Functional and Anatomical Outcomes of Dexamethasone Intra-vitreal Implant in Patients With Resistant Macular Edema Secondary to Retinal Vein Occlusion After Intravitreal Anti-VEGF Injection
Primary Purpose
Macular Edema, Retinal Vein Occlusion
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Intravitreal injection of Dexamethasone implant
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema focused on measuring Dexamethasone Intravitreal Implant, Retinal vein occlusion, Macular Edema
Eligibility Criteria
Inclusion Criteria:
- Patients with macular edema secondary to BRVO and CRVO.
- Presence of macular edema >3oo μ on OCT evaluation.
- visual acuity of +0.3 logarithm of the minimum angle of resolution (logMAR) or worse.
Exclusion Criteria:
- Presence of coexisting retinal disease (such as diabetic retinopathy, age related macular degeneration, vitreo-macular traction, or epiretinal membrane).
- Media opacities (cataract) that could decrease visual acuity (VA).
- Previous ocular trauma or vitreoretinal surgery.
- Patients with glaucoma or known to be steroid responders
Sites / Locations
- Faculty of medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with RVO
Arm Description
Dexamethasone Intravitreal Implant is used in patients with Macular ar edema due to retinal vein occlusion either from the start or after unsatisfactory response to anti - VEGF
Outcomes
Primary Outcome Measures
_Assessment of VA using snellen chart after use of ozurdex in macular edema secondary to RVO.
Secondary Outcome Measures
- To evaluate the incidence and onset of occurrence of any adverse event or recurrence.
Safety of intravitreal Ozurdex injection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05003258
Brief Title
Functional and Anatomical Outcomes of Dexamethasone Intra-vitreal Implant in Patients With Resistant Macular Edema Secondary to Retinal Vein Occlusion After Intravitreal Anti-VEGF Injection
Official Title
Functional and Anatomical Outcomes of Dexamethasone Intra-vitreal Implant in Patients With Resistant Macular Edema Secondary to Retinal Vein Occlusion After Intravitreal Anti-VEGF Injection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Retinal vein occlusion (RVO) is one of the most common causes of vision loss due to retinal vascular disease. Incidence of RVO has been raised in the last years due to increased coexisting systemic vascular risk factors as arterial hypertension, obesity, diabetes mellitus and COVID-19. Macular edema (ME) is a major sight-threatening complication of branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). BRVO and CRVO have the same pathology, an elevation in the intravascular pressure in the occluded vein leading to vascular wall damage causing leakage of fluid and release of inflammatory cytokines as vascular endothelial growth factor (VEGF), respectively.
In the past, the standard treatment for BRVO-related ME was grid laser photocoagulation and for CRVO-related ME was observation. But subsequent randomized controlled trials demonstrated significant functional and anatomical improvements among patients with ME secondary to BRVO or CRVO treated with intravitreal injections of vascular endothelial growth factor (VEGF) inhibitors or corticosteroids compared to those treated with laser only. Anti-VEGF therapy decrease intravenous pressure, enhance blood flow and improve venous diameter and tortuosity. Also, intravitreal corticosteroid injection has been shown to improve vision and central macular thickness (CMT).
Dexamethasone intravitreal implant (Ozurdex®, Allergan Inc., Irvine, CA, USA) has potent antiangiogenic and anti-inflammatory effects. Also it decreases the vascular permeability playing an important role in treating ME secondary to RVO. However, majority of eyes have been treated previously then shifted to dexamethasone implant as a second line for treatment of refractory RVO related ME.
Detailed Description
Aim of the research is To evaluate functional and anatomical outcomes of ozurdex injection in patients with RVO related macular edema.
And evaluation of the safety of ozurdex injections regarding intraocular pressure increase, cataract development or endophthalmitis.
Type of the study: Interventional Case Series. Study Setting: Assiut University Hospital (Ophthalmology Department).
Study subjects:
Inclusion criteria:
Patients with macular edema secondary to BRVO and CRVO.
Presence of macular edema >3oo μ on OCT evaluation.
visual acuity of +0.3 logarithm of the minimum angle of resolution (logMAR) or worse.
Exclusion criteria:
Presence of coexisting retinal disease (such as diabetic retinopathy, age related macular degeneration, vitreo-macular traction, or epiretinal membrane).
Media opacities (cataract) that could decrease visual acuity (VA).
Previous ocular trauma or vitreoretinal surgery.
Patients with glaucoma or known to be steroid responders.
Baseline evaluation:
Complete ophthalmic evaluation including assessment of distance BCVA using Snellen charts and will be converted to logarithm of the minimum angle of resolution (logMAR), tonometry, slit-lamp bio microscopy, gonioscopy and dilated fundus examination.
Thorough clinical history and review of other systems involvement as well as full drug history.
Imaging:
SD-OCT (Spectralis; Heidelberg Engineering, Heidelberg, Germany) with automated CMT measurements through a dilated pupil.
Color fundus photography and fluorescein angiography will be performed for every patient at baseline to document the clinical appearance and type of RVO using Topcon TRC-NW8F (Topcon Medical Systems, Inc., Tokyo, Japan).
OCTA will be performed before and after injection.
Outcome measures:
Primary (main):
Assessment of VA and CMT improvement after use of dexamethasone implant in macular edema secondary to RVO.
Evaluation the safety of intravitreal Ozurdex injection regarding adverse events as IOP increase, cataract development or endophthalmitis.
b. Secondary (subsidiary):
To evaluate the incidence and onset of occurrence of any adverse event or recurrence.
To correlate between BCVA and CMT throughout the duration of the study. Data collection: data will recorded in the form of excel spreadsheets. Computer software: SPSS. Statistical tests: Tests of normality will be performed, if data are normally distributed student t-test will be done and if not, Mann-Whitney test will be done.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Retinal Vein Occlusion
Keywords
Dexamethasone Intravitreal Implant, Retinal vein occlusion, Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with RVO
Arm Type
Other
Arm Description
Dexamethasone Intravitreal Implant is used in patients with Macular ar edema due to retinal vein occlusion either from the start or after unsatisfactory response to anti - VEGF
Intervention Type
Device
Intervention Name(s)
Intravitreal injection of Dexamethasone implant
Other Intervention Name(s)
Ozurdex
Intervention Description
Intravitreal injection of Dexamethasone implant
Primary Outcome Measure Information:
Title
_Assessment of VA using snellen chart after use of ozurdex in macular edema secondary to RVO.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
- To evaluate the incidence and onset of occurrence of any adverse event or recurrence.
Description
Safety of intravitreal Ozurdex injection
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with macular edema secondary to BRVO and CRVO.
Presence of macular edema >3oo μ on OCT evaluation.
visual acuity of +0.3 logarithm of the minimum angle of resolution (logMAR) or worse.
Exclusion Criteria:
Presence of coexisting retinal disease (such as diabetic retinopathy, age related macular degeneration, vitreo-macular traction, or epiretinal membrane).
Media opacities (cataract) that could decrease visual acuity (VA).
Previous ocular trauma or vitreoretinal surgery.
Patients with glaucoma or known to be steroid responders
Facility Information:
Facility Name
Faculty of medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
31564342
Citation
Teja S, Sawatzky L, Wiens T, Maberley D, Ma P. Ozurdex for refractory macular edema secondary to diabetes, vein occlusion, uveitis and pseudophakia. Can J Ophthalmol. 2019 Oct;54(5):540-547. doi: 10.1016/j.jcjo.2018.12.005. Epub 2019 Jan 25.
Results Reference
background
PubMed Identifier
32104597
Citation
Maggio E, Mete M, Maraone G, Attanasio M, Guerriero M, Pertile G. Intravitreal Injections for Macular Edema Secondary to Retinal Vein Occlusion: Long-Term Functional and Anatomic Outcomes. J Ophthalmol. 2020 Feb 13;2020:7817542. doi: 10.1155/2020/7817542. eCollection 2020.
Results Reference
background
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Functional and Anatomical Outcomes of Dexamethasone Intra-vitreal Implant in Patients With Resistant Macular Edema Secondary to Retinal Vein Occlusion After Intravitreal Anti-VEGF Injection
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