IVI Aflibercept Before and After Phaco in DME.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cataract DME - Peri vs. Intraop

NCT03920878

Diabetic Macular Edema Cataract

WITHDRAWN PHASE2

Treatment of Macular Edema After Cataract Surgery with Subconjunctival Aflibercept

NCT03396861

Irvine-Gass Syndrome

TERMINATED PHASE1

Mean Visual Acuity Changes Following Five Injections of Aflibercept

NCT02645266

Diabetic Macular Edema

ACTIVE_NOT_RECRUITING NA

A Study of the Effect of Different Doses of Difluprednate Eye Drops on the Intraocular Pressure After Phacoemulsification

NCT05649111

Uveitis, Anterior

UNKNOWN PHASE4

Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

NCT00407225

Inflammation

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Macular Edema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Phacoemulsification with IVI of aflibercept

Intervention Type PROCEDURE

IVI was either before or after cataract surgery

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.

Group Type ACTIVE_COMPARATOR

Phacoemulsification with IVI of aflibercept

Intervention Type PROCEDURE

IVI was either before or after cataract surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Phacoemulsification with IVI of aflibercept

IVI was either before or after cataract surgery

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No