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AzTrials

Retinal EdemaEarly Phase 1ResistantNCT04690608

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

A Early Phase 1 study testing Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1 in people with Retinal Edema, run by Tanta University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Retinal Edema
What is being tested?
Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Dec 2024to 1 Feb 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Amin E Nawar, Lecturer contact

00201140095692

nawar20012002@gmail.com

Esraa A Mohammad, L;ecturer contact

00201201500472

esraaaziz87@gmail.com

Egypt1 site
  • Tanta University

    Tanta, El Gharbia, 31111

Other trials in Egypt

About this study

Official title: 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).

Read the 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.

Conditions
Retinal Edema
Being tested
Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1
Keywords
macular edema
Medical subject headings
Papilledema, Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1Drug

    Also called 30 gauge syringe with 24 gauge cannula

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

Study groups in NCT04690608
Study groupRoleWhat they receive
resistant diabetic macular edema and central retinal vein occlusionExperimental* 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
Receives: Drug: Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement of central macular thickness

    Reduction of the central macular thickness below 300 um

    Measured: 1 month

Secondary outcomes (1)
  1. improved vision

    Improvement of best corrected visual acuity

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2020
  2. Study start1 Dec 2024 (estimated)
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
cases of resistant diabetic macular edema and central retinal vein occlusion
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04690608
Sponsor's protocol ID
2412SS
Acronym
Resistant
Status last verified
Mar 2024
First submitted
27 Dec 2020
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40604486
  • 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.

    PubMed 36438589
  • 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.

    PubMed 35469288

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1 in people with Retinal Edema, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Amin E Nawar, Lecturer (00201140095692, nawar20012002@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement of central macular thickness (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04690608, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.

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