Suprachoroidal Injection of Triamcinolone Acetonide for Management of Diabetic Macular Edema

NCT ID: NCT04069780

Last Updated: 2019-09-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-13
• Study Completion Date: 2021-08-07

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.

Detailed Description

The purposes of this study were:

1. To compare between intravitreal and suprachoroidalTA injection for treatment of DME in terms of improvement in both best corrected visual acuity (BCVA) and central macular thickness (CMT), and development of complications.

2. To identify which dose of TA will be efficient using the suprachoroidal route.

• Type of Study: A prospective interventional randomized comparative study.
• Study setting:Ophthalmology Department, Ain Shams University.
• Study period:2 years.
• Study population: Patients having DME.
• Sample size: The study will be conducted on 45 eyes. This was done using PASS program, setting alpha error at 5% and power at 80%. Results from previous study (Koc et al., 2017) showed that the mean improvement in BCVA after 6 months of intravitreal injection of TA was 4.6 ± 8.8. While it is assumed to be 12.6 and 14.6 for the low dose and high dose suprachoroidal route.
• Ethical considerations: Explanation of the procedure will be done for all patients and an informed written consent will be taken. Ethics committee approval will be obtained from the Institutional Review Board of the Faculty of Medicine, Ain Shams University.

All patients will undergo the following at initial presentation:

• Careful history taking.
• Full ophthalmological assessment including:

Baseline BCVA. Anterior segment examination using slit lamp biomicroscopy. IOP measurement using Goldmann applanation tonometer. Posterior segment examination using binocular indirect ophthalmoscopy and indirect slit lamp biomicroscopy (+90D Volk lens) for detailed evaluation of the macula and optic nerve head.

Fundus photography using VX-20 Kowa fundus camera, Japan. Ultrasound biomicroscopy (UBM) for measurement of scleral thickness in groups (II) and (III)using VuMax, Sonomed Escalon, theUnited States of America.

Spectral domain optical coherence tomography (SD-OCT) imaging using Retinascan RS 3000 advance, Nidek co.ltd, Gamgori, Japan.

Examination protocol: Macular map and 12 radial line scans to determine central macular thickness (1mm) and macular thickness in the inner 3 and 6 mm rings divided each into four quadrants.

Duration of follow up: 6 months.

Follow up schedule:

Follow up visits will be done at 1 day, 1 week, 1 month,3 months and 6 months.During the follow up, the following will be done:

• BCVA measurement.
• Full ophthalmological examination.
• Fundus photography after six months of injection.
• CMT measurement using SD-OCT at 1,3 and 6 months post-injection. In case of resistance to treatment (worsening of BCVA or CMT, or persistence of macular edema with central thickness less than 300µm), reinjection will be considered using the same drug and/or anti-VEGF agents.

Conditions

Safety; Efficacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group I : Intravitreal injection

A single intravitreal injection of 0.1 ml triamcinolone acetonide in a concentration of 4 mg / 0.1 ml.

Group Type: ACTIVE_COMPARATOR

Intravitreal injection (4mg/0.1ml)

Intervention Type: PROCEDURE

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.

Study group II: Suprachoroidal injection of full dose

A single suprachoroidal injection of 0.1 ml triamcinolone acetonide in a concentration of 4 mg / 0.1 ml.

Group Type: ACTIVE_COMPARATOR

Superachoroidal injection (4 mg/0.1ml)

Intervention Type: PROCEDURE

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.

Study group III : Suprachoroidal injection of half dose

They will receive a single suprachoroidal injection of 0.1 ml triamcinolone acetonide in a concentration of 2 mg / 0.1 ml.

Group Type: ACTIVE_COMPARATOR

Suprachoroidal injection (2mg/0.1ml)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: collaborator

Azza Mohamed Ahmed Said

OTHER

Sponsor Role: lead

Responsible Party

Azza Mohamed Ahmed Said

Professor of Ophthalmology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Abdelrahman G Salman, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Azza MA Said, MD

Role: CONTACT

dr_azza_22@hotmail.com

2001006228992

Yousra GZ Selim, Msc

Role: CONTACT

2001006799302

Other Identifiers

AinShamsU1

Identifier Type: -

Identifier Source: org_study_id