Evaluation of Intraoperative Slow-release Dexamethasone Implant for Epiretinal Membrane
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
Epiretinal membrane (ERM) is a commonly encountered vitreoretinal interface anomaly with a prevalence of approximately 10% in the adult population. It is often treated with pars plana vitrectomy (PPV) and membrane peeling when symptomatic. PPV is generally successful at improving visual acuity (VA) and/or metamorphopsia. At times, however, visual recovery can be hindered by macular edema in the post-vitrectomy period. Ozurdex can accelerate the resorption of intraretinal edema and hasten the improvement in the visual acuity. It has been shown to facilitate fluid absorption by both stimulating endogenous adenosine signaling in Muller cells and by down regulating vascular endothelial growth factor production. So, this study aim to investigate the efficacy of Ozurdex implant after PPV in epiretinal membrane eyes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedStudy Start
First participant enrolled
June 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2022
CompletedJune 13, 2022
June 1, 2022
3 months
June 9, 2022
June 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
CMT
central macular thickness
from preoperation to 3 months follow-up
IOP
intraocular pressure
from preoperation to 3 months follow-up
BCVA
best-corrected visual acuity
from preoperation to 3 months follow-up
Study Arms (2)
PPV group
ACTIVE COMPARATOREpiretinal membrane eyes underwent PPV
PPV+implant Group
EXPERIMENTALEpiretinal membrane eyes underwent PPV combined with Ozurdex implant
Interventions
Epiretinal membrane eyes underwent PPV combined with Ozurdex implant
Eligibility Criteria
You may qualify if:
- patients with a visually significant (BCVA\<20/50) idiopathic epiretinal membrane.
- ocular axial length less than 27.00 mm (optical biometry) associated with cataracts.
You may not qualify if:
- concomitant or previous macular diseases (diabetic macular edema, retinal vein occlusion and agerelated macular degeneration).
- secondary epiretinal membrane, other visually significant macular pathology and prior intravitreal triamcinolone acetonide injection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (8)
Reilly G, Melamud A, Lipscomb P, Toussaint B. SURGICAL OUTCOMES IN PATIENTS WITH MACULAR PUCKER AND GOOD PREOPERATIVE VISUAL ACUITY AFTER VITRECTOMY WITH MEMBRANE PEELING. Retina. 2015 Sep;35(9):1817-21. doi: 10.1097/IAE.0000000000000558.
PMID: 25923959BACKGROUNDMao J, Xu Z, Lao J, Chen Y, Xu X, Wu S, Zheng Z, Liu B, Shen L. Assessment of macular microvasculature features before and after vitrectomy in the idiopathic macular epiretinal membrane using a grading system: An optical coherence tomography angiography study. Acta Ophthalmol. 2021 Nov;99(7):e1168-e1175. doi: 10.1111/aos.14753. Epub 2021 Jan 10.
PMID: 33423352BACKGROUNDYang HS, Kim JT, Joe SG, Lee JY, Yoon YH. Postoperative restoration of foveal inner retinal configuration in patients with epiretinal membrane and abnormally thick inner retina. Retina. 2015 Jan;35(1):111-9. doi: 10.1097/IAE.0000000000000276.
PMID: 25102192BACKGROUNDBeer PM, Bakri SJ, Singh RJ, Liu W, Peters GB 3rd, Miller M. Intraocular concentration and pharmacokinetics of triamcinolone acetonide after a single intravitreal injection. Ophthalmology. 2003 Apr;110(4):681-6. doi: 10.1016/S0161-6420(02)01969-3.
PMID: 12689886BACKGROUNDChin HS, Park TS, Moon YS, Oh JH. Difference in clearance of intravitreal triamcinolone acetonide between vitrectomized and nonvitrectomized eyes. Retina. 2005 Jul-Aug;25(5):556-60. doi: 10.1097/00006982-200507000-00002.
PMID: 16077349BACKGROUNDMedeiros MD, Alkabes M, Navarro R, Garcia-Arumi J, Mateo C, Corcostegui B. Dexamethasone intravitreal implant in vitrectomized versus nonvitrectomized eyes for treatment of patients with persistent diabetic macular edema. J Ocul Pharmacol Ther. 2014 Nov;30(9):709-16. doi: 10.1089/jop.2014.0010. Epub 2014 Sep 26.
PMID: 25259834BACKGROUNDBoyer DS, Faber D, Gupta S, Patel SS, Tabandeh H, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex CHAMPLAIN Study Group. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina. 2011 May;31(5):915-23. doi: 10.1097/IAE.0b013e318206d18c.
PMID: 21487341BACKGROUNDLi S, Zeng Q, Zhu L, Liu W, Li Y, Li J, Li X, Zhao M, Qu J. Intraoperative slow-release dexamethasone intravitreal implant (Ozurdex) in epiretinal membrane peeling surgery: a prospective randomized controlled trial. Front Pharmacol. 2023 Sep 1;14:1219861. doi: 10.3389/fphar.2023.1219861. eCollection 2023.
PMID: 37727387DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jinfeng Qu, MD
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2022
First Posted
June 13, 2022
Study Start
June 15, 2022
Primary Completion
September 15, 2022
Study Completion
September 15, 2022
Last Updated
June 13, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share