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Suprachoroidal Injection of Triamcinolone Acetonide for Management of Diabetic Macular Edema

NCT04069780 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-09-03

No results posted yet for this study

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.

Conditions

  • Safety
  • Efficacy

Interventions

PROCEDURE

Intravitreal injection (4mg/0.1ml)

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.

PROCEDURE

Superachoroidal injection (4 mg/0.1ml)

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.

PROCEDURE

Suprachoroidal injection (2mg/0.1ml)

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.

Sponsors & Collaborators

  • Ain Shams University

    collaborator OTHER

  • Azza Mohamed Ahmed Said

    lead OTHER

Principal Investigators

  • Abdelrahman G Salman, MD · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-13
Primary Completion
2020-08-07
Completion
2021-08-07

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04069780 on ClinicalTrials.gov