Effectiveness Of Suprachoroidal Injection In Diabetic Macular Edema

Active, not recruiting

• Conditions: Diabetic Macular Edema

• Registration Number: NCT06449768
• Lead Sponsor: Superior University

Brief Summary

It will investigate a novel treatment approach for diabetic macular edema (DME), which causes vision impairment in diabetic patients. It will focuse on the efficacy and safety of administering triamcinolone acetonide via suprachoroidal injection, targeting the space between the sclera and choroid.

Detailed Description

This method aims to enhance drug delivery to the retina, potentially improving outcomes compared to conventional treatments. Participants receive suprachoroidal injections, and the study measures changes in macular thickness and visual acuity. The study's findings could offer a promising alternative to existing DME treatments, aiming to provide better management of the condition and improved patient quality of life.

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-05-01
• Study First Submitted: 2024-05-25
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-03
• Last Update Submitted: 2024-06-03
• Study First Posted: 2024-06-10
• Last Update Posted: 2024-06-10
• Study Completion: 2024-10-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Above 30 years old patients male and female
• Diabetic patient
• Diabetic patient for more than 2 years
• Macular thickness of more than 280um

Exclusion Criteria

• Patient below 30 years
• Patients having media opacity
• Patients with other systemic problems
• Uncooperative patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Optical Coherence Tomography	12 months	OCT is employed to assess changes in macular thickness, providing detailed cross-sectional images of the retina. This non-invasive imaging technique helps quantify the extent of macular edema and monitoring
Visual Acuity Testing	12 Months	Visual acuity testing evaluates the participants' ability to discern letters or symbols at a standardized distance, providing a measure of vision clarity. This tool helps determine the functional improvement in vision.

Trial Locations

Locations (1)

Lions Medical Complex , Main Market, Gulberg ll; 🇵🇰 Lahore, Punjab, Pakistan