Suprachoroidal Injection of Triamcinolone- Review of a Novel Treatment for Macular Edema Caused by Noninfectious Uveitis.
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SUBMITTER: Price KW
PROVIDER: S-EPMC8315419 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionMacular edema due to noninfectious uveitis is a sight-threatening complication that is routinely treated with corticosteroids. Triamcinolone acetonide injectable suspension for suprachoroidal use (Xipere™) is an alternative treatment option for patients with non-infectious uveitis associated macular edema.Areas coveredThis review describes the recently FDA approved triamcinolone acetonide injectable suspension that can be injected into the suprachoroidal space. This physiological space is between the sclera and choroid. This allows for therapeutic targeting of the retina and choroid. This review highlights published clinical trials for this novel drug preparation.Expert opinionSuprachoroidal administration of triamcinolone acetonide has shown improvement in vision and inflammation in studies with non-infectious uveitis associated macular edema. This unique delivery method suggests the potential to decrease side effects of anterior segment exposure such as glaucoma and cataract, but head-to-head trials are needed for further study of safety and efficacy. Additionally, there are promising prospective studies underway for utilization of the suprachoroidal space for other diseases including macular degeneration, diabetic macular edema, and ocular tumors.
| S-EPMC9438525 | biostudies-literature
Project description:AimTo introduce a simple resistance controlled suprachoroidal space (SCS) injection technique using a disposable 30-gauge needle connected to a 1 mL syringe and evaluate the effectiveness and applicability of this technique in the treatment of macular edema.MethodsA total of 20 patients with various types of macular edema were subjected to a resistance controlled SCS injection of triamcinolone acetonide (TA) with a disposable 30-gauge needle connected to a 1 mL syringe. This technique allows the easy and smooth injection of the TA only once the tip of the needle reached the potential SCS which was indicated by the lower resistance on the plunger. The main outcome measures were anterior segment spectral-domain optical coherence tomography (AS-OCT) measurements post-operation immediately and central subfield thickness (CST), best-corrected visual acuity (BCVA), and intraocular pressure (IOP) measurements at 3mo post-operation.ResultsAS-OCT examination showed the expansion of the SCS near the injection site immediately after SCS injection. At three months of follow-up, as compared to the baseline, the mean CST was significantly decreased from 535.0±157.24 to 319.55±127.30 µm (P<0.001), the mean BCVA was significantly improved from 1.05±0.41 to 0.73±0.41 logMAR (P<0.001), and the mean IOP was not significantly different, from 15.05±2.54 to 15.85±3.60 mm Hg (P=0.185). Any complication related to the injection procedure including cataract, choroidal and retinal hemorrhage, retinal detachment, or endophthalmitis was not observed in this study.ConclusionThe simple and minimally invasive technique of SCS injection of TA with a disposable 30-gauge needle connected to a 1 mL syringe is useful and applicable for macular edema.
| S-EPMC9729086 | biostudies-literature
Project description:Triamcinolone acetonide injectable suspension for suprachoroidal use (Xipere®; SCS triamcinolone acetonide) is a corticosteroid approved in the USA for the treatment of macular edema associated with uveitis. Suprachoroidal injection of SCS triamcinolone acetonide results in preferential distribution into the posterior segment, which may reduce the risk of corticosteroid-related adverse events, such as cataracts and intraocular pressure (IOP) elevation. In a multicenter phase III trial in patients with non-infectious uveitic macular edema, SCS triamcinolone acetonide significantly and rapidly improved visual acuity and reduced signs of macular edema compared with sham treatment. SCS triamcinolone acetonide was generally well tolerated, with the most common adverse event being eye pain on the day of the procedure. The risk of corticosteroid-related IOP elevation appeared to be reduced in unrescued patients in the SCS triamcinolone acetonide group compared with patients in the sham control group who received rescue therapy. SCS triamcinolone acetonide is a novel and useful treatment option for uveitic macular edema.
| S-EPMC9512860 | biostudies-literature
Project description:PurposeThis article aims to compare between intravitreal (IV) and suprachoroidal (SC) triamcinolone acetonide (TA) injection for the treatment of diabetic macular edema (DME) in terms of improvement in both best-corrected visual acuity (BCVA) and central macular thickness (CMT), and development of complications (intraocular pressure (IOP) rise and cataract progression), and to identify the efficient dose of TA using the SC route.Patients and methodsThis prospective interventional randomized comparative study included 45 eyes of 32 patients, randomly divided into three groups, group I received 4 mg/0.1 mL intravitreal TA (IVTA), group II received 4 mg/0.1 mL suprachoroidal TA (SCTA), and group III received 2mg/0.1 mL SCTA. Patients were followed up for 6 months.ResultsAt 1 month, a maximum reduction in CMT (147.33 ± 110.97 µm, 160.80 ± 98.25 µm and 65.64 ± 46.19 µm in groups I, II, and III, respectively) was observed, which was associated with the greatest improvement of BCVA (0.09 ± 0.09, 0.19 ± 0.10 and 0.10 ± 0.09 logMAR lines) in groups I, II, and III, respectively. At 3 months, CMT started to increase, and reduction was not statistically significant compared to baseline, except in group II (4 mg SCTA group) (149.80 ± 106.57 µm with P-value = 0.013). At 6 months, CMT and BCVA returned close to baseline except for group II which had a sustained reduction of 60.16 µm from baseline. Regarding steroid-related complications, IOP elevation of 10 mmHg or more was noted in 1 eye (6.7%), 2 eyes (13.3%), and 1 eye in groups I, II, and III, respectively. Three phakic eyes per group showed cataract progression.ConclusionSCTA is a safe and effective route for the treatment of DME, which has comparable effects to IVTA, and may even last longer.
| S-EPMC8923681 | biostudies-literature
Project description:PurposeThe present study evaluated the effectiveness of suprachoroidal injection of triamcinolone acetonide (TA) in resistant diabetic macular edema (DME) using a modified microneedle.Patients and methodsThis is a prospective nonrandomized interventional study that was conducted on 55 eyes of 39 patients with centrally involving DME resistant to previous antivascular endotheli qal growth factor (VEGF) agents. All patients received suprachoroidal injection of triamcinolone acetonide 4 mg/0.1 mL by a modified specialized microneedle.ResultsThe mean central macular thickness (CMT) decreased sign ificantly from 478.7±170.2 µm before injection to 230.2±47.4 µm after 12 months with p-value <0.001. Significant improvement of the mean best corrected visual acuity (BCVA) from 1.193±0.2 by logMAR at the baseline to 0.76±0.3 by logMAR was achieved after 12 months with p-value <0.001. The IOP increased significantly at one month after injection and returned to the baseline value at the third month. Eyes with more baseline CMT and worse baseline BCVA achieved worse final BCVA 12 months after injection. Eyes with inner segment/outer segment (IS/OS) disruption and neurosensory detachment (NSD) showed worse final visual outcomes. IS/OS segment disruption, NSD and baseline BCVA were the main independent predictors of the final BCVA.ConclusionSuprachoroidal injection of TA using this new modified microneedle resulted in marked anatomical and functional results in cases of DME resistant to previous anti-VEGF drugs with no serious ocular or systemic side effects. The study was prospectively registered with clinical trial.gov ID (NCT04690608) in 27-12-2020.
| S-EPMC9698330 | biostudies-literature
Project description:PURPOSE:To evaluate choroidal and suprachoroidal changes following suprachoroidal injection of triamcinolone acetonide injectable suspension (CLS-TA), in eyes with macular edema due to retinal vein occlusion (RVO). DESIGN:Prospective cohort study within a randomized, controlled phase 2 clinical trial. METHODS:Enhanced depth imaging optical coherence tomography (EDI-OCT) images were analyzed from 38 eyes of 38 treatment-naïve patients with macular edema due to RVO, enrolled in the prospective Suprachoroidal Injection of Triamcinolone Acetonide with Intravitreal Aflibercept in Subjects with Macular Edema Due to Retinal Vein Occlusion (TANZANITE) study who received either a suprachoroidal injection of CLS-TA with an intravitreal injection of aflibercept (combination arm) or only an intravitreal injection of aflibercept (monotherapy arm), followed by monthly intravitreal aflibercept injections in both arms based on pro re nata criteria. RESULTS:Macular choroidal thickness measured to the outer choroidal vessel lumen (vascular choroidal thickness, VCT), outer choroid stroma (stromal choroidal thickness, SCT), or inner scleral border (total choroidal thickness, TCT) showed no significant changes over 3 months in both study arms (P = .231-.342). Eyes that received combination therapy showed a trend toward thickening of the suprachoroidal space (SCS) compared with monotherapy alone (13.4 μm vs 5.3 μm at 3 months; P = .077). In the 15 eyes that demonstrated a visible SCS at baseline, the SCS expanded significantly after suprachoroidal CLS-TA injection (16.2 μm to 27.8 μm at 3 months; P = .033). CONCLUSIONS:Suprachoroidal injection of CLS-TA does not alter choroidal thickness in eyes with macular edema due to RVO, but may result in expansion of the SCS.
| S-EPMC5805638 | biostudies-literature
Project description:Pseudophakic cystoid macular edema (PCME) is one of the leading causes of reduced vision, after cataract surgery. Topical steroids and nonsteroidal anti-inflammatory drops are frequently used in the management; however, intravitreal injections may be required for chronic cases. Suprachoroidal injection of preservative free Triamcinolone acetonide is a recent addition to the therapeutic armamentarium of ophthalmologists for treatment of cystoid macular edema of varied etiology. Though the drug is commercially available at a reasonable cost, the microneedle is not commonly available. We modified a 26 G needle for safe and cost-effective delivery of preservative-free suprachoroidal triamcinolone acetonide (SCT). In the current series of three patients with non-resolving PCME, macular edema resolved and vision improved over 3 months.
| S-EPMC7942133 | biostudies-literature
Project description:BackgroundSuprachoroidal Drug Delivery has emerged in recent years as a novel promising approach, which may help address the clinical unmet needs in the management of Retinal Vein Occlusion (RVO) associated Macular Edema (ME). In this study, we aim to evaluate the feasibility in regard of the potential efficacy and safety of suprachoroidal injection of Triamcinolone Acetonide (TA) using a microinjector as a mono-treatment of ME due to RVO.MethodsThis trial included 16 eyes of 16 patients with RVO associated ME presenting to the department of ophthalmology, Al Mouwasat university hospital, Syria. 4 mg of preserved TA was injected suprachoroidally 4 mm away from the inferotemporal limbus using a patient-customized microinjector. After injection, patients were followed after 1 week then monthly for 3 months. Primary outcome measures included the percentage of participants with best-corrected visual acuity (BCVA) gain≥15 letters and increased intraocular pressure (IOP) ≥ 20 mmHg in months 1,2, and 3, secondary measures included mean change from baseline BCVA, central subfield thickness (CST), and IOP through each of the follow-up points in addition to other measures.ResultsAfter injection, BCVA gain≥15 letters occurred in 68.7, 62.5, 50, 50% of patients at week 1 and through months 1,2 and 3 respectively, the mean BCVA improved significantly by 16.4, 16, 14.4, and 11.9 letters (p-value< 0.0005) at week 1 and months 1,2 and 3 respectively. This visual gain was associated with a significant reduction of CST by 290.94 ± 181.76 (week-1) (p-value< 0.0005), 274.31 ± 184.60 (month-1) (p-value< 0.0005), 183.50 ± 165.61 (month-2) (p-value = 0.006) and 137,75 ± 156.25 μm (month-3) (p-value = 0.038). We reported one case of increased IOP ≥ 20 mmHg in the first month that decreased in the second month. The mean change of IOP readings was not statistically significant, with an increase ranging from 0.75 mmHg after the first week (p-value = 0.09) and 0.5 mmHg after 3 months (p-value = 0.72).ConclusionThis study suggests that suprachoroidal TA could be well tolerated and efficacious as a mono-treatment of RVO associated ME. Future clinical trials are required to confirm its longer-term safety and efficacy and to compare this efficacy with the other therapeutic options.Trial registrationThis study was retrospectively registered at clinicaltrials.gov (ID: NCT05038072) on 08/09/2021. This article was published as a preprint on 22/06/2022. https://doi.org/10.21203/rs.3.rs-1701105/v1 .
| S-EPMC9921687 | biostudies-literature
Project description:Macular edema (ME) is a common cause of visual loss among eyes with uveitis, and its management can be challenging. Steroids are an effective treatment for ME, and intravitreal dexamethasone (DEX) implants provide sustained steroid release. The purpose of this study is to evaluate intravitreal DEX implant on refractory ME in eyes with noninfectious uveitis. A retrospective study including 52 eyes of 37 patients with refractory uveitic ME was conducted from January 2011 through August 2017 at Linkou Chang Gung Memorial Hospital in Taiwan. Patients' demographic characteristics were collected. In addition, clinical information, including corrected visual acuity (VA), intraocular pressure (IOP), and central retinal thickness (CRT) on optical coherence tomography, was recorded and analyzed. During the study period, affected eyes received a total of 110 intravitreal DEX implants (range, one to six in each eye). After the first DEX implant injection in all eyes, VA significantly improved at one and two months. CRT significantly decreased one month after a single DEX implant, and the effect lasted for six months and waned over time. Patients receiving multiple DEX implants still showed significant decreases in CRT one month after the first implant. Increases in IOP were noted one month after the DEX implant, but the IOP could be medically controlled. Intravitreal DEX implants can effectively treat refractory uveitic ME, improving both VA and CRT with an acceptable safety profile. Further studies are necessary to evaluate the effect of multiple implants and long-term outcomes.
| S-EPMC8432099 | biostudies-literature
Project description:PurposeTo evaluate the safety, tolerability, and preliminary efficacy of suprachoroidal injection of triamcinolone acetonide (TA) in patients with noninfectious uveitis.MethodsIn this Phase 1/2 open-label clinical study, a single suprachoroidal injection of 4-mg TA in 100 μL was performed in the study eye of patients with noninfectious intermediate, posterior, or pan-uveitis, and follow-up obtained for 26 weeks.ResultsNine individuals with chronic uveitis were enrolled. There were 38 reported adverse events (AEs); most were mild or moderate in severity. Approximately half the AEs were ocular. The most common AE was reported by four subjects who experienced ocular pain at or near the time of the injection. All systemic AEs were unrelated to study drug. No steroid-related increases in intraocular pressure (IOP) were observed and no subject required IOP-lowering medication. All eight efficacy-evaluable subjects had improvements in visual acuity. Four subjects, who did not need additional therapy, had on average a greater than 2-line improvement in visual acuity through week 26. Three of four had macular edema at baseline, and two of three had at least a 20% reduction in macular edema at week 26.ConclusionsThe safety and preliminary efficacy data support further investigations of suprachoroidally administered TA as a therapeutic option for the treatment of noninfectious uveitis.Translational relevanceTargeted suprachoroidal administration of corticosteroid is a potential local route for the treatment of ocular inflammatory disease, which merits further investigation. (www.ClinicalTrials.gov, NCT01789320).
| S-EPMC5156441 | biostudies-literature