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Macular EdemaNCT05038072

The Use of Suprachoroidal Triamcinolone Acetonide to Treat Macular Edema in Retinal Vein Occlusion

A study testing suprachoroidal injection of Triamcinolone Acetonide. in people with Macular Edema and Retinal Vein Occlusion, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective non-randomized open-label interventional study aimed to evaluate feasibility in regard to potential efficacy and safety of triamcinolone acetonide (TA) injected in the suprachoroidal space (SCS) as a promising therapeutic route that provides a better bioavailability, longer sustained duration of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Macular Edema, Retinal Vein Occlusion
What is being tested?
suprachoroidal injection of Triamcinolone Acetonide.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteSyria
Study dates
25 Jul 2019to 28 Feb 2021
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or nonpregnant female patients >18 years of age.
  • Has a clinical diagnosis of Retinal Vein Occlusion (RVO) in the study eye.
  • Best-Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score ≥ 20 (20/400 Snellen equivalent), and ≤75 in the study eye (20/32 Snellen equivalent).
  • Central Subfield Thickness (CST) ≥310 microns measured by Spectral Domain Optical Coherence Tomography (SD-OCT) in the study eye.

Who cannot join

  • Intravitreal (IVT) injection of anti-VEGF: Bevacizumab (Avastin; Genentech, South San Francisco, CA, USA/Roche, Basel, Switzerland) or ranibizumab (Lucentis; Genentech Inc., South San Francisco, CA, USA) within 1 month and aflibercept (Eylea®; Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA, and Bayer HealthCare Pharmaceuticals, Berlin, Germany) within 2 months in the study eye.
  • Intraocular or periocular corticosteroid injection within 3 months, dexamethasone implant (Ozurdex, Allergan, Dublin, Ireland) within 6 months, Retisert (Bausch and Lomb, Bridge water, NJ) within 1 year, or fluocinolone acetonide implant (Iluvien, Alimera Sciences, Alpharetta, GA) within 3 years in the study eye.
  • Macular laser photocoagulation treatment in the study eye.
  • Topical ophthalmic nonsteroidal anti-inflammatory drugs in the study eye within a month.
  • Any significant media opacity that could hinder the evaluation of the retina or ocular condition causing decreased vision other than RVO.
  • IOP >22 mm Hg, or history of steroid-induced ocular hypertension; uncontrolled glaucoma.
  • Past vitreoretinal or glaucoma surgery in the study eye.
  • Uncontrolled systemic disease that could hinder follow-up, immunodeficiency, or any other systemic contraindication for steroids.

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • Al Mouwasat University Hospital, Department of Ophthalmology

    Damascus

Other trials in Syria

About this study

Official title: Suprachoroidal Triamcinolone Acetonide for the Treatment of Macular Edema Associated With Retinal Vein Occlusion: A Pilot Study

This prospective non-randomized open-label interventional study aimed to evaluate feasibility in regard to potential efficacy and safety of triamcinolone acetonide (TA) injected in the suprachoroidal space (SCS) as a promising therapeutic route that provides a better bioavailability, longer sustained duration of action, and thus improved patients' compliance for the treatment of macular edema due to retinal vein occlusion (RVO).

Read the detailed description

Management of Macular Edema (ME) associated with Retinal Vein Occlusion (RVO) still poses a therapeutic challenge taking into account its complicated etiopathogenesis. Despite improved visual and anatomical outcomes achieved by intravitreal injections of antiangiogenics and steroids, these treatments are still associated with non-responders, tachyphylaxis, rebound phenomenon, high re-injection, and adverse events rates, which underscore the importance of addressing new approaches to formulate treatment strategies.

Delivery of therapeutic agents into the suprachoroidal space (SCS) provides a novel alternative approach that has theoretical appeal, as it dominantly targets chorioretinal tissues with the posterior and circumferential spread of the drug administered while relatively sparing the unaffected anterior segment of the eye and the vitreous chamber, thus minimizing risks associated with off-target effects, which potentiates safety. This was well translated in preclinical and clinical studies through microinjector, which has been shown to provide a safe, minimally invasive, and reliable method of targeting SCS. In addition, sustained duration and favorable pharmacokinetics have been observed for small molecule suspensions including Triamcinolone Acetonide (TA), with the potential to reduce treatment burden.

Being tested
suprachoroidal injection of Triamcinolone Acetonide.
Keywords
Macular Edema, Retinal Vein Occlusion, Suprachoroidal Space, Triamcinolone Acetonide, RVO, ME
Medical subject headings
Macular Edema, Retinal Vein Occlusion, Choroidal Effusions

What participants receive

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

  • suprachoroidal injection of Triamcinolone Acetonide.Drug

    Also called SCTA

    4 mg /0.1 ml TA was injected in the SCS using an individualized microinjector according to scleral thickness measured by anterior segment OCT (AS-OCT) at the injection point (4 mm from the limbus in the inferotemporal quadrant).

Study groups in NCT05038072
Study groupRoleWhat they receive
4 mg Triamcinolone Acetonide (TA)/ Suprachoriodal InjectionExperimentalSuprachoroidal injection of 4 mg in 100 μL of TA was administered as a single injection.
Receives: Drug: suprachoroidal injection of Triamcinolone Acetonide.

What is being measured

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

  1. Percentage of participants with BCVA gain≥ 15 Letters at 3 months

    Percentage of participants with ≥ 15 letter Improvement from Baseline Best corrected visual acuity (BCVA) using Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity score: BCVA refers to the measurement of the best possible vision that can be achieved following refraction. BCVA was assessed using a Snellen chart. The resultant measures were converted to Early Treatment of Diabetic Retinopathy Study ETDRS letter score. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.

    Measured: 3 months after injection

  2. Percentage of participants with IOP ≥20 mm Hg at 3 months

    Intraocular pressure (IOP) is the fluid pressure inside the eye. Tonometry is the method that eye care professionals use to determine this. Tonometers in this study were calibrated to measure pressure in millimeters of mercury.

    Measured: 3 months after injection

Secondary outcomes (6)

  1. Change in the BCVA

    Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction. BCVA was assessed using a Snellen chart. The resultant measures were converted to ETDRS letter score. A positive change from baseline value represents an improvement in vision.

    Measured: 1 week, 1 month, 2 months and 3 months after injection.

  2. Change in the CST

    Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT) (Heidelberg Spectralis; Heidelberg Engineering, Germany). A negative change from baseline value represents a reduction in macular edema.

    Measured: 1 week, 1 month, 2 months and 3 months after injection.

  3. Change in the Proportion of Participants with CST ≤ 320 μ

    Central subfield thickness (CST) is the average macular thickness in the central circular area 1 mm in diameter centered around the fovea and is a diagnostic measurement applied to diagnose macular edema. CST was measured using spectral domain optical coherence tomography (SD-OCT) (Heidelberg Spectralis; Heidelberg Engineering, Germany).

    Measured: 1 week, 1 month, 2 months and 3 months after injection.

  4. Change in the Percentage of Reduction in Excess Foveal Thickness (EFT)

    Excess Foveal Thickness (EFT) was estimated by subtracting 310 µ from the central subfield thickness (CST). CST was measured using spectral domain optical coherence tomography (SD-OCT) (Heidelberg Spectralis; Heidelberg Engineering, Germany).

    Measured: 1 week, 1 month, 2 months and 3 months after injection.

  5. Change in the Serious Treatment-Emergent Adverse Events (S-TEAEs)

    Number of patients with Serious Treatment-Emergent Adverse Events (S-TEAEs): A treatment-emergent adverse event (TEAE) is the development of an undesirable medical condition or the worsening of a preexisting medical condition either in intensity or frequency after exposure to a pharmaceutical product. Ophthalmic Serious TEAEs include Endophthalmitis, intraocular inflammation, vitreal hemorrhage, retinal tear and Rhegmatogenous retinal detachment.

    These Adverse Events were evaluated through anterior and posterior segments examination using slit lamp biomicroscopy and indirect ophthalmoscopy.

    Measured: 1 week, 1 month, 2 months and 3 months after injection.

  6. Change in the IOP

    Intraocular pressure (IOP) is the fluid pressure inside the eye. Tonometry is the method that eye care professionals use to determine this. Tonometers in this study were calibrated to measure pressure in millimeters of mercury.

    Measured: 1 week, 1 month, 2 months and 3 months after injection.

Timeline

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

  1. First posted8 Sep 2021
  2. Study start25 Jul 2019
  3. Primary completion22 Nov 2020
  4. Study completion28 Feb 2021

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
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05038072
Sponsor's protocol ID
UDMS-Opthal-01-2021
Status last verified
Aug 2021
First submitted
24 Aug 2021
Last updated
8 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Campochiaro PA, Sophie R, Pearlman J, Brown DM, Boyer DS, Heier JS, Marcus DM, Feiner L, Patel A; RETAIN Study Group. Long-term outcomes in patients with retinal vein occlusion treated with ranibizumab: the RETAIN study. Ophthalmology. 2014 Jan;121(1):209-219. doi: 10.1016/j.ophtha.2013.08.038. Epub 2013 Oct 7.

    PubMed 24112944

  • Spooner K, Fraser-Bell S, Hong T, Chang AA. Five-year outcomes of retinal vein occlusion treated with vascular endothelial growth factor inhibitors. BMJ Open Ophthalmol. 2019 Mar 29;4(1):e000249. doi: 10.1136/bmjophth-2018-000249. eCollection 2019.

    PubMed 30997407

  • Ciulla T, Pollack JS, Williams DF. Visual acuity outcomes and anti-VEGF therapy intensity in macular oedema due to retinal vein occlusion: a real-world analysis of 15 613 patient eyes. Br J Ophthalmol. 2021 Dec;105(12):1696-1704. doi: 10.1136/bjophthalmol-2020-317337. Epub 2020 Oct 14.

    PubMed 33055088

  • Moisseiev E, Loewenstein A, Yiu G. The suprachoroidal space: from potential space to a space with potential. Clin Ophthalmol. 2016 Jan 25;10:173-8. doi: 10.2147/OPTH.S89784. eCollection 2016.

    PubMed 26869750

  • Hancock SE, Wan CR, Fisher NE, Andino RV, Ciulla TA. Biomechanics of suprachoroidal drug delivery: From benchtop to clinical investigation in ocular therapies. Expert Opin Drug Deliv. 2021 Jun;18(6):777-788. doi: 10.1080/17425247.2021.1867532. Epub 2021 Jan 3.

    PubMed 33393391

  • Wan CR, Muya L, Kansara V, Ciulla TA. Suprachoroidal Delivery of Small Molecules, Nanoparticles, Gene and Cell Therapies for Ocular Diseases. Pharmaceutics. 2021 Feb 22;13(2):288. doi: 10.3390/pharmaceutics13020288.

    PubMed 33671815

  • Habot-Wilner Z, Noronha G, Wykoff CC. Suprachoroidally injected pharmacological agents for the treatment of chorio-retinal diseases: a targeted approach. Acta Ophthalmol. 2019 Aug;97(5):460-472. doi: 10.1111/aos.14042. Epub 2019 Jan 31.

    PubMed 30702218

  • Chiang B, Jung JH, Prausnitz MR. The suprachoroidal space as a route of administration to the posterior segment of the eye. Adv Drug Deliv Rev. 2018 Feb 15;126:58-66. doi: 10.1016/j.addr.2018.03.001. Epub 2018 Mar 12.

    PubMed 29545195

  • Campochiaro PA, Wykoff CC, Brown DM, Boyer DS, Barakat M, Taraborelli D, Noronha G; Tanzanite Study Group. Suprachoroidal Triamcinolone Acetonide for Retinal Vein Occlusion: Results of the Tanzanite Study. Ophthalmol Retina. 2018 Apr;2(4):320-328. doi: 10.1016/j.oret.2017.07.013. Epub 2017 Sep 29.

    PubMed 31047241

  • Wan CR, Kapik B, Wykoff CC, Henry CR, Barakat MR, Shah M, Andino RV, Ciulla TA. Clinical Characterization of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders. Transl Vis Sci Technol. 2020 Oct 22;9(11):27. doi: 10.1167/tvst.9.11.27. eCollection 2020 Oct.

    PubMed 33150052

  • Ali BM, Azmeh AM, Alhalabi NM. Suprachoroidal triamcinolone acetonide for the treatment of macular edema associated with retinal vein occlusion: a pilot study. BMC Ophthalmol. 2023 Feb 10;23(1):60. doi: 10.1186/s12886-023-02808-5.

    PubMed 36765332

Questions about this trial

What is this clinical trial studying?

A study testing suprachoroidal injection of Triamcinolone Acetonide. in people with Macular Edema and Retinal Vein Occlusion, run by Damascus University at 1 site in Syria.

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 8 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: finished, as of the sponsor's last update on 8 Sep 2021. 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 Syria. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with BCVA gain≥ 15 Letters at 3 months (time frame: 3 months after injection). The study lists 2 primary outcomes in all. 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 NCT05038072, which also lists 11 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 8 Sep 2021.

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