IVI Aflibercept Before and After Phaco in DME.

February 14, 2023 updated by: Abeer MohamedSadeck Khattab, Al Hadi Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kuwait
    • Hawally
      • Al Qādisīyah, Hawally, Kuwait, 123
        • Ahady Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al Hadi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

February 4, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Estimate)

February 16, 2023

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVI and phaco

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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