Suprachoroidal Injection of Triamcinolone Acetonide in Resistant Diabetic Macular Edema, CRVO, Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema Following Pars Plana Vitrectomy (Resistant)

March 4, 2024 updated by: Amin El Sayed Nawar, Tanta University

Resistant Diabetic Macular Edema and Suprachoroidal Injection

Prospective interventional study on 60 eyes of resistant diabetic macular edema and central retinal vein occlusion that will receive suprachoroidal injection of Triamcinolone Acetonide (SCTA).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  • Prospective non randomized interventional study on 60 eyes of 40 patients with previously diagnosed macular edema secondary to type 1 or 2 diabetes mellitus and 60 eyes with central retinal vein occlusion will be included.
  • The study will be conducted from January 2021 to June 2021.
  • For transition to suprachoroidal injection of Triamcinolone Acetone (TAAC) a diagnosis of resistant DME is required.
  • Inclusion criteria:

Patients fulfilling one or more of the following criteria will be considered to have resistant diabetic macular edema (DME) after at least 3 consecutive monthly anti vascular endothelial growth factor (VEGF) injections in the previous 6 months: central macular thickness greater than 300 μm by spectral-domain optical coherence tomography (SD-OCT), reduction of retinal thickness by less than 10% of baseline retinal thickness, or suboptimal visual improvement (failure to gain at least 3 lines on the Snellen chart).

  • The subjects included in the research will undergo the following tests and investigations:

    1. Visual acuity testing (uncorrected and best corrected).
    2. Intra ocular pressure (IOP) by applanation tonometry.
    3. Anterior segment examination by slit lamp
    4. Posterior segment examination by indirect ophthalmoscope and 78 D lens
    5. Spectral domain Optical coherence tomography (OCT).
    6. Ocular fundus photography and fluorescein angiography.

  • Exclusion criteria will be:

    1. Previous intraocular surgery (except cataract surgery done more than 6 months before the study).
    2. Coincident retinal pathology as choroidal neovascular membrane and age related macular degeneration.
    3. Previous laser photocoagulation.
    4. Intravitreal injection of triamcinolone acetonide.
    5. Prior ocular inflammation.
    6. The presence of retinal degeneration.
    7. Patients who didnot complete 6 months of follow up

Injection technique:

Preoperative preparation:

  1. Preoperative control of (Diabetes Mellitus)DM is essential before injection.
  2. Informed consent was obtained according to the ethical committee after discussing extensively with each patient about the benefits, risks and possible side effects of the procedure .
  3. The patient was prepared by topical fluoroquinolone eye drops (Moxifloxacin hydrochloride 0.5% Vigamox ,Alcon, USA) 4 times daily for three days before injection.

All patients were dilated before suprachoroidal injection of Triamcinolone Acetonide (SCTA) and indirect ophthalmoscope was placed at hand to examine fundus after injection.

We used 30 gauge 1cc insulin syringe. Other dispensable included 24 gauge intravenous branula. Needle was withdrawn from branula and branula was cut in such a way that only 1000um of insulin syringe was exposed from the edge of branula. 0.1 ml (4 mg ) of Triamcinolone Acetonide (TAAC) will be injected.

Post operative care:

After the injection topical antibiotic drop was applied (Moxifloxacin hydrochloride 0.5% Vigamox, Alcon, USA) and the eye was patched for several hours.

After surgery patients were instructed to administer antibiotic drop four times daily for 3 days .

  • Privacy of the patients must be guaranteed ,the data acquired from the participants will stay confidential through:

    1. Putting a code number to every patient, with hiding the patient's name.
    2. Photographing faces will not be needed.
    3. The results of the research will be only used in scientific aim.
  • Any unexpected risks like subconjunctival hemorrhage, syncope, vitreous hemorrhage, retinal detachment and endophthalmitis appeared during the course of the research will be cleared to the participants and the ethical committee on time.

Medical care will be carried out to complications like syncope, subconjunctival hemorrhage and surgical treatment by pars plana vitrectomy will be done in case of occurrence of vitreous hemorrhage, retinal detachment or endophthalmitis.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • El Gharbia
      • Tanta, El Gharbia, Egypt, 31111
        • Tanta university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients fulfilling one or more of the following criteria will be considered to have resistant DME after at least 3 consecutive monthly anti VEGF injections in the previous 6 months:
  • Central macular thickness greater than 300 μm by spectral-domain optical coherence tomography (SD-OCT).
  • Reduction of retinal thickness by less than 10% of baseline retinal thickness.
  • Suboptimal visual improvement (failure to gain at least 3 lines on the Snellen chart) and patients with recent onset central retinal vein occlusion less than 3 months.

Exclusion Criteria:

  • Previous intraocular surgery (except cataract surgery done more than 6 months before the study).
  • Coincident retinal pathology as choroidal neovascular membrane and age related macular degeneration.
  • Previous laser photocoagulation.
  • Intravitreal injection of triamcinolone acetonide.
  • Prior ocular inflammation.
  • The presence of retinal degeneration.
  • Patients who didnot complete 6 months of follow up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: resistant diabetic macular edema and central retinal vein occlusion
  • Prospective non randomized interventional study on 60 eyes of 40 patients with previously diagnosed macular edema secondary to type 1 or 2 diabetes mellitus will be included.
  • The study will be conducted from January 2021 to June 2021.
  • For transition to suprachoroidal injection of TAAC a diagnosis of resistant DME is required.

Cases with recent onset central retinal vein occlusion less than 2 months duration will be included
Drug: Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1
suprachoroidal injection of the drug in cases of resistant diabetic macular edema and central retinal vein occlusion
Other Names:
  • 30 gauge syringe with 24 gauge cannula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of central macular thickness
Time Frame: 1 month
Reduction of the central macular thickness below 300 um
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improved vision
Time Frame: 3 months
Improvement of best corrected visual acuity
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Amin E Nawar, Lecturer, Faculty of medicine, Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

December 27, 2020

First Submitted That Met QC Criteria

December 29, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2412SS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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