IVI Aflibercept Before and After Phaco in DME.

Sponsor

Al Hadi Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05731089

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Procedure: Phacoemulsification with IVI of aflibercept	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospectiveprospective

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2019

Actual Primary Completion Date :

Aug 1, 2022

Actual Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group A 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 IVI was either before or after cataract surgery
Active Comparator: group B 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 IVI was either before or after cataract surgery

Arm

Intervention/Treatment

Active Comparator: group A

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

IVI was either before or after cataract surgery

Active Comparator: group B

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

IVI was either before or after cataract surgery

Outcome Measures

Primary Outcome Measures

resolving of macular edema [Sixth month]
change in central macular thickness

Secondary Outcome Measures

Improvement of visual acuity [Sixth month]
measuring of BCVA

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahady Hospital	Al Qādisīyah	Hawally	Kuwait	123

Sponsors and Collaborators

Al Hadi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abeer MohamedSadeck Khattab, consultant of ophthalmology, Al Hadi Hospital

ClinicalTrials.gov Identifier:

NCT05731089

Other Study ID Numbers:

IVI and phaco

First Posted:

Feb 16, 2023

Last Update Posted:

Feb 16, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Abeer MohamedSadeck Khattab, consultant of ophthalmology, Al Hadi Hospital

Aflibercept; cataract; diabetic macular edema

Additional relevant MeSH terms:

Macular Edema

Aflibercept

Study Results

No Results Posted as of Feb 16, 2023