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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

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