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Suprachoroidal Injection of Triamcinolone Acetonide in Resistant Diabetic Macular Edema and CRVO (Resistant)

Primary Purpose

Retinal Edema

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Edema focused on measuring macular edema

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tanta University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

resistant diabetic macular edema and central retinal vein occlusion

Arm 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 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

Outcomes

Primary Outcome Measures

Improvement of central macular thickness
Reduction of the central macular thickness below 300 um

Secondary Outcome Measures

improved vision
Improvement of best corrected visual acuity

Full Information

First Posted
December 27, 2020
Last Updated
April 10, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04690608
Brief Title
Suprachoroidal Injection of Triamcinolone Acetonide in Resistant Diabetic Macular Edema and CRVO
Acronym
Resistant
Official Title
Resistant Diabetic Macular Edema and Suprachoroidal Injection
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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: Visual acuity testing (uncorrected and best corrected). Intra ocular pressure (IOP) by applanation tonometry. Anterior segment examination by slit lamp Posterior segment examination by indirect ophthalmoscope and 78 D lens Spectral domain Optical coherence tomography (OCT). Ocular fundus photography and fluorescein angiography. Exclusion criteria will be: 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 Injection technique: Preoperative preparation: Preoperative control of (Diabetes Mellitus)DM is essential before injection. 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 . 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: Putting a code number to every patient, with hiding the patient's name. Photographing faces will not be needed. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Edema
Keywords
macular edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
cases of resistant diabetic macular edema and central retinal vein occlusion
Masking
None (Open Label)
Masking Description
code number will be given for each participant
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
resistant diabetic macular edema and central retinal vein occlusion
Arm Type
Experimental
Arm 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 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
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1
Other Intervention Name(s)
30 gauge syringe with 24 gauge cannula
Intervention Description
suprachoroidal injection of the drug in cases of resistant diabetic macular edema and central retinal vein occlusion
Primary Outcome Measure Information:
Title
Improvement of central macular thickness
Description
Reduction of the central macular thickness below 300 um
Time Frame
1 month
Secondary Outcome Measure Information:
Title
improved vision
Description
Improvement of best corrected visual acuity
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amin E Nawar, Lecturer
Phone
00201140095692
Email
nawar20012002@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Esraa A Mohammad, L;ecturer
Phone
00201201500472
Email
esraaaziz87@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amin E Nawar, Lecturer
Organizational Affiliation
Faculty of medicine, Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El Gharbia
ZIP/Postal Code
31111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35469288
Citation
Nawar AE. Modified Microneedle for Suprachoroidal Injection of Triamcinolone Acetonide Combined with Intravitreal Injection of Ranibizumab in Branch Retinal Vein Occlusion Patients. Clin Ophthalmol. 2022 Apr 19;16:1139-1151. doi: 10.2147/OPTH.S361636. eCollection 2022.
Results Reference
derived

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Suprachoroidal Injection of Triamcinolone Acetonide in Resistant Diabetic Macular Edema and CRVO

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