NCT05978622Completed
Observational Study of Adult Participants With Diabetic Macular Edema and Suboptimal Response to Anti-Vascular Endothelial Growth Factor Treated With Dexamethasone Intravitreal Implant
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)
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 236 (actual)
- First submitted
- 31 Jul 2023
- Start date
- 30 Oct 2023
- Primary completion date
- 13 Aug 2026
- Lead sponsor
- AbbVie
- Diseases
- Diabetic eye disease
- NCT number
- NCT05978622
What you commit to
- Study type: Observational
- Participants enrolled: 236
- From 30 Oct 2023 to the primary completion date, 13 Aug 2026
- 54 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any concomitant ocular or neurologic condition in the study eye that could cause macular edema or affect vision (except cataract)
- History of Pan-Retinal Photocoagulation (PRP) or sectorial photocoagulation in the study eye in the 3 months prior to Baseline
- Prior use of intravitreal corticosteroids in the study eye
Other illness
- History of ocular surgery within 60 days of Baseline in the study eye
- Uncontrolled Ocular Hypertension (OHT) or advanced glaucoma in the study 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
Other
- Significant media opacities in the study eye limiting Optical Coherence Tomography (OCT) quality
- Active ocular inflammation in either eye
- Patients with contraindications to DEX-I
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (54)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Saint Pierre /ID# 257650 Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Uza /Id# 255831 Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| Ziekenhuis Oost-Limburg, Campus St.-Jan /ID# 255934 Coordinator of this site? Confirm its status | Genk | Belgium | Unknown status |
| Universitair Ziekenhuis Brussel /ID# 255324 Coordinator of this site? Confirm its status | Jette | Belgium | Unknown status |
| CHR de la Citadelle /ID# 257254 Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Vitaz /Id# 265553 Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Unknown status |
| West China Hospital, Sichuan University /ID# 262745 Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Qingdao Eye Hospital Of Shandong First Medical University /ID# 262756 Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Shenzhen Eye Hospital /ID# 262954 Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Tongji Hospital /ID# 270275 Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Xi'an Fourth Hospital /ID# 262972 Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Augenzentrum Prinz 25 /ID# 261090 Coordinator of this site? Confirm its status | Augsburg | Germany | Unknown status |
| MVZ der Klinik Dardenne GmbH Makulazentrum /ID# 269798 Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| Dres. Schubert/Wissmann /ID# 261598 Coordinator of this site? Confirm its status | Ettlingen | Germany | Unknown status |
| Augenzentrum Frankfurt /ID# 255576 Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Unknown status |
| Augenzentrum Frohe Zukunft /ID# 256290 Coordinator of this site? Confirm its status | Halle | Germany | Unknown status |
| Universitaetsklinikum Leipzig /ID# 255660 Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Augenzentrum Am Johannisplatz /ID# 255754 Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| MVZ Augenzentrum am Berliner Ring /ID# 267412 Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Royal Victoria Hospital /Id# 260232 Coordinator of this site? Confirm its status | Belfast | United Kingdom | Unknown status |
| Bradford Teaching hospitals/ Bradford macular centre /ID# 260909 Coordinator of this site? Confirm its status | Bradford | United Kingdom | Unknown status |
| Gloucestershire Hospitals NHS Foundation Trust /ID# 256886 Coordinator of this site? Confirm its status | Cheltenham | United Kingdom | Unknown status |
| Liverpool University Hospitals NHS Foundation Trust /ID# 260230 Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Moorfields Eye Hospital /ID# 258465 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| East Cheshire NHS Trust /ID# 270263 Coordinator of this site? Confirm its status | Macclesfield | United Kingdom | Unknown status |
| University Hospitals Plymouth NHS Trust /ID# 260908 Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Sunderland Eye Infirmary /ID# 258466 Coordinator of this site? Confirm its status | Sunderland | United Kingdom | Unknown status |
| Great Western Hospital /ID# 258467 Coordinator of this site? Confirm its status | Swindon | United Kingdom | Unknown status |
| University General Hospital of Alexandroupoli /ID# 275850 Coordinator of this site? Confirm its status | Alexandroupoli | Greece | Unknown status |
| Eye Clinic of Athens /ID# 258749 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| University General Hospital Attikon /ID# 257957 Coordinator of this site? Confirm its status | Chaïdári | Greece | Unknown status |
| University General Hospital of Heraklion PA.G.N.I /ID# 258313 Coordinator of this site? Confirm its status | Heraklion | Greece | Unknown status |
| General Hospital of Lamia /ID# 265442 Coordinator of this site? Confirm its status | Lamia | Greece | Unknown status |
| Reg Gen Univ Hosp Larissa /ID# 255235 Coordinator of this site? Confirm its status | Larissa | Greece | Unknown status |
| Papageorgiou General Hospital /ID# 265500 Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Opthalmica SA /ID# 258748 Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Rabin Medical Center /ID# 265476 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Kaplan Medical Center /ID# 265471 Coordinator of this site? Confirm its status | Rehovot | Israel | Unknown status |
| Tel Aviv Sourasky Medical Center /ID# 265469 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Universita Politecnica delle Marche - AOU Ospedali Riuniti di Ancona /ID# 258072 Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 258134 Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| IRCCS Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmologia- ONLUS /ID# 258039 Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Università di Torino /ID# 258442 Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 256293 Coordinator of this site? Confirm its status | Udine | Italy | Unknown status |
| Hospital de Santa Maria Maior, EPE /ID# 261063 Coordinator of this site? Confirm its status | Barcelos | Portugal | Unknown status |
| Unidade Local de Saude da Regiao de Leiria /ID# 262009 Coordinator of this site? Confirm its status | Leiria | Portugal | Unknown status |
| Centro Hospitalar do Baixo Vouga /ID# 264421 Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Unidade Local de Saude de Santo Antonio /ID# 262010 Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Unidade Local de Saude do Estuario do Tejo /ID# 267945 Coordinator of this site? Confirm its status | Vila Franca de Xira | Portugal | Unknown status |
| Kaohsiung Veterans General Hospital /ID# 262429 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Far Eastern Memorial Hospital /ID# 262428 Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| China Medical University Hospital /ID# 262427 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Taiwan University Hospital /ID# 262426 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Linkou Chang Gung Memorial Hospital /ID# 256091 Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.