Evaluation of Intraoperative Slow-release Dexamethasone Implant for Epiretinal Membrane
Primary Purpose
Epiretinal Membrane
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
slow-release dexamethasone implant
Sponsored by
About this trial
This is an interventional treatment trial for Epiretinal Membrane focused on measuring Epiretinal Membrane; Ozurdex; PPV
Eligibility Criteria
Inclusion Criteria:
- patients with a visually significant (BCVA<20/50) idiopathic epiretinal membrane.
- ocular axial length less than 27.00 mm (optical biometry) associated with cataracts.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
PPV group
PPV+implant Group
Arm Description
Epiretinal membrane eyes underwent PPV
Epiretinal membrane eyes underwent PPV combined with Ozurdex implant
Outcomes
Primary Outcome Measures
CMT
central macular thickness
IOP
intraocular pressure
BCVA
best-corrected visual acuity
Secondary Outcome Measures
Full Information
NCT ID
NCT05416827
First Posted
June 9, 2022
Last Updated
June 9, 2022
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05416827
Brief Title
Evaluation of Intraoperative Slow-release Dexamethasone Implant for Epiretinal Membrane
Official Title
Evaluation of Intraoperative Slow-release Dexamethasone Implant Used During Vitrectomy for Epiretinal Membrane
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 15, 2022 (Anticipated)
Primary Completion Date
September 15, 2022 (Anticipated)
Study Completion Date
September 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Small gauge pars plana vitrectomy (PPV) with membrane peeling is used to successfully treat macular epiretinal membranes (ERMs) with a postoperative improvement of visual acuity in the majority of cases. Traditionally, the treatment of ERMs has been performed purely by peeling the membrane mechanically and then waiting for the intraretinal edema to resolve spontaneously. In the last few years, some publications raised the possibility that triamcinolone acetonide (TA),given as an intravitreal injection at the end of surgery, 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. Dexamethasone is a potent synthetic member of the glucocorticoid class of steroid drugs that has anti-inflammatory and immunosuppressant activity 30 times that of cortisol and 6 times that of triamcinolone. As the postoperative cystoid macular edema usually peaks 4 to 6 weeks after surgery the difference in the half life can be significant and explained the results in past publications. While the use of intravitreal TA as an adjuvant to PPV with membrane peel showed conflicting results. Only few publications demonstrated the effectiveness of Ozurdex in the treatment of macular edema in a vitrectomized eye, after ERM removal.So, this study aim to investigate the efficacy of Ozurdex implant after PPV in epiretinal membrane eyes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane
Keywords
Epiretinal Membrane; Ozurdex; PPV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PPV group
Arm Type
Active Comparator
Arm Description
Epiretinal membrane eyes underwent PPV
Arm Title
PPV+implant Group
Arm Type
Experimental
Arm Description
Epiretinal membrane eyes underwent PPV combined with Ozurdex implant
Intervention Type
Procedure
Intervention Name(s)
slow-release dexamethasone implant
Intervention Description
Epiretinal membrane eyes underwent PPV combined with Ozurdex implant
Primary Outcome Measure Information:
Title
CMT
Description
central macular thickness
Time Frame
from preoperation to 3 months follow-up
Title
IOP
Description
intraocular pressure
Time Frame
from preoperation to 3 months follow-up
Title
BCVA
Description
best-corrected visual acuity
Time Frame
from preoperation to 3 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with a visually significant (BCVA<20/50) idiopathic epiretinal membrane.
ocular axial length less than 27.00 mm (optical biometry) associated with cataracts.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinfeng Qu, MD
Phone
+861088326666
Email
Jinfeng_QuPKU@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinfeng Qu, MD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25923959
Citation
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.
Results Reference
background
PubMed Identifier
33423352
Citation
Mao 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.
Results Reference
background
PubMed Identifier
25102192
Citation
Yang 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.
Results Reference
background
PubMed Identifier
12689886
Citation
Beer 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.
Results Reference
background
PubMed Identifier
16077349
Citation
Chin 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.
Results Reference
background
PubMed Identifier
25259834
Citation
Medeiros 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.
Results Reference
background
PubMed Identifier
21487341
Citation
Boyer 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.
Results Reference
background
Learn more about this trial
Evaluation of Intraoperative Slow-release Dexamethasone Implant for Epiretinal Membrane
We'll reach out to this number within 24 hrs