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

Phase 4

Completed

• Conditions: Diabetic Macular Edema (DME)
• Interventions: Drug: Intravitreal Bevacizumab IVB; Drug: intravitreal bevacizumab and suprachoroidal triamcinolone acetonide

• Registration Number: NCT06882551
• Lead Sponsor: Khyber Teaching Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2023-11-30
• Study Completion: 2024-01-15
• Study First Submitted: 2024-11-10
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-16
• Last Update Submitted: 2025-03-16
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravitreal Bevacizumab alone for center involving diabetic macular edema	Intravitreal Bevacizumab IVB	Effect of intravitreal Bevacizumab 1.25mg on center involving diabetic macular edema
Suprachoroidal triamcinolone acetonide and intravitreal Bevacizumab	intravitreal bevacizumab and suprachoroidal triamcinolone acetonide	Combination of suprachoroidal triamcinolone acetonide and intravitreal Bevacizumab for the treatment of diabetic macular edema

Primary Outcome Measures

Name	Time	Method
Central macular thickness	3 months	Effect of both treatment on central macular thickness measure on optical coherence tomography
Visual Acuity	3 months	Improvement in best corrected visual acuity

Trial Locations

Locations (1)

Khyber Teaching Hospital; 🇵🇰 Peshawar, Khyber Pakhtunkhwa, Pakistan