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
March 16, 2025 updated by: Imran Ahmad, Khyber Teaching Hospital
Patients were included in the study who were pseudophakic with center-involved (sub-foveal) diabetic macular edema
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
82
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Khyber Pakhtunkhwa
-
Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
- Khyber Teaching Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intravitreal Bevacizumab alone for center involving diabetic macular edema
Effect of intravitreal Bevacizumab 1.25mg on center involving diabetic macular edema
|
Intravitreal bevacizumab alone
|
|
Experimental: Suprachoroidal triamcinolone acetonide and intravitreal Bevacizumab
Combination of suprachoroidal triamcinolone acetonide and intravitreal Bevacizumab for the treatment of diabetic macular edema
|
Combination of Intravitreal bevacizumab and suprachoroidal triamcinolone acetonide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Central macular thickness
Time Frame: 3 months
|
Effect of both treatment on central macular thickness measure on optical coherence tomography
|
3 months
|
|
Visual Acuity
Time Frame: 3 months
|
Improvement in best corrected visual acuity
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Actual)
November 30, 2023
Study Completion (Actual)
January 15, 2024
Study Registration Dates
First Submitted
November 10, 2024
First Submitted That Met QC Criteria
March 16, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 16, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Diseases
- Retinal Degeneration
- Macular Degeneration
- Edema
- Macular Edema
- Antineoplastic Agents, Immunological
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Enzyme Inhibitors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- KhyberTeH
- 450/DME/KMC (Other Identifier: Instititional Ethical and Review Board (IERB))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.