scholarly journals Diabetic macular edema: Safe and effective treatment with intravitreal triamcinolone acetonide (Taioftal)

PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0257695
Author(s):  
Francesco Saverio Sorrentino ◽  
Claudio Bonifazzi ◽  
Francesco Parmeggiani

Purpose To suggest the safety and efficacy of preservative-free triamcinolone acetonide intravitreal injectable suspension (Taioftal) for the treatment of diabetic macular edema. Methods A prospective clinical study involved 49 patients (49 eyes), that were treated with Taioftal and followed-up for six months. Complete ophthalmic examination, including spectral domain optical coherence tomography, was performed at baseline, and at month 1, 3, 6 after the intravitreal injection. Accurate collection and analysis of best-corrected visual acuity (BCVA), central foveal thickness (CFT), intraocular pressure (IOP), and adverse events (AEs) were carried out in order to evaluate visual function and macular morphology before and after treatment Results Median BCVA value chosen as comparing statistics was significantly improved at every follow-up time points (gain of 6 letters at month 1, 12 at month 3 –improvement up to 24% at month 3 with stabilization until month 6) compared to baseline, as certified by Kruskal-Wallis rank sum test (P<0.05). Median CFT significantly waned at each follow-up times (decrease of about 65 μm at month 1, 155 at month 3 –reduction up to 28% at month 3 keeping good outcome until month 6) compared to baseline (P<0.05). IOP elevation, with no severe increases, was the most common among spotted AEs (median of 23 mmHg at month 1, 20 at month 3). Conclusion Intravitreal injection of preservative-free triamcinolone (Taioftal) is an effective, safe and inexpensive drug used to improve visual acuity and reduce central foveal thickness in eyes affected by diabetic macular edema during an average time of 6 months. Temporary, never severe, elevation of IOP is totally manageable with topical medications. No serious vision-threatening complications are related to the use of intravitreal triamcinolone injections.

2016 ◽  
Vol 3 (2) ◽  
pp. 30-34
Author(s):  
Prachand Gautam ◽  
Koshal Shrestha ◽  
Gyanendra Lamichhane ◽  
Sushila Patel

INTRODUCTION: Diabetic retionopathy is a microangilpathy. The present study was done to investigate results of Intravitreal Triamcinolone Acetonide injection for the treatment diffuse diabetic macular edema. MATERIAL AND METHODS: The study included 40 eyes of 40 patients with clinically significant diffuse diabetic macular edema. Eyes were diagnosed with diabetic macular edema according to Early Treatment Diabetic Retinopathy Study guidelines. An Intravitreal injection of Triamcinolone Acetonide at the dose of 4 mg/0.2 ml was administered. Best corrected visual acuity was measured as the logarithm of the minimum angle of resolution (logMAR) and snellen vision drum and size of macular edema (hard exudates) was obtained by slit lamp biomicroscopy using +90 D Volk lens at each visit. Intraocular pressure (IOP) and other complications related with steroid and injection related complications were also evaluated. Subsequently patients were followed up on 1st day, 2nd week and 3rd month. RESULTS: All patients were completed second follow up at 3 months. The mean size of macular edema, which obtained at 3 months postoperatively, was significantly different from the baseline measurement from 1.4125 to 0.9474 DD. Mean visual acuity improved significantly from baseline at 3 months of follow up was 0.7421 LogMAR (≈ 6/30 in Snellen chart). Eleven eyes developed intraocular pressure higher than 21 mmHg at 2nd week postoperatively. Other drug and injection related complications were not developed. Increased IOP were controlled with anti glaucoma drugs. CONCLUSIONS: Intravitreal Triamcinolone was a promising therapeutic method for diabetic macular edema. TriamcinoloneAcetonide effectively reduces size of macular edema and improves visual acuity in the short term.Journal of Universal College of Medical Sciences (2015) Vol.03 No.02 Issue 10 Page: 30-34


2005 ◽  
Vol 15 (5) ◽  
pp. 619-626 ◽  
Author(s):  
H.K. Tewari ◽  
P. Sony ◽  
R. Chawla ◽  
S.P. Garg ◽  
P. Venkatesh

Purpose To evaluate the effect of intravitreal triamcinolone acetonide on visual acuity and macular thickness using optical coherence tomography (OCT) in macular edema associated with various retinal vascular disorders. Methods This prospective nonrandomized clinical interventional study included 81 eyes (76 patients) comprised of Group I, 57 eyes (51 patients) with diabetic macular edema; Group II, 10 eyes (10 patients) with branch retinal vein occlusion; and Group III, 13 eyes (13 patients) with central retinal vein occlusion. All eyes received an intravitreal injection of 4 mg triamcinolone acetonide (with the solvent) in the operation theater under sterile conditions. Results Mean preinjection central macular thickness was 531.84±132 μm in Group I, 458.4±149 μm in Group II, and 750.81±148 μm in Group III. All groups showed a statistically significant decrease in mean central macular thickness at 1 month (300.7±119 μM in Group I, 218.2±99 μm in Group II, and 210.5 ±56 μm in Group III) and 3 months (253.19±109 μm in Group I, 187±47 μm in Group II, and 182±50 μm in Group III) after injection (p<0.05). Mean follow-up was 22±2.4 weeks. Mean visual acuity increased in all three groups (preoperative visual acuity in Group I, 1.2±0.4 logMAR units; Group II, 1.24±0.5 logMAR units; Group III, 1.1 ±0.4 logMAR units; 1 month postinjection in Group I, 0.88±0.3 logMAR units; Group II, 0.67±0.3 logMAR units; Group III, 0.86±0.4 logMAR units; 3 months postinjection in Group I, 0.84±0.4 logMAR units; Group II, 0.59±0.3 logMAR units; Group III, 0.82±0.5 logMAR units) (p<0.05). Forty-one eyes completed 6 months and 20 eyes completed 9 months follow-up. Twelve of 20 (41%) eyes in Group I, 2/6 (33%) eyes in Group II, 3/6 (50%) eyes in Group III, and 8/15 (53%) eyes in Group I, 1/3 (33%) eyes in Group II, and 2/2 (100%) eyes in Group III developed recurrence of macular edema with worsening of visual acuity at 6 and 9 months, respectively. Thirty-three (40.7%) eyes developed IOP elevation (at least one reading > 24 mmHg). One eye developed infective endophthalmitis. Conclusions Intravitreal injection of triamcinolone acetonide may be considered as an effective treatment for reducing macular thickening due to diffuse diabetic macular edema, venous occlusion associated macular edema, and may result in increase in visual acuity at least in the short term. Further follow-up and analysis is required to demonstrate its long-term efficacy.


2020 ◽  
Vol 12 ◽  
pp. 251584142091776
Author(s):  
Angela Carneiro ◽  
Angelina Meireles ◽  
João Paulo Castro Sousa ◽  
Carla Teixeira

Introduction: The ILUVIEN® (fluocinolone acetonide) Clinical Evidence in Portugal (ICE-PT) study is a retrospective, multicenter, observational study evaluating the effectiveness and safety of the FAc implant in patients with diabetic macular edema. Methods: Patients included in this study had received the 0.2 µg/day fluocinolone acetonide implant for the treatment of diabetic macular edema and had measurements of visual acuity and retinal thickness assessed by optical coherence tomography for at least 12 months pre- and post-fluocinolone acetonide implant administration, with ⩾2 follow-up visits. Outcomes measured included visual acuity, central foveal thickness, and intraocular pressure. Results: There was a significant increase in mean visual acuity compared with baseline at 3, 6, 9, and 12 months post-fluocinolone acetonide in both the overall study population and the pseudophakic subgroup ( p < 0.05 at all time points in both groups). A significant reduction in mean central foveal thickness compared with baseline was seen in the overall study population at 3, 6, 9, and 12 months post-fluocinolone acetonide ( p < 0.05 at all time points). At 12-month post-fluocinolone acetonide, a small but significant intraocular pressure increase of 1.0 mmHg was seen in the overall study population. Conclusion: The results of this analysis show that switching from the current standard of care to the fluocinolone acetonide implant leads to beneficial effects in terms of vision and retinal structure in patients with diabetic macular edema and that patients benefited from FAc implant administration, regardless of lens status.


Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 322
Author(s):  
Jose Navarro-Partida ◽  
Juan Carlos Altamirano-Vallejo ◽  
Alejandro Gonzalez-De la Rosa ◽  
Juan Armendariz-Borunda ◽  
Carlos Rodrigo Castro-Castaneda ◽  
...  

Intravitreal injections (IVTs) of corticosteroids as triamcinolone acetonide (TA) are frequently used for the treatment of many vitreous and retinal disorders. However, IVTs are related to severe ocular complications. Lately, a topical ophthalmic TA-loaded liposomes formulation (TALF) was designed to transport TA into the posterior segment of the eye when instilled on the ocular surface. To evaluate the safety, tolerability, and biological activity of TALF, an animal study and a phase I clinical assay were performed. Moreover, four patients with diabetic macular edema (DME) were treated with TALF in order to explore the biological activity of the formulation. No inflammation, lens opacity, swelling, or increase in intraocular pressure were recorded after the instillation of TALF in any of the animal or clinical studies. Mainly, mild and transient adverse events such as dry eye and burning were reported. TALF significantly improves visual acuity and diminishes central foveal thickness in patients with DME. The current data demonstrate the safety, tolerability, and biological activity of TALF. It seems that TALF can be used topically to treat vitreous and retinal diseases that respond to TA such as DME, avoiding the use of corticosteroid IVTs and their associated hazards.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Bernardete Pessoa ◽  
João Leite ◽  
João Heitor ◽  
João Coelho ◽  
Sérgio Monteiro ◽  
...  

AbstractTo evaluate the role of the vitreous in the management of diabetic macular edema with ranibizumab intravitreal injections in a pro re nata regimen. Prospective study of 50 consecutive eyes with diabetic macular edema treated with ranibizumab and 12 months of follow-up. Primary endpoint: to assess differences between non-vitrectomized and vitrectomized eyes in the number injections needed to control the edema. Secondary endpoints: comparison of groups regarding best corrected visual acuity, central foveal thickness and thickness of seven retinal layers. 46 eyes from 38 patients, 10 vitrectomized and 36 non-vitrectomized, completed the follow-up. At month 12, the two groups achieved an equivalent anatomical outcome and needed a similar number of ranibizumab intravitreal injections. In vitrectomized eyes final visual acuity was worse when baseline retinal nerve fiber layers in the central foveal subfield were thicker, showing a strong correlation (r = − 0.942, p < 0.001). A similar, albeit moderate correlation was observed in non-vitrectomized eyes (r = − 0.504, p = 0.002). A decrease of retinal nerve fiber layers inner ring thickness was correlated with a better final visual acuity only in vitrectomized eyes (r = 0.734, p = 0.016). The effect of diabetic macular edema seems to be worse in vitrectomized eyes, with a thinner inner retina reservoir.Clinicaltrials.govNCT04387604.


Author(s):  
Jose Navarro-Partida ◽  
Juan Carlos Altamirano-Vallejo ◽  
Alejandro Gonzalez-De la Rosa ◽  
Juan Armendariz-Borunda ◽  
Carlos Rodrigo Castro-Castaneda ◽  
...  

Intravitreal injections (IVTs) of corticosteroids as triamcinolone acetonide (TA) are frequently used for the treatment of many vitreous and retinal disorders. However, IVTs are related to severe ocular complications. Lately, a topical ophthalmic TA loaded liposomes formulation (TALF) was designed to transport TA into the posterior segment of the eye when instilled in the ocular surface. To evaluate the safety, tolerability, and biologic activity of TALF, an animal study and a phase I clinical assay was performed. Moreover, four patients with diabetic macular edema (DME) were treated with TALF in order to explore the biologic activity of the formulation. No inflammation, lens opacity, swelling or intraocular pressure rising were recorded after the instillation of TALF in any of the animal or clinical study. Mainly, mild and transient adverse events such as dry eye (30%) and burning (30%) were reported. TALF improves significantly visual acuity and diminishes central foveal thickness in patients with DME. The current data demonstrate the safety, tolerability, and biologic activity of TALF. It seems that TALF can be used topically to treat vitreous and retinal diseases that respond to TA such as DME, avoiding the use of corticosteroids IVTs and its associated hazards.


2021 ◽  
Author(s):  
Yuan Tao ◽  
Mingrong Kou ◽  
Xia Yang ◽  
Yixiao Li ◽  
Shuting Li ◽  
...  

Abstract Background: This study aimed to assess efficacy differences of aflibercept by intravitreal injection for diabetic macular edema (DME) with different OCT types. Methods: according to OCT morphology, 128 patients (128 eyes) with DME were divided into the diffuse retinal thickening (DRT; 41 patients, 41 eyes), cystoid macular edema (CME; 47 patients, 47 eyes), and serous retinal detachment (SRD; 40 patients, 40eyes) groups. All patients were treated by intravitreal injection of 0.5 mg (0.05 mL) aflibercept according to the 3+prn regimen. BCVA (LogMAR) and central foveal thickness (CFT) among the three groups at baseline, and 1 month, 3 months, 6 months and 12 months after treatment, respectively, were assessed. Results: At 1 month, 3 months, 6 months and 12 months after treatment, improvements in BCVA and CFT in the three groups showed statistical significance (P<0.05). BCVA improvement was better at all time points in the DRT group compared with the SRD group (P<0.05). BCVA improvement was also better in the CME group compared with the SRD group at 6 months and 12 months post-treatment (P<0.05). At 1 month, 3 months and 6 months after treatment, CFT differences among the three groups had no statistical significance (P>0.05), while at 12 months post-treatment, CFT values among the three groups had significant differences (F=3.77, P=0.0269). at 12 months after treatment, CFT improvement was better in the DRT and CME groups compared with the SRD group (P<0.05). Conclusion: aflibercept by intravitreal injection could significantly improve visual acuity in DME patients with different OCT types and reduce CFT. At the initial treatment of 12 months, CFT and BCVA improvements in the DRT and CME types were the most pronounced.


2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Solmaz Abdolrahimzadeh ◽  
Vito Fenicia ◽  
Maurizio Maurizi Enrici ◽  
Pasquale Plateroti ◽  
Dora Cianfrone ◽  
...  

The clinical efficacy of one or two intravitreal injections of a continued deliverance dexamethasone 700 μg implant in ten patients with persistent macular edema following uncomplicated phacoemulsification was evaluated. Complete ophthalmological examination and spectral domain optical coherence tomography were carried out. Follow-up was at day 7 and months 1, 2, 4, 6, 8, and 12. At baseline mean best corrected visual acuity was 62 Early Treatment Diabetic Retinopathy Study Chart letters, which showed statistically significant improvement at each follow-up, except at month 6, to reach 79 letters at month 12 (P=0.018). Prior to treatment mean central foveal thickness was 622 μm, which showed statistically significant improvement at each follow-up to reach a mean value of 282 μm (P=0.012) at month 12. Five patients received a second dexamethasone implant at month 7. Two patients were excluded from the study at months 4 and 8. Intraocular pressure remained stable during the study period with the exception of mild increase in two patients requiring topical therapy. In conclusion there was statistically significant improvement of best corrected visual acuity and mean central foveal thickness with one or two intravitreal dexamethasone implants over 12 months.


2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Yijun Hu ◽  
Qiaowei Wu ◽  
Baoyi Liu ◽  
Manqing Huang ◽  
Qingsheng Peng ◽  
...  

Purpose. To evaluate the impact of restoration of foveal bulge (FB) in optical coherence tomography (OCT) images on visual acuity after resolution of diabetic macular edema with coexisting serous retinal detachment (SRD-DME). Methods. A total of 52 eyes with resolved SRD-DME and an intact ellipsoid zone at the central fovea were included. All eyes underwent best-corrected visual acuity (BCVA) examination and OCT scanning at baseline and follow-up visits (1, 3, and 6 months). The eyes were divided into two groups according to the presence of FB at 6 months. BCVA, central foveal thickness (CFT), height of SRD (SRDH), outer nuclear layer (ONL) thickness, photoreceptor inner segment (PIS), and outer segment (POS) length were compared between the two groups. Results. A FB was found in 25 of 52 (48%) eyes at 6 months. The FB (+) group had lower SRDH at baseline, and better BCVA, longer POS length at 6 months (all P<0.05). There was no significant difference in the CFT, ONL thickness, and PIS length at 6 months between the two groups (all P>0.05). More eyes in the FB (+) group had complete SRD resolution at 1 month (P=0.009) and 3 months (P=0.012). Eyes with complete SRD resolution at 1 month (P=0.009) or 3 months (P=0.012) were more likely to have a FB at 6 months. Conclusions. The Presence of the FB is associated with better BCVA after resolution of SRD-DME. Eyes with lower baseline SRDH or faster SRD resolution are more likely to have a FB at 6 months.


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