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NCT05731089 Clinical Trial

IVI Aflibercept Before and After Phaco in DME.

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05731089
Other study ID # IVI and phaco
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date December 1, 2022

Study information
Verified date February 2023
Source Al Hadi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Phacoemulsification with IVI of aflibercept
IVI was either before or after cataract surgery

Locations
Country Name City State
Kuwait Ahady Hospital Al Qadisiyah Hawally

Sponsors (1)
Lead Sponsor Collaborator
Al Hadi Hospital

Country where clinical trial is conducted

Kuwait, 

Outcome
Type Measure Description Time frame Safety issue
Primary resolving of macular edema change in central macular thickness Sixth month
Secondary Improvement of visual acuity measuring of BCVA Sixth month
See also
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Terminated NCT04603937 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
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