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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone Intravitreal Implant (DEX-I) | Dexamethasone 700 μg intravitreal implant (DEX-I) administered according to general clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with diabetic macular edema and sub-optimal response to anti-VEGF therapy.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uza /Id# 255831 | Edegem | Antwerpen | 2650 | Belgium | ||
| CHU Saint Pierre /ID# 257650 |
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| Brussels |
| Brussels Capital |
| 1000 |
| Belgium |
| Universitair Ziekenhuis Brussel /ID# 255324 | Jette | Brussels Capital | 1090 | Belgium |
| Ziekenhuis Oost-Limburg, Campus St.-Jan /ID# 255934 | Genk | Limburg | 3600 | Belgium |
| Vitaz /Id# 265553 | Sint-Niklaas | Oost-Vlaanderen | 9100 | Belgium |
| CHR de la Citadelle /ID# 257254 | Liège | 4000 | Belgium |
| Shenzhen Eye Hospital /ID# 262954 | Shenzhen | Guangdong | 518034 | China |
| Tongji Hospital /ID# 270275 | Wuhan | Hubei | 430030 | China |
| Xi'an Fourth Hospital /ID# 262972 | Xi'an | Shaanxi | 710004 | China |
| Qingdao Eye Hospital Of Shandong First Medical University /ID# 262756 | Qingdao | Shandong | 266071 | China |
| West China Hospital, Sichuan University /ID# 262745 | Chengdu | Sichuan | 610041 | China |
| MVZ Augenzentrum am Berliner Ring /ID# 267412 | Würzburg | Bavaria | 97080 | Germany |
| MVZ der Klinik Dardenne GmbH Makulazentrum /ID# 269798 | Bonn | North Rhine-Westphalia | 53177 | Germany |
| Universitaetsklinikum Leipzig /ID# 255660 | Leipzig | Saxony | 04103 | Germany |
| Augenzentrum Prinz 25 /ID# 261090 | Augsburg | 86150 | Germany |
| Dres. Schubert/Wissmann /ID# 261598 | Ettlingen | 76275 | Germany |
| Augenzentrum Frankfurt /ID# 255576 | Frankfurt am Main | 60549 | Germany |
| Augenzentrum Frohe Zukunft /ID# 256290 | Halle | 06118 | Germany |
| Augenzentrum Am Johannisplatz /ID# 255754 | Leipzig | 04103 | Germany |
| University General Hospital Attikon /ID# 257957 | Athens | Attica | 12462 | Greece |
| University General Hospital of Heraklion PA.G.N.I /ID# 258313 | Heraklion | Crete | 71500 | Greece |
| University General Hospital of Alexandroupoli /ID# 275850 | Alexandroupoli | Evros | 68100 | Greece |
| Eye Clinic of Athens /ID# 258749 | Athens | 10672 | Greece |
| General Hospital of Lamia /ID# 265442 | Lamia | 35100 | Greece |
| Reg Gen Univ Hosp Larissa /ID# 255235 | Larissa | 41110 | Greece |
| Opthalmica SA /ID# 258748 | Thessaloniki | 54643 | Greece |
| Papageorgiou General Hospital /ID# 265500 | Thessaloniki | 56429 | Greece |
| Rabin Medical Center /ID# 265476 | Petah Tikva | Central District | 4941492 | Israel |
| Kaplan Medical Center /ID# 265471 | Rehovot | Central District | 7660101 | Israel |
| Tel Aviv Sourasky Medical Center /ID# 265469 | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 258134 | Rome | Roma | 00168 | Italy |
| IRCCS Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmologia- ONLUS /ID# 258039 | Rome | Roma | 00184 | Italy |
| Universita Politecnica delle Marche - AOU Ospedali Riuniti di Ancona /ID# 258072 | Ancona | 60126 | Italy |
| Università di Torino /ID# 258442 | Torino | 10124 | Italy |
| ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 256293 | Udine | 33100 | Italy |
| Hospital de Santa Maria Maior, EPE /ID# 261063 | Barcelos | Braga District | 4750-275 | Portugal |
| Unidade Local de Saude da Regiao de Leiria, EPE /ID# 262009 | Leiria | 2410-197 | Portugal |
| Centro Hospitalar do Baixo Vouga /ID# 264421 | Porto | 3814-501 | Portugal |
| Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 262010 | Porto | 4099-003 | Portugal |
| Unidade Local de Saude do Estuario do Tejo, EPE /ID# 267945 | Vila Franca de Xira | 2600-009 | Portugal |
| National Taiwan University Hospital /ID# 262426 | Taipei City | Taipei | 100 | Taiwan |
| Kaohsiung Veterans General Hospital /ID# 262429 | Kaohsiung City | 813 | Taiwan |
| Far Eastern Memorial Hospital /ID# 262428 | New Taipei City | 22060 | Taiwan |
| China Medical University Hospital /ID# 262427 | Taichung | 40447 | Taiwan |
| Linkou Chang Gung Memorial Hospital /ID# 256091 | Taoyuan City | 333 | Taiwan |
| East Cheshire NHS Trust /ID# 270263 | Macclesfield | Cheshire | SK10 3BL | United Kingdom |
| Derriford Hospital and the Royal Eye Infirmary /ID# 260908 | Plymouth | Devon | PL6 8DH | United Kingdom |
| Gloucestershire Hospitals NHS Foundation Trust /ID# 256886 | Cheltenham | Gloucestershire | GL53 7AN | United Kingdom |
| Moorfields Eye Hospital /ID# 258465 | London | Greater London | EC1V 2PD | United Kingdom |
| Liverpool University Hospitals NHS Foundation Trust /ID# 260230 | Liverpool | Merseyside | L9 7AL | United Kingdom |
| Royal Victoria Hospital /Id# 260232 | Belfast | BT12 6BA | United Kingdom |
| Bradford Teaching hospitals/ Bradford macular centre /ID# 260909 | Bradford | BD5 0JD | United Kingdom |
| Sunderland Eye Infirmary /ID# 258466 | Sunderland | SR2 9HP | United Kingdom |
| Great Western Hospital /ID# 258467 | Swindon | SN3 6BB | United Kingdom |