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

NCT04690608 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 2412SS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Retinal Edema

Keywords

macular edema

Outcome Measures

Primary Outcomes (1)

• Improvement of central macular thickness

  Reduction of the central macular thickness below 300 um

  1 month

Secondary Outcomes (1)

• improved vision

  3 months

Study Arms (1)

resistant diabetic macular edema and central retinal vein occlusion

EXPERIMENTAL

* 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

Interventions

Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1 DRUG

suprachoroidal injection of the drug in cases of resistant diabetic macular edema and central retinal vein occlusion

Also known as: 30 gauge syringe with 24 gauge cannula

resistant diabetic macular edema and central retinal vein occlusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El Gharbia, 31111, Egypt

Location

Related Publications (3)

• Nawar AE. Efficacy of combined topical nepafenac 0.3% with suprachoroidal injection of triamcinolone acetonide using a modified custom needle in pseudopkakic cystoid macular edema. BMC Ophthalmol. 2025 Jul 3;25(1):350. doi: 10.1186/s12886-025-03972-6.

  PMID: 40604486 DERIVED

• Nawar AE. Effectiveness of Suprachoroidal Injection of Triamcinolone Acetonide in Resistant Diabetic Macular Edema Using a Modified Microneedle. Clin Ophthalmol. 2022 Nov 21;16:3821-3831. doi: 10.2147/OPTH.S391319. eCollection 2022.

  PMID: 36438589 DERIVED

• 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.

  PMID: 35469288 DERIVED

MeSH Terms

Conditions

Papilledema; Macular Edema

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Amin E Nawar, Lecturer

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amin E Nawar, Lecturer

CONTACT

00201140095692; nawar20012002@gmail.com

Esraa A Mohammad, L;ecturer

CONTACT

00201201500472; esraaaziz87@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: code number will be given for each participant
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Of Ophthalmology, Tanta university

Model Details: cases of resistant diabetic macular edema and central retinal vein occlusion

Study Record Dates

• First Submitted: December 27, 2020
• First Posted: December 30, 2020
• Study Start: December 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)