# 262745

Chengdu, Sichuan, 610041, China

Location

MVZ Augenzentrum am Berliner Ring /ID# 267412

Würzburg, Bavaria, 97080, Germany

Location

MVZ der Klinik Dardenne GmbH Makulazentrum /ID# 269798

Bonn, North Rhine-Westphalia, 53177, Germany

Location

Universitaetsklinikum Leipzig /ID# 255660

Leipzig, Saxony, 04103, Germany

Location

Augenzentrum Prinz 25 /ID# 261090

Augsburg, 86150, Germany

Location

Dres. Schubert/Wissmann /ID# 261598

Ettlingen, 76275, Germany

Location

Augenzentrum Frankfurt /ID# 255576

Frankfurt am Main, 60549, Germany

Location

Augenzentrum Frohe Zukunft /ID# 256290

Halle, 06118, Germany

Location

Augenzentrum Am Johannisplatz /ID# 255754

Leipzig, 04103, Germany

Location

University General Hospital Attikon /ID# 257957

Athens, Attica, 12462, Greece

Location

University General Hospital of Heraklion PA.G.N.I /ID# 258313

Heraklion, Crete, 71500, Greece

Location

University General Hospital of Alexandroupoli /ID# 275850

Alexandroupoli, Evros, 68100, Greece

Location

Eye Clinic of Athens /ID# 258749

Athens, 10672, Greece

Location

General Hospital of Lamia /ID# 265442

Lamia, 35100, Greece

Location

Reg Gen Univ Hosp Larissa /ID# 255235

Larissa, 41110, Greece

Location

Opthalmica SA /ID# 258748

Thessaloniki, 54643, Greece

Location

Papageorgiou General Hospital /ID# 265500

Thessaloniki, 56429, Greece

Location

Rabin Medical Center /ID# 265476

Petah Tikva, Central District, 4941492, Israel

Location

Kaplan Medical Center /ID# 265471

Rehovot, Central District, 7660101, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 265469

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 258134

Rome, Roma, 00168, Italy

Location

IRCCS Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmologia- ONLUS /ID# 258039

Rome, Roma, 00184, Italy

Location

Universita Politecnica delle Marche - AOU Ospedali Riuniti di Ancona /ID# 258072

Ancona, 60126, Italy

Location

Università di Torino /ID# 258442

Torino, 10124, Italy

Location

ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 256293

Udine, 33100, Italy

Location

Hospital de Santa Maria Maior, EPE /ID# 261063

Barcelos, Braga District, 4750-275, Portugal

Location

Unidade Local de Saude da Regiao de Leiria, EPE /ID# 262009

Leiria, 2410-197, Portugal

Location

Centro Hospitalar do Baixo Vouga /ID# 264421

Porto, 3814-501, Portugal

Location

Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 262010

Porto, 4099-003, Portugal

Location

Unidade Local de Saude do Estuario do Tejo, EPE /ID# 267945

Vila Franca de Xira, 2600-009, Portugal

Location

National Taiwan University Hospital /ID# 262426

Taipei City, Taipei, 100, Taiwan

Location

Kaohsiung Veterans General Hospital /ID# 262429

Kaohsiung City, 813, Taiwan

Location

Far Eastern Memorial Hospital /ID# 262428

New Taipei City, 22060, Taiwan

Location

China Medical University Hospital /ID# 262427

Taichung, 40447, Taiwan

Location

Linkou Chang Gung Memorial Hospital /ID# 256091

Taoyuan City, 333, Taiwan

Location

East Cheshire NHS Trust /ID# 270263

Macclesfield, Cheshire, SK10 3BL, United Kingdom

Location

Derriford Hospital and the Royal Eye Infirmary /ID# 260908

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Gloucestershire Hospitals NHS Foundation Trust /ID# 256886

Cheltenham, Gloucestershire, GL53 7AN, United Kingdom

Location

Moorfields Eye Hospital /ID# 258465

London, Greater London, EC1V 2PD, United Kingdom

Location

Liverpool University Hospitals NHS Foundation Trust /ID# 260230

Liverpool, Merseyside, L9 7AL, United Kingdom

Location

Royal Victoria Hospital /Id# 260232

Belfast, BT12 6BA, United Kingdom

Location

Bradford Teaching hospitals/ Bradford macular centre /ID# 260909

Bradford, BD5 0JD, United Kingdom

Location

Sunderland Eye Infirmary /ID# 258466

Sunderland, SR2 9HP, United Kingdom

Location

Great Western Hospital /ID# 258467

Swindon, SN3 6BB, United Kingdom

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 7, 2023
• Study Start: October 30, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

GB (9); IL (3); PT (5); BE (6); GR (8); DE (8); TW (5); CN (5); IT (5)