Age-Related Macular Degeneration (ARMD) Clinical Trials

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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)

Status: Recruiting
Location: See all (54) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
CHU Saint Pierre /ID# 257650
COMPLETED
Brussels
Uza /Id# 255831
RECRUITING
Edegem
Ziekenhuis Oost-Limburg /ID# 255934
RECRUITING
Genk
Universitair Ziekenhuis Brussel /ID# 255324
RECRUITING
Jette
CHR de la Citadelle /ID# 257254
COMPLETED
Liège
Vitaz /Id# 265553
COMPLETED
Sint-niklaas
China
West China Hospital, Sichuan University /ID# 262745
RECRUITING
Chengdu
Qingdao Eye Hospital Of Shandong First Medical University /ID# 262756
RECRUITING
Qingdao
Shenzhen Eye Hospital /ID# 262954
RECRUITING
Shenzhen
Tongji Hospital /ID# 270275
RECRUITING
Wuhan
Xi'an Fourth Hospital /ID# 262972
RECRUITING
Xi'an
Germany
Augenzentrum Prinz 25 /ID# 261090
RECRUITING
Augsburg
MVZ der Klinik Dardenne GmbH Makulazentrum /ID# 269798
RECRUITING
Bonn
Dres. Schubert/Wissmann /ID# 261598
RECRUITING
Ettlingen
Augenzentrum Frankfurt /ID# 255576
RECRUITING
Frankfurt Am Main
Augenzentrum Frohe Zukunft /ID# 256290
RECRUITING
Halle
Augenzentrum am Johannisplatz /ID# 255754
RECRUITING
Leipzig
Universitaetsklinikum Leipzig /ID# 255660
RECRUITING
Leipzig
MVZ Augenzentrum am Berliner Ring /ID# 267412
RECRUITING
Würzburg
Greece
University General Hospital of Alexandroupoli /ID# 275850
RECRUITING
Alexandroupoli
Eye Clinic of Athens /ID# 258749
RECRUITING
Athens
University General Hospital Attikon /ID# 257957
RECRUITING
Athens
University General Hospital of Heraklion PA.G.N.I /ID# 258313
RECRUITING
Heraklion
General Hospital of Lamia /ID# 265442
RECRUITING
Lamia
Reg Gen Univ Hosp Larissa /ID# 255235
RECRUITING
Larissa
Opthalmica SA /ID# 258748
RECRUITING
Thessaloniki
Papageorgiou General Hospital /ID# 265500
RECRUITING
Thessaloniki
Israel
Rabin Medical Center /ID# 265476
RECRUITING
Petah Tikva
Kaplan Medical Center /ID# 265471
RECRUITING
Rehovot
Tel Aviv Sourasky Medical Center /ID# 265469
RECRUITING
Tel Aviv
Italy
Universita Politecnica delle Marche - AOU Ospedali Riuniti di Ancona /ID# 258072
RECRUITING
Ancona
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 258134
RECRUITING
Rome
IRCCS Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmologia- ONLUS /ID# 258039
RECRUITING
Rome
Università di Torino /ID# 258442
RECRUITING
Torino
ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 256293
RECRUITING
Udine
Portugal
Hospital de Santa Maria Maior, EPE /ID# 261063
RECRUITING
Barcelos
Unidade Local de Saude da Regiao de Leiria, EPE /ID# 262009
RECRUITING
Leiria
Centro Hospitalar do Baixo Vouga /ID# 264421
RECRUITING
Porto
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 262010
RECRUITING
Porto
Unidade Local de Saude do Estuario do Tejo, EPE /ID# 267945
RECRUITING
Vila Franca De Xira
Taiwan
Kaohsiung Veterans General Hospital /ID# 262429
RECRUITING
Kaohsiung City
Far Eastern Memorial Hospital /ID# 262428
RECRUITING
New Taipei City
China Medical University Hospital /ID# 262427
RECRUITING
Taichung
National Taiwan University Hospital /ID# 262426
RECRUITING
Taipei City
Linkou Chang Gung Memorial Hospital /ID# 256091
RECRUITING
Taoyuan
United Kingdom
Royal Victoria Hospital /Id# 260232
COMPLETED
Belfast
Bradford Teaching hospitals/ Bradford macular centre /ID# 260909
COMPLETED
Bradford
Gloucestershire Hospitals NHS Foundation Trust /ID# 256886
RECRUITING
Cheltenham
Liverpool Univeristy Hospitals NHS Foundation Trust /ID# 260230
RECRUITING
Liverpool
Moorfields Eye Hospital /ID# 258465
RECRUITING
London
East Cheshire NHS Trust /ID# 270263
RECRUITING
Macclesfield
Derriford Hospital and the Royal Eye Infirmary /ID# 260908
RECRUITING
Plymouth
Sunderland Eye Infirmary /ID# 258466
RECRUITING
Sunderland
Great Western Hospital /ID# 258467
RECRUITING
Swindon
Contact Information
Primary
Andrew Shirlaw
andrew.shirlaw@abbvie.com
844-663-3742
Time Frame
Start Date: 2023-10-30
Estimated Completion Date: 2026-06
Participants
Target number of participants: 327
Treatments
Dexamethasone Intravitreal Implant (DEX-I)
Dexamethasone 700 μg intravitreal implant (DEX-I) administered according to general clinical practice.
Related Therapeutic Areas
Diabetic Macular Edema (DME)
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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