IVI Aflibercept Before and After Phaco in DME.

Not Applicable

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Procedure: Phacoemulsification with IVI of aflibercept

• Registration Number: NCT05731089
• Lead Sponsor: Al Hadi Hospital

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.

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-12-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-04
• Study First Submitted QC: 2023-02-14
• Last Update Submitted: 2023-02-14
• Study First Posted: 2023-02-16
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	Phacoemulsification with IVI of aflibercept	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.
group A	Phacoemulsification with IVI of aflibercept	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.

Primary Outcome Measures

Name	Time	Method
resolving of macular edema	Sixth month	change in central macular thickness

Secondary Outcome Measures

Name	Time	Method
Improvement of visual acuity	Sixth month	measuring of BCVA

Trial Locations

Locations (1)

Ahady Hospital; 🇰🇼 Al Qādisīyah, Hawally, Kuwait