Observational Study of Adult Participants With Diabetic Macular Edema and Suboptimal Response to Anti-Vascular Endothelial Growth Factor Treated With Dexamethasone Intravitreal Implant
NCT ID: NCT05978622
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
327 participants
OBSERVATIONAL
2023-10-30
2026-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Dexamethasone Intravitreal Implant (DEX-I)
Dexamethasone 700 μg intravitreal implant (DEX-I) administered according to general clinical practice.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Uza /Id# 255831
Edegem, Antwerpen, Belgium
CHU Saint Pierre /ID# 257650
Brussels, Brussels Capital, Belgium
Universitair Ziekenhuis Brussel /ID# 255324
Jette, Brussels Capital, Belgium
Ziekenhuis Oost-Limburg /ID# 255934
Genk, Limburg, Belgium
Vitaz /Id# 265553
Sint-Niklaas, Oost-Vlaanderen, Belgium
CHR de la Citadelle /ID# 257254
Liège, , Belgium
Shenzhen Eye Hospital /ID# 262954
Shenzhen, Guangdong, China
Tongji Hospital /ID# 270275
Wuhan, Hubei, China
Xi'an Fourth Hospital /ID# 262972
Xi'an, Shaanxi, China
Qingdao Eye Hospital Of Shandong First Medical University /ID# 262756
Qingdao, Shandong, China
West China Hospital, Sichuan University /ID# 262745
Chengdu, Sichuan, China
MVZ Augenzentrum am Berliner Ring /ID# 267412
Würzburg, Bavaria, Germany
MVZ der Klinik Dardenne GmbH Makulazentrum /ID# 269798
Bonn, North Rhine-Westphalia, Germany
Universitaetsklinikum Leipzig /ID# 255660
Leipzig, Saxony, Germany
Augenzentrum Prinz 25 /ID# 261090
Augsburg, , Germany
Dres. Schubert/Wissmann /ID# 261598
Ettlingen, , Germany
Augenzentrum Frankfurt /ID# 255576
Frankfurt am Main, , Germany
Augenzentrum Frohe Zukunft /ID# 256290
Halle, , Germany
Augenzentrum am Johannisplatz /ID# 255754
Leipzig, , Germany
University General Hospital Attikon /ID# 257957
Athens, Attica, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 258313
Heraklion, Crete, Greece
University General Hospital of Alexandroupoli /ID# 275850
Alexandroupoli, Evros, Greece
Eye Clinic of Athens /ID# 258749
Athens, , Greece
General Hospital of Lamia /ID# 265442
Lamia, , Greece
Reg Gen Univ Hosp Larissa /ID# 255235
Larissa, , Greece
Opthalmica SA /ID# 258748
Thessaloniki, , Greece
Papageorgiou General Hospital /ID# 265500
Thessaloniki, , Greece
Rabin Medical Center /ID# 265476
Petah Tikva, Central District, Israel
Kaplan Medical Center /ID# 265471
Rehovot, Central District, Israel
Tel Aviv Sourasky Medical Center /ID# 265469
Tel Aviv, Tel Aviv, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 258134
Rome, Roma, Italy
IRCCS Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmologia- ONLUS /ID# 258039
Rome, Roma, Italy
Universita Politecnica delle Marche - AOU Ospedali Riuniti di Ancona /ID# 258072
Ancona, , Italy
Università di Torino /ID# 258442
Torino, , Italy
ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 256293
Udine, , Italy
Hospital de Santa Maria Maior, EPE /ID# 261063
Barcelos, Braga District, Portugal
Unidade Local de Saude da Regiao de Leiria, EPE /ID# 262009
Leiria, , Portugal
Centro Hospitalar do Baixo Vouga /ID# 264421
Porto, , Portugal
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 262010
Porto, , Portugal
Unidade Local de Saude do Estuario do Tejo, EPE /ID# 267945
Vila Franca de Xira, , Portugal
National Taiwan University Hospital /ID# 262426
Taipei City, Taipei, Taiwan
Kaohsiung Veterans General Hospital /ID# 262429
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital /ID# 262428
New Taipei City, , Taiwan
China Medical University Hospital /ID# 262427
Taichung, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 256091
Taoyuan, , Taiwan
Derriford Hospital and the Royal Eye Infirmary /ID# 260908
Plymouth, Devon, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust /ID# 256886
Cheltenham, Gloucestershire, United Kingdom
Moorfields Eye Hospital /ID# 258465
London, Greater London, United Kingdom
Royal Victoria Hospital /Id# 260232
Belfast, , United Kingdom
Bradford Teaching hospitals/ Bradford macular centre /ID# 260909
Bradford, , United Kingdom
Liverpool Univeristy Hospitals NHS Foundation Trust /ID# 260230
Liverpool, , United Kingdom
East Cheshire NHS Trust /ID# 270263
Macclesfield, , United Kingdom
Sunderland Eye Infirmary /ID# 258466
Sunderland, , United Kingdom
Great Western Hospital /ID# 258467
Swindon, , United Kingdom
Countries
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Central Contacts
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Related Links
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Other Identifiers
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P23-380
Identifier Type: -
Identifier Source: org_study_id
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