-
1.
Prospective randomised clinical trial of intravitreal bevacizumab versus triamcinolone in eyes with diabetic macular oedema undergoing cataract surgery: 6-month results.
Kandasamy, R, Constantinou, M, Rogers, SL, Sandhu, SS, Wickremasinghe, S, Al-Qureshi, S, Lim, LL
The British journal of ophthalmology. 2019;(12):1753-1758
Abstract
AIM: To report the 6-month results of a clinical trial that compared intravitreous bevacizumab (BVB) 1.25 mg versus triamcinolone acetonide (TA) 4 mg when administered as an adjunct during cataract surgery to patients with diabetic macular oedema (DMO). METHODS Prospective, double-masked, single-centre (Royal Victorian Eye and Ear Hospital, Melbourne) clinical trial. Patients with visually significant cataract and centre-involving DMO (either current or prior) were randomised (1: 1) to receive either intravitreous BVB 1.25 mg or TA 4 mg at the time of cataract surgery and if required at review. Main outcome measures were changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to the 6-month time point of this 12-month study. RESULTS 61 eyes of 58 patients were enrolled. At baseline, both groups were similar in terms of BCVA and CMT (p>0.2). At 6 months, there was no significant difference in vision between the groups, with mean letter gain of +21.4 (95% CI +14.5 to +28.4) in the TA group and +17.3 (95% CI +12.1 to +22.6) in the BVB group (p=0.35). The TA group had a significant sustained anatomical improvement at 6 months, with a reduction in CMT (-51.4 µm; 95% CI -98.2 to -4.7) compared with thickening in the BVB group (+15.6 µm; 95% CI -26.4 to +57.7, p=0.04). CONCLUSIONS When given as an adjunct to cataract surgery, both TA and BVB improved visual outcomes at 6 months postoperatively. However, only TA resulted in sustained improvement in CMT, with the majority not requiring any further treatment postoperatively.
-
2.
SUPRACHOROIDAL INJECTION OF TRIAMCINOLONE ACETONIDE, CLS-TA, FOR MACULAR EDEMA DUE TO NONINFECTIOUS UVEITIS: A Randomized, Phase 2 Study (DOGWOOD).
Yeh, S, Kurup, SK, Wang, RC, Foster, CS, Noronha, G, Nguyen, QD, Do, DV, ,
Retina (Philadelphia, Pa.). 2019;(10):1880-1888
Abstract
PURPOSE Evaluate a single suprachoroidal injection of a proprietary triamcinolone acetonide suspension, CLS-TA, in subjects with macular edema due to noninfectious uveitis. METHODS Randomized, controlled, masked Phase 2 study. Safety and efficacy of a single suprachoroidal injection of CLS-TA (4.0 and 0.8 mg in a 4:1 ratio) were assessed at 1 and 2 months after injection. The primary efficacy endpoint was change in central subfield thickness from baseline to Month 2, assessed by spectral domain optical coherence tomography. RESULTS Twenty-two adults were enrolled. The primary endpoint was met in subjects who received suprachoroidal injection of CLS-TA 4.0 mg, mean central subfield thickness significantly decreased from baseline by 135 µm and 164 µm at Month 1 (P = 0.0056) and Month 2 (P = 0.0017), respectively. At Month 2, 69% of subjects who received 4.0 mg experienced ≥20% reduction in central subfield thickness, and 65% had improvement of best-corrected visual acuity of ≥5 Early Treatment Diabetic Retinopathy Study letters, with a mean improvement of 9.2 letters (P = 0.0004). Safety analyses supported acceptable safety/tolerability, with no corticosteroid-related increases in intraocular pressure. CONCLUSION A single suprachoroidal injection of CLS-TA (4.0 mg; 0.1 mL) in subjects with macular edema due to noninfectious uveitis was well-tolerated, significantly reduced central subfield thickness from baseline at 2 months, and significantly improved visual acuity.
-
3.
Phase II/III Clinical Trial of Sub-Tenon Injection of Triamcinolone Acetonide (WP-0508ST) for Diabetic Macular Edema.
Ogura, Y, Shimura, M, Iida, T, Sakamoto, T, Yoshimura, N, Yamada, M, Ishibashi, T
Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde. 2019;(3):161-169
Abstract
PURPOSE To assess the efficacy and safety of sub-Tenon injection of triamcinolone acetonide (WP-0508ST) for the patients with diabetic macular edema (DME). METHODS This multicenter, randomized, double-masked, comparative, controlled study was performed in 95 patients with DME. The patients were randomly divided into 20 mg WP-0508ST, 40 mg WP-0508ST, and control groups. RESULTS A significant improvement in central macular thickness (CMT) was observed (p < 0.001) at 12 weeks after a single sub-Tenon injection of 20 mg WP-0508ST. The 40 mg group also demonstrated improvement in CMT, but the difference was not significant. In addition, the best-corrected visual acuity was improved in both the 20 mg and 40 mg groups at 12 weeks. The major side effects were increased intraocular pressure (9.4% in the 20 mg group and 13.3% in the 40 mg group) and lenticular opacity (6.3% in the 20 mg group and 10.0% in the 40 mg group). However, none of the patients with increased intraocular pressure required surgery. CONCLUSION The efficacy and tolerability of WP-0508ST in the treatment of DME were confirmed, and 20 mg was determined to be the optimal dose.
-
4.
Effect of intravitreal or sub-tenon triamcinolone acetonide injection at completion of vitrectomy on peripheral retinochoroidal thickness in eyes with proliferative diabetic retinopathy.
Fujiwara, Y, Iwase, T, Yamamoto, K, Ueno, Y, Ra, E, Terasaki, H
Scientific reports. 2019;(1):171
Abstract
The effect of triamcinolone acetonide (TA) on the peripheral retinochoroidal thickness was determined after pars plana vitrectomy (PPV) with scatter photocoagulation in eyes with proliferative diabetic retinopathy. The peripheral retinochoroidal thickness was measured at 5 mm from the limbus in the four quadrants using anterior segment optical coherence tomography before, and 3 days, and 1 and 2 weeks after the surgery. The total peripheral thickness was significantly thicker than the baseline thickness after PPV alone (P < 0.001; 18 eyes), PPV combined with intravitreal TA injection (IVTA; P = 0.011; 19 eyes), and PPV combined with sub-tenon TA injection (STTA; P = 0001; 23 eyes). The total peripheral thickness in the PPV group at 3 days after surgery was significantly thicker than that of the PPV + IVTA (P = 0.015) and of the PPV + STTA groups (P = 0.016). Multiple linear regression analyses showed that the injection of TA by the two routes and the number of photocoagulation burns were significantly correlated with the total peripheral thicknesses at 3 days after the surgery. The results indicate that the PPV with large number of intraoperative scatter photocoagulation burns caused an increase in the total peripheral thickness and an administration of either IVTA and STTA can reduced the degree of thickening.
-
5.
Evaluation of the effect of combined intravitreal ranibizumab injection and sub-tenon steroid injection in the treatment of resistant diabetic macular edema.
Eriş, E, Perente, I, Vural, E, Vural, A, Seymen, Z, Celebi, ARC, Erdogan, G, Ozkaya, A, Artunay, O
International ophthalmology. 2019;(7):1575-1580
Abstract
PURPOSE To compare sub-tenon steroid plus anti-VEGF injection with anti-VEGF injection solely in the treatment of resistant diabetic macular edema (DME). METHOD Patients who exhibited insufficient anatomic [over 350 μm central macular thickness (CMT)] and less than 3 lines of visual gain at least six anti-VEGF injections, were randomly divided into two groups. In group I, the anti-VEGF injection was performed 10 days after the sub-tenon steroid injection [Triamcinolone acetonide (Sinakort-A®)]. And anti-VEGF was performed when needed during the follow-up period. In group II, treatment was continued with anti-VEGF only. All patients' visual acuity and CMT were followed up for 6 months. RESULTS The baseline BCVA in group I and group II was 0.51 ± 0.667 logMAR and 0.47 ± 0.60 logMAR, respectively (p = 0.52). In group I and II, at the end of 6-month follow-up, BCVA improved to 0.38 ± 0.60 logMAR (p < 0.001) and 0.43 ± 0.60 logMAR (p = 0.20), respectively. The baseline CMT in group I and group II was 494 ± 118.32 and 438.20 ± 90.99 μm, respectively (p = 0.029). In group I and II, at the end of 6 months, CMT decreased to 302.57 ± 69.89 μm (p < 0.001) and 439.20 ± 107.6 μm (p = 0.96), respectively. CONCLUSION Adding steroid to routine anti-VEGF treatment is an effective way of treatment method for resistant DME.
-
6.
Flare levels after intravitreal injection of ranibizumab, aflibercept, or triamcinolone acetonide for diabetic macular edema.
Morioka, M, Takamura, Y, Yamada, Y, Matsumura, T, Gozawa, M, Inatani, M
Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie. 2018;(12):2301-2307
Abstract
PURPOSE To evaluate anterior flare intensity (AFI) and central retinal thickness (CRT) values after intravitreal injection of aflibercept (IVA), ranibizumab (IVR), or triamcinolone acetonide (IVTA) in patients with diabetic macular edema (DME). METHODS This research was conducted as a prospective study for patients with DME. Patients with phakia received either IVA or IVR, whereas patients with pseudophakia received IVA, IVR, or IVTA. AFI and CRT were measured using a laser flare meter and spectral domain optical coherence tomography, respectively, at days 0, 1, 7, 30, and 90. RESULTS Forty patients with phakia and 60 patients with pseudophakia were enrolled this study. In the IVTA group, AFI of pseudophakic eyes was significantly decreased at days 1 (p = 0.0487), 7 (p = 0.0201), and 30 (p = 0.0211). In the IVA group, AFI of phakic eyes was transiently increased at day 1 (p = 0.0078) and returned to baseline at day 7, whereas no significant change was observed in AFI of pseudophakic eyes. In the IVR group, there was no significant change in AFI regardless of phakic condition. All groups showed significant reduction in CRT at day 7 and later. CONCLUSION DME improved after treatment by IVTA, IVR, or IVA, whereas AFI was reduced only in eyes treated with IVTA. The temporal profiles of AFI are likely related to differences in the pharmacological properties of the drugs.
-
7.
Detailed analysis of retinal morphology in patients with diabetic macular edema (DME) randomized to ranibizumab or triamcinolone treatment.
Karst, SG, Lammer, J, Mitsch, C, Schober, M, Mehta, J, Scholda, C, Kundi, M, Kriechbaum, K, Schmidt-Erfurth, U
Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie. 2018;(1):49-58
-
-
Free full text
-
Abstract
PURPOSE Our purpose was to compare the impact in diabetic macula edema (DME) of two intravitreal drugs (0.5 mg ranibizumab vs. 8 mg triamcinolone) on changes in retinal morphology in spectral-domain optical coherence tomography (SD OCT) images, color fundus photography (CF) and fluorescein angiography (FA) images during a 1-year follow-up. METHODS Post hoc analysis was conducted of morphologic characteristics in OCT, FA and CF images of eyes with a center involving DME that were included in a prospective double-masked randomized trial. Eligible patients were divided at random into two groups receiving either pro re nata treatment with 0.5 mg ranibizumab or 8 mg triamcinolone after a fixed loading dose. OCT and CF images were acquired at monthly visits and FA images every three months. RESULTS Twenty-five eyes of 25 patients (ranibizumab: n = 10; triamcinolone: n = 15) were included in this study. Patients treated with ranibizumab showed better visual acuity results after 12 months than patients receiving triamcinolone (p = 0.015) although edema reduction was similar (p = 0.426) in both groups. The initial effect on macular edema shedding after a single ranibizumab injection could be amplified with the following two injections of the loading dose. After a single injection of triamcinolone the beneficial initial effect on the macula edema faded within 3 months. Subretinal fluid and INL cystoid spaces diminished early in the course of treatment while fluid accumulation in the ONL seemed to be more persistent in both treatment arms. In FA, the area of leakage diminished significantly in both treatment arms. After repeated injections the morphologic OCT and FA characteristics of the treatment arms converged. CONCLUSIONS Despite the higher dosage of triamcinolone, both therapies were safe and effective for treating diabetic macular edema. Fluid accumulation in the INL and subretinal space was more responsive to therapy than fluid accumulation in the ONL. Clinicaltrials.gov : NCT00682539.
-
8.
Randomized investigator-blinded comparative study of moisturizer containing 4-t-butylcyclohexanol and licochalcone A versus 0.02% triamcinolone acetonide cream in facial dermatitis.
Boonchai, W, Varothai, S, Winayanuwattikun, W, Phaitoonvatanakij, S, Chaweekulrat, P, Kasemsarn, P
Journal of cosmetic dermatology. 2018;(6):1130-1135
Abstract
BACKGROUND Facial dermatitis can result from various conditions, some of which are of a chronic and relapsing nature. The use of topical corticosteroid therapy may lead to additional adverse effects. OBJECTIVE To compare the efficacy of moisturizer containing 4-t-butylcyclohexanol, which acts as a sensitivity regulator, and licochalcone A, an anti-inflammatory agent from the licorice plant Glycyrrhiza inflata, with that of 0.02% triamcinolone acetonide (TA) for the treatment of facial dermatitis. METHODS This was a randomized, prospective, investigator-blinded study. Eighty participants with mild to moderate facial dermatitis were randomly treated with either the test facial moisturizer or 0.02% TA twice daily for the first 2 weeks. For the subsequent 2 weeks, all patients used only the test moisturizer. Clinical assessment by investigators, bioengineering measurements, patients' subjective evaluation, and clinical photography were performed at baseline, week 2, and week 4. RESULTS Both treatments showed a statistically significant improvement with regard to physician clinical assessment, skin hydration, transepidermal water loss, and patient-assessed visual analog scale after 2 and 4 weeks of treatment compared with baseline. The test facial moisturizer produced better skin hydration than TCS. The improvement in TEWL after 4 weeks of using the test moisturizer was comparable with 2-week treatment with 0.02% TA cream. However, subjective evaluation by patients indicated that TA more rapidly improved sensation sensitivity. CONCLUSION The test facial moisturizer was slower than 0.02% TA in improving facial dermatitis, but showed greater benefit in erythema control and skin hydration.
-
9.
Intravitreal bevacizumab alone or combined with 1 mg triamcinolone in diabetic macular edema: a randomized clinical trial.
Riazi-Esfahani, M, Riazi-Esfahani, H, Ahmadraji, A, Karkhaneh, R, Mahmoudi, A, Roohipoor, R, Ghasemi, F, Yaseri, M
International ophthalmology. 2018;(2):585-598
Abstract
PURPOSE To compare the results of intravitreal bevacizumab (IVB) injection alone or in combination with intravitreal 1 mg triamcinolone acetonide (IVT) in center-involved diabetic macular edema. METHODS In this randomized clinical trial study, ninety-two eyes of 46 patients with bilateral center-involved diabetic macular edema and no previous treatment were included in the study. One eye of each patient was randomly assigned to 1.25 mg of IVB injection or combination of 1.25 IVB and 1 mg IVT. Evaluation of best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP) and grading of lens opacity was conducted at baseline, and weeks 2, 4, 6, 8, 12 and 24 after treatment. Retreatment was performed at a 6-week interval whenever indicated based on CMT. RESULTS Between the groups, BCVA changes were not statistically different until 24-week follow-up (P > 0.05), but at 24 weeks after treatment, BCVA improvement was significantly better in IVB group (P = 0.049). Significant CMT reduction was observed in each group along the follow-up period (P = 0.001). The mean CMT reduction was more significant in combination (IVB + IVT) group at 2 weeks of follow-up (P < 0.001), but CMT changes were not significant between the groups at weeks 12th and 24th after injection. Overall, retreatment was applied for 59 eyes up to 24 weeks (33 in the IVB group, 26 in the IVB + IVT group). Among patients with 2 or more injections, number of injections was significantly lower in IVB + IVT group (P = 0.043). Three eyes within IVB + IVT group developed IOP rise beyond 21 mmHg, which were controlled with topical anti-glaucoma medications within 1 week. Changes in lens opacity were not significant between two groups. CONCLUSION Eyes treated with IVB plus 1 mg IVT injections had more significant reduction in CMT in early post-injection, but this effect was transient. Although after 24 weeks visual acuity improvement was better in IVB group, combination therapy may decrease the number of injections. Combining 1 mg of intravitreal triamcinolone with bevacizumab was not accompanied with significant side effects.
-
10.
Effect of intravitreal triamcinolone acetonide injection at the end of vitrectomy for vitreous haemorrhage related to proliferative diabetic retinopathy.
Takamura, Y, Shimura, M, Katome, T, Someya, H, Sugimoto, M, Hirano, T, Sakamoto, T, Gozawa, M, Matsumura, T, Inatani, M, et al
The British journal of ophthalmology. 2018;(10):1351-1357
-
-
Free full text
-
Abstract
BACKGROUND/AIMS: To investigate whether intravitreal injection of triamcinolone acetonide (IVTA) combined with vitrectomy prevents postoperative inflammation in patients with vitreous haemorrhage (VH) due to proliferative diabetic retinopathy (PDR). METHODS This prospective, multicentre, randomised study conducted at seven sites in Japan enrolled patients diagnosed as having VH following PDR. Patients underwent vitrectomy with (IVTA+VIT group) or without (VIT group) IVTA at the end of the surgery. Anterior flare intensity (AFI), central retinal thickness (CRT), best-corrected visual acuity (BCVA) and intraocular pressure (IOP) were measured before and at 3 days, 1 week, 1, 3 and 6 months after surgery and compared. RESULTS Number of patients who completed 6 months of follow-up was 40 and 41 in VIT group and IVTA+VIT group, respectively. AFI was significantly higher in the VIT group than in the IVTA+VIT group at 3 days (P=0.033), 1 week (P=0.019) and 1 month (P=0.037). There were no significant differences in CRT, BCVA and IOP between the groups through the observational periods. In the cases with macular oedema >350 µm of CRT at 3 days, CRT was significantly lower in the IVTA+VIT group than in the VIT group at 1 month (P=0.041). CONCLUSIONS IVTA combined with vitrectomy and cataract surgery contributed to inhibit the postoperative inflammation in patients with VH due to PDR. The effect of IVTA in the reduction of diabetic macular oedema may be limited to the early stage after surgery. TRIAL REGISTRATION NUMBER UMIN000020376, Post-results.