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

Primary Purpose

Macular Edema, Retinal Vein Occlusion

Status

Completed

Phase

Not Applicable

Locations

Syrian Arab Republic

Study Type

Interventional

Intervention

suprachoroidal injection of Triamcinolone Acetonide.

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring Macular Edema, Retinal Vein Occlusion, Suprachoroidal Space, Triamcinolone Acetonide, RVO, ME

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Al Mouwasat University Hospital, Department of Ophthalmology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

4 mg Triamcinolone Acetonide (TA)/ Suprachoriodal Injection

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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).

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).

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.

Change in the IOP

Full Information

NCT ID

NCT05038072

First Posted

August 24, 2021

Last Updated

August 31, 2021

Sponsor

Damascus University

1. Study Identification

Unique Protocol Identification Number

NCT05038072

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

July 25, 2019 (Actual)

Primary Completion Date

November 22, 2020 (Actual)

Study Completion Date

February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Edema, Retinal Vein Occlusion

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

4 mg Triamcinolone Acetonide (TA)/ Suprachoriodal Injection

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

suprachoroidal injection of Triamcinolone Acetonide.

Other Intervention Name(s)

SCTA

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Description

Time Frame

3 months after injection

Title

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

Description

Time Frame

3 months after injection

Secondary Outcome Measure Information:

Title

Change in the BCVA

Description

Time Frame