The Use of Suprachoroidal Triamcinolone Acetonide to Treat Macular Edema in Retinal Vein Occlusion
NCT ID: NCT05038072
Last Updated: 2021-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2019-07-25
2021-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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4 mg Triamcinolone Acetonide (TA)/ Suprachoriodal Injection
Suprachoroidal injection of 4 mg in 100 μL of TA was administered as a single injection.
suprachoroidal injection of Triamcinolone Acetonide.
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).
Interventions
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suprachoroidal injection of Triamcinolone Acetonide.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has a clinical diagnosis of Retinal Vein Occlusion (RVO) in the study eye.
3. 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).
4. Central Subfield Thickness (CST) ≥310 microns measured by Spectral Domain Optical Coherence Tomography (SD-OCT) in the study eye.
Exclusion Criteria
2. 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.
3. Macular laser photocoagulation treatment in the study eye.
4. Topical ophthalmic nonsteroidal anti-inflammatory drugs in the study eye within a month.
5. Any significant media opacity that could hinder the evaluation of the retina or ocular condition causing decreased vision other than RVO.
6. IOP \>22 mm Hg, or history of steroid-induced ocular hypertension; uncontrolled glaucoma.
7. Past vitreoretinal or glaucoma surgery in the study eye.
8. Uncontrolled systemic disease that could hinder follow-up, immunodeficiency, or any other systemic contraindication for steroids.
18 Years
ALL
No
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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Boushra M Ali, M.D., MRCSEd
Role: PRINCIPAL_INVESTIGATOR
Resident , Department of Ophthalmology, Faculty of Medicine, Damascus University
Arwa M Azmeh, Ph.D.
Role: STUDY_CHAIR
Professor of Ophthalmology, Department of Ophthalmology, Faculty of Medicine, Damascus University
Locations
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Al Mouwasat University Hospital, Department of Ophthalmology
Damascus, , Syria
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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UDMS-Opthal-01-2021
Identifier Type: -
Identifier Source: org_study_id
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