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NCT06449768 Clinical Trial

Effectiveness Of Suprachoroidal Injection In Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:
Effectiveness Of Suprachoroidal Injection In Diabetic Macular Edema

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06449768
Other study ID # MSRSW/Batch-Fall22/719
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 1, 2023
Est. completion date October 28, 2024

Study information
Verified date June 2024
Source Superior University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 36
Est. completion date October 28, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Diabetic Macular Edema
observing the eye behavior in Diabetic Macular Edema

Locations
Country Name City State
Pakistan Lions Medical Complex , Main Market, Gulberg ll Lahore Punjab

Sponsors (1)
Lead Sponsor Collaborator
Superior University

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Acuity Testing 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
Primary Optical Coherence Tomography 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
See also
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Terminated NCT04611152 - A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Terminated NCT04603937 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
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Completed NCT02221453 - Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide Phase 2
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Completed NCT00683176 - Effect of Choline Fenofibrate (SLV348) on Macular Edema Phase 2
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