Suprachoroidal Injection of Triamcinolone Acetonide for Management of Diabetic Macular Edema
SCI
Comparative Study Between Intravitreal and Suprachoroidal Injection of Triamcinolone Acetonide for Management of Diabetic Macular Edema
1 other identifier
interventional
45
1 country
1
Brief Summary
Intravitreal triamcinolone acetonide is a well-known method of treatment of diabetic macular edema, however, it has many side effects, most commonly causing cataract and glaucoma. Suprachoroidal route is an emerging route of delivery of intraocular drugs. This is to our knowledge the first prospective study to compare the effect of triamcinolone acetonide delivered via the intravitreal versus the suprachoroidal route in the treatment of diabetic macular edema as regards safety and efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
Typical duration for not_applicable
1 active site
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
March 13, 2019
CompletedFirst Submitted
Initial submission to the registry
August 23, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2021
CompletedSeptember 3, 2019
August 1, 2019
1.4 years
August 23, 2019
August 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Corrected Visual Acuity (BCVA)
Change in BCVA (Log.MAR) equal or more than 1 line
Six months after injection
Secondary Outcomes (2)
Central macular thickness (CMT)
Six months after injection
Complications
During the six months after injection
Study Arms (3)
Study group I : Intravitreal injection
ACTIVE COMPARATORA single intravitreal injection of 0.1 ml triamcinolone acetonide in a concentration of 4 mg / 0.1 ml.
Study group II: Suprachoroidal injection of full dose
ACTIVE COMPARATORA single suprachoroidal injection of 0.1 ml triamcinolone acetonide in a concentration of 4 mg / 0.1 ml.
Study group III : Suprachoroidal injection of half dose
ACTIVE COMPARATORThey will receive a single suprachoroidal injection of 0.1 ml triamcinolone acetonide in a concentration of 2 mg / 0.1 ml.
Interventions
Injection will be performed in the operating room under complete sterile conditions Under topical anaesthesia. Intravitreal injection (4mg/0.1ml) of triamicinolone acetonide will be done using a 30-31 gauge needle at a distance of 3.5 mm from the limbus in aphakic or pseudophakic patients, and 4 mm in phakic patients. The needle will be then removed with application of cotton tipped applicator over the entry site. -IOP monitoring will be done at 15, 30 and 60 minutes following injection in all groups.
Injection will be performed in the operating room under complete sterile conditions Under topical anaesthesia. Suprachoroidal injection (4mg/0.1ml) of triamcinolone acetonide will be done using a custom-made 30-31 gauge needle with a sleeve to prevent further penetration of the needle into the vitreous cavity. Injection will be done at approximately 4 mm from the limbus. * IOP monitoring will be done at 15, 30 and 60 minutes following injection in all groups. * UBM assessment will be done 24 hours following injection to confirm targeting of the suprachoroidal space.
njection will be performed in the operating room under complete sterile conditions Under topical anaesthesia. Suprachoroidal injection (2mg/0.1ml) of triamcinolone acetonide will be done using a custom-made 30-31 gauge needle with a sleeve to prevent further penetration of the needle into the vitreous cavity. Injection will be done at approximately 4 mm from the limbus. * IOP monitoring will be done at 15, 30 and 60 minutes following injection in all groups. * UBM assessment will be done 24 hours following injection to confirm targeting of the suprachoroidal space.
Eligibility Criteria
You may qualify if:
- Type-II Diabetes Mellitus patients.
- Centrally involving DME with central thickness\<300µm with no vitreomacular traction.
- Recently diagnosed DME or received treatment for DME in more than six months.
You may not qualify if:
- Pre-existingretinal disease other than diabetic retinopathy.
- Diabetic macular ischemia.
- IOP ≥ 21 mmHg and/or asymmetrical cup disc ratio or glaucoma patients.
- Prior cataract extraction of less than six months.
- Opaque media, uncooperative patients or patients with poor fixation.
- Any uncontrolled systemic disease.
- Systemic or local medicationsthat might affect the macular thickness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azza Mohamed Ahmed Saidlead
- Ain Shams Universitycollaborator
Study Sites (1)
Ain Shams University
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abdelrahman G Salman, MD
Ain Shams University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Ophthalmology
Study Record Dates
First Submitted
August 23, 2019
First Posted
August 28, 2019
Study Start
March 13, 2019
Primary Completion
August 7, 2020
Study Completion
August 7, 2021
Last Updated
September 3, 2019
Record last verified: 2019-08