NCT06882551

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

November 10, 2024

Last Update Submit

March 16, 2025

Conditions

Diabetic Macular Edema (DME)

Keywords

intravitreal bevacizumabsuprachoroidal triamcinolonediabetic macular edema

Outcome Measures

Primary Outcomes (2)

  • Central macular thickness

    Effect of both treatment on central macular thickness measure on optical coherence tomography

    3 months

  • Visual Acuity

    Improvement in best corrected visual acuity

    3 months

Study Arms (2)

Intravitreal Bevacizumab alone for center involving diabetic macular edema

EXPERIMENTAL

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

Drug: Intravitreal Bevacizumab IVB

Suprachoroidal triamcinolone acetonide and intravitreal Bevacizumab

EXPERIMENTAL

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

Drug: intravitreal bevacizumab and suprachoroidal triamcinolone acetonide

Interventions

Intravitreal Bevacizumab IVBDRUG

Intravitreal bevacizumab alone

Intravitreal Bevacizumab alone for center involving diabetic macular edema
intravitreal bevacizumab and suprachoroidal triamcinolone acetonideDRUG

Combination of Intravitreal bevacizumab and suprachoroidal triamcinolone acetonide

Suprachoroidal triamcinolone acetonide and intravitreal Bevacizumab

Eligibility Criteria

Age32 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber Teaching Hospital

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Related Links

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Ophthalmology

Study Record Dates

First Submitted

November 10, 2024

First Posted

March 18, 2025

Study Start

April 1, 2023

Primary Completion

November 30, 2023

Study Completion

January 15, 2024

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)