Comparison of Intravitreal Bevacizumab Injection with Combination of Suprachoroidal Triamcinolone Acetonide Along with Intravitreal Bevacizumab Injection in the Treatment of Diabetic Macular Edema in Pseudophakic Patients

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-01-15

Brief Summary

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Patients were included in the study who were pseudophakic with center-involved (sub-foveal) diabetic macular edema

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Detailed Description

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Patients were included in the study who were pseudophakic with center-involved (sub-foveal) diabetic macular edema. Those patients who had glaucoma history or IOP above 21 mm of Hg, Phakic, corneal opacity, vitreous hemorrhage, proliferative diabetic retinopathy, already received anti-VEGF injections, history of pan-retinal photocoagulation for proliferative diabetic retinopathy.

Conditions

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Diabetic Macular Edema (DME)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravitreal Bevacizumab alone for center involving diabetic macular edema

Effect of intravitreal Bevacizumab 1.25mg on center involving diabetic macular edema

Group Type EXPERIMENTAL

Intravitreal Bevacizumab IVB

Intervention Type DRUG

Intravitreal bevacizumab alone

Suprachoroidal triamcinolone acetonide and intravitreal Bevacizumab

Combination of suprachoroidal triamcinolone acetonide and intravitreal Bevacizumab for the treatment of diabetic macular edema

Group Type EXPERIMENTAL

intravitreal bevacizumab and suprachoroidal triamcinolone acetonide

Intervention Type DRUG

Combination of Intravitreal bevacizumab and suprachoroidal triamcinolone acetonide

Interventions

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Intravitreal Bevacizumab IVB

Intravitreal bevacizumab alone

Intervention Type DRUG

intravitreal bevacizumab and suprachoroidal triamcinolone acetonide

Combination of Intravitreal bevacizumab and suprachoroidal triamcinolone acetonide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with center involving diabetic macular edema on optical coherence tomography

Exclusion Criteria

* Raised intraocular pressure
* History of glaucoma
* Corneal opacity
* Vitreous hemorrhage
* Proliferative diabetic retinopathy
* Anti-VEGF injections in last 3 months
* History of pan-retinal photocoagulation
* Contraindications for anti-VEGF

Minimum Eligible Age

32 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No