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

Sponsor

Damascus University (Other)

Overall Status

Completed

CT.gov ID

NCT05038072

Collaborator

(none)

Enrollment

Location

Arm

19.2

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Macular Edema Retinal Vein Occlusion	Drug: suprachoroidal injection of Triamcinolone Acetonide.	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 25, 2019

Actual Primary Completion Date :

Nov 22, 2020

Actual Study Completion Date :

Feb 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 4 mg Triamcinolone Acetonide (TA)/ Suprachoriodal Injection Suprachoroidal injection of 4 mg in 100 μL of TA was administered as a single injection.	Drug: 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 Names: SCTA

Arm

Intervention/Treatment

Experimental: 4 mg Triamcinolone Acetonide (TA)/ Suprachoriodal Injection

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

Drug: 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 Names:

SCTA

Outcome Measures

Primary Outcome Measures

Percentage of participants with BCVA gain≥ 15 Letters at 3 months [3 months after injection]
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.
Percentage of participants with IOP ≥20 mm Hg at 3 months [3 months after injection]
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.

Secondary Outcome Measures

Change in the BCVA [1 week, 1 month, 2 months and 3 months after injection.]
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.
Change in the CST [1 week, 1 month, 2 months and 3 months after injection.]
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.
Change in the Proportion of Participants with CST ≤ 320 μ [1 week, 1 month, 2 months and 3 months after injection.]
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).
Change in the Percentage of Reduction in Excess Foveal Thickness (EFT) [1 week, 1 month, 2 months and 3 months after injection.]
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).
Change in the Serious Treatment-Emergent Adverse Events (S-TEAEs) [1 week, 1 month, 2 months and 3 months after injection.]
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.
Change in the IOP [1 week, 1 month, 2 months and 3 months after injection.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al Mouwasat University Hospital, Department of Ophthalmology	Damascus		Syrian Arab Republic

Sponsors and Collaborators

Damascus University

Investigators

Principal Investigator: Boushra M Ali, M.D., MRCSEd, Resident , Department of Ophthalmology, Faculty of Medicine, Damascus University
Study Chair: Arwa M Azmeh, Ph.D., Professor of Ophthalmology, Department of Ophthalmology, Faculty of Medicine, Damascus University