Back to resultsIVI Aflibercept Before and After Phaco in DME.
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
Phacoemulsification with IVI of aflibercept
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Aflibercept; cataract; diabetic macular edema
Eligibility Criteria
Inclusion Criteria: - Diabetic patients with visually significant cataract Exclusion Criteria: previous vitreoretinal surgery laser or intravitreal injections 6 months prior to the procedure intractable glaucom active intra-ocular inflammation retinal detachment vitreous hemorrhage epi-retinal membranes any other retinal vascular or neuroretinal disease. Patients with eventual cataract surgeries
Sites / Locations
- Ahady Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group A
group B
Arm Description
Patients in group A were planned to defer the cataract surgery until receiving two injections of Aflibercept at monthly interval, the third injection was then given intra-operatively.
Patients in group B were planned to undergo cataract surgery first and received the first injection intra-operatively, then received two post-operative injections with a monthly interval.
Outcomes
Primary Outcome Measures
resolving of macular edema
change in central macular thickness
Secondary Outcome Measures
Improvement of visual acuity
measuring of BCVA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05731089
Brief Title
IVI Aflibercept Before and After Phaco in DME.
Official Title
Pre-Operative Versus Post-Operative Intravitreal Aflibercept Injection for Management of DME in Patients Undergoing Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al Hadi Hospital
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To study whether or not cataract surgery should be deferred until treating the co-existing diabetic macular edema (DME) using intravitreal (IVI) anti-vascular endothelial growth factor (anti-VEGF).
Detailed Description
A prospective randomized interventional study included diabetic patients with visually significant cataract and DME. Patients were divided into 2 groups. Group A received three pre-operative intravitreal Aflibercept injections with a monthly interval, the third injection was given intra-operatively. Group B received a single intra-operative injection, and two post-operative injections with a monthly interval. follow up for 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Aflibercept; cataract; diabetic macular edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Active Comparator
Arm Description
Patients in group A were planned to defer the cataract surgery until receiving two injections of Aflibercept at monthly interval, the third injection was then given intra-operatively.
Arm Title
group B
Arm Type
Active Comparator
Arm Description
Patients in group B were planned to undergo cataract surgery first and received the first injection intra-operatively, then received two post-operative injections with a monthly interval.
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification with IVI of aflibercept
Intervention Description
IVI was either before or after cataract surgery
Primary Outcome Measure Information:
Title
resolving of macular edema
Description
change in central macular thickness
Time Frame
Sixth month
Secondary Outcome Measure Information:
Title
Improvement of visual acuity
Description
measuring of BCVA
Time Frame
Sixth month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Diabetic patients with visually significant cataract
Exclusion Criteria:
previous vitreoretinal surgery
laser or intravitreal injections 6 months prior to the procedure
intractable glaucom
active intra-ocular inflammation
retinal detachment
vitreous hemorrhage
epi-retinal membranes
any other retinal vascular or neuroretinal disease.
Patients with eventual cataract surgeries
Facility Information:
Facility Name
Ahady Hospital
City
Al Qādisīyah
State/Province
Hawally
ZIP/Postal Code
123
Country
Kuwait
12. IPD Sharing Statement
Plan to Share IPD
No
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IVI Aflibercept Before and After Phaco in DME.
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