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Suprachoroidal Injection of Triamcinolone Acetonide for Management of Diabetic Macular Edema (SCI)

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ClinicalTrials.gov Identifier: NCT04069780
Recruitment Status : Recruiting
First Posted : August 27, 2019
Last Update Posted : September 2, 2019
Sponsor:
Collaborator:
Ain Shams University
Information provided by (Responsible Party):
Azza Mohamed Ahmed Said, Ain Shams University

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.


Condition or disease Intervention/treatment Phase
Safety Efficacy Procedure: Intravitreal injection (4mg/0.1ml) Procedure: Superachoroidal injection (4 mg/0.1ml) Procedure: Suprachoroidal injection (2mg/0.1ml) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study Between Intravitreal and Suprachoroidal Injection of Triamcinolone Acetonide for Management of Diabetic Macular Edema
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : August 7, 2020
Estimated Study Completion Date : August 7, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Study group I : Intravitreal injection
A single intravitreal injection of 0.1 ml triamcinolone acetonide in a concentration of 4 mg / 0.1 ml.
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.


Active Comparator: 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.
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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Best Corrected Visual Acuity (BCVA) [ Time Frame: Six months after injection ]
    Change in BCVA (Log.MAR) equal or more than 1 line


Secondary Outcome Measures :
  1. Central macular thickness (CMT) [ Time Frame: Six months after injection ]
    Change in CMT (um) equal or more than 50 um

  2. Complications [ Time Frame: During the six months after injection ]
    e.g. change in intraocular pressure



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069780


Contacts
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Contact: Azza MA Said, MD 2001006228992 dr_azza_22@hotmail.com
Contact: Yousra GZ Selim, Msc 2001006799302

Locations
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Egypt
Ain Shams University Recruiting
Cairo, Egypt
Sponsors and Collaborators
Azza Mohamed Ahmed Said
Ain Shams University
Investigators
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Principal Investigator: Abdelrahman G Salman, MD Ain Shams University

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Responsible Party: Azza Mohamed Ahmed Said, Professor of Ophthalmology, Ain Shams University
ClinicalTrials.gov Identifier: NCT04069780     History of Changes
Other Study ID Numbers: AinShamsU1
First Posted: August 27, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Azza Mohamed Ahmed Said, Ain Shams University:
Suprachoroidal injection
Diabetic macular edema
Tiamicinolone acetonide
Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action