IVI Aflibercept Before and After Phaco in DME.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pre-Operative Versus Post-Operative Intravitreal Aflibercept Injection for Management of DME in Patients Undergoing Cataract Surgery

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Procedure: Phacoemulsification with IVI of aflibercept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br>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. | Procedure: Phacoemulsification with IVI of aflibercept<br>* IVI was either before or after cataract surgery<br>|
| Active Comparator: group B<br>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. | Procedure: Phacoemulsification with IVI of aflibercept<br>* IVI was either before or after cataract surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resolving of macular edema | change in central macular thickness | Sixth month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of visual acuity | measuring of BCVA | Sixth month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aflibercept; cataract; diabetic macular edema