Effectiveness Of Suprachoroidal Injection In Diabetic Macular Edema

June 3, 2024 updated by: Muhammad Naveed Babur, Superior University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

36

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

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Lions Medical Complex , Main Market, Gulberg ll

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

Sampling Method

Probability Sample

Study Population

Diabetic Macular Edema patient having Diabetes for more than 2 years

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity Testing
Time Frame: 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.
12 Months
Optical Coherence Tomography
Time Frame: 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Superior University

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)

November 1, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Estimated)

October 28, 2024

Study Registration Dates

First Submitted

May 25, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSRSW/Batch-Fall22/719

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

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.

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