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

NCT05038072 | Completed

• 1 other identifier: UDMS-Opthal-01-2021
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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 action, and thus improved patients' compliance for the treatment of macular edema due to retinal vein occlusion (RVO).

Conditions

Macular Edema; Retinal Vein Occlusion

Keywords

Macular Edema; Retinal Vein Occlusion; Suprachoroidal Space; Triamcinolone Acetonide; RVO; ME

Outcome Measures

Primary Outcomes (2)

• 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.

  3 months after injection

• 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.

  3 months after injection

Secondary Outcomes (6)

• Change in the BCVA

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

• Change in the CST

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

• Change in the Proportion of Participants with CST ≤ 320 μ

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

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

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

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

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

Study Arms (1)

4 mg Triamcinolone Acetonide (TA)/ Suprachoriodal Injection

EXPERIMENTAL

Suprachoroidal injection of 4 mg in 100 μL of TA was administered as a single injection.

Drug: suprachoroidal injection of Triamcinolone Acetonide.

Interventions

suprachoroidal injection of Triamcinolone Acetonide. DRUG

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).

Also known as: SCTA

4 mg Triamcinolone Acetonide (TA)/ Suprachoriodal Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Al Mouwasat University Hospital, Department of Ophthalmology

Damascus, Syria

Location

Related Publications (11)

• 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.

  PMID: 24112944 BACKGROUND

• 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.

  PMID: 30997407 BACKGROUND

• 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.

  PMID: 33055088 BACKGROUND

• 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.

  PMID: 26869750 BACKGROUND

• 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.

  PMID: 33393391 BACKGROUND

• 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.

  PMID: 33671815 BACKGROUND

• 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.

  PMID: 30702218 BACKGROUND

• 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.

  PMID: 29545195 BACKGROUND

• 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.

  PMID: 31047241 BACKGROUND

• 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.

  PMID: 33150052 BACKGROUND

• 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.

  PMID: 36765332 DERIVED

MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion; Choroidal Effusions

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Eye Abnormalities; Choroid Diseases; Uveal Diseases

Study Officials

• Boushra M Ali, M.D., MRCSEd

  Resident , Department of Ophthalmology, Faculty of Medicine, Damascus University

  PRINCIPAL INVESTIGATOR

• Arwa M Azmeh, Ph.D.

  Professor of Ophthalmology, Department of Ophthalmology, Faculty of Medicine, Damascus University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 8, 2021
• Study Start: July 25, 2019
• Primary Completion: November 22, 2020
• Study Completion: February 28, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-08

Locations

SY (1)