IVI Aflibercept Before and After Phaco in DME.
Pre-Operative Versus Post-Operative Intravitreal Aflibercept Injection for Management of DME in Patients Undergoing Cataract Surgery
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 4, 2023
CompletedFirst Posted
Study publicly available on registry
February 16, 2023
CompletedFebruary 16, 2023
February 1, 2023
2.9 years
February 4, 2023
February 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
resolving of macular edema
change in central macular thickness
Sixth month
Secondary Outcomes (1)
Improvement of visual acuity
Sixth month
Study Arms (2)
group A
ACTIVE COMPARATORPatients 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.
group B
ACTIVE COMPARATORPatients 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.
Interventions
IVI was either before or after cataract surgery
Eligibility Criteria
You may qualify if:
- \- Diabetic patients with visually significant cataract
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Al Hadi Hospitallead
Study Sites (1)
Ahady Hospital
Al Qādisīyah, Hawally, 123, Kuwait
Related Publications (1)
Khattab AM, Hagras SM, Lotfy NM. Pre-operative versus post-operative intravitreal aflibercept injection for management of DME in patients undergoing cataract surgery. Graefes Arch Clin Exp Ophthalmol. 2023 Nov;261(11):3223-3229. doi: 10.1007/s00417-023-06138-6. Epub 2023 Jun 17.
PMID: 37329361DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- consultant of ophthalmology
Study Record Dates
First Submitted
February 4, 2023
First Posted
February 16, 2023
Study Start
September 1, 2019
Primary Completion
August 1, 2022
Study Completion
December 1, 2022
Last Updated
February 16, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share