Macular Edema, Retinal Vein Occlusion
Conditions
Keywords
Macular Edema, Retinal Vein Occlusion, Suprachoroidal Space, Triamcinolone Acetonide, RVO, ME
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.
Interventions
DRUGsuprachoroidal 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).
Sponsors
Damascus University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or nonpregnant female patients \>18 years of age. 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
1. 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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 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. |
Countries
Syria
Outcome results
None listed