scholarly journals Five-year outcomes of eyes initially enrolled in the 2-year BEVORDEX trial of bevacizumab or dexamethasone implants for diabetic macular oedema

2021 ◽  
pp. bjophthalmol-2021-319839
Author(s):  
Elisa E Cornish ◽  
Kelvin YC Teo ◽  
Mark C Gillies ◽  
Lyndell L Lim ◽  
Vuong Nguyen ◽  
...  
Keyword(s):  
Cataract Surgery ◽  
Macular Oedema ◽  
Clinical Care ◽  
Diabetic Macular Oedema ◽  
Standard Of Care ◽  
Similar Proportion ◽  
Treatment Groups ◽  
Post Trial ◽  
Intravitreal Dexamethasone ◽  
Anatomical Outcomes

BackgroundThe BEVORDEX trial compared outcomes of eyes with diabetic macular oedema (DMO) randomised to receive either intravitreal dexamethasone (DEX-) implant or bevacizumab over 2 years. We assessed long-term efficacy and safety outcomes 5 years from enrolment.MethodsPatients received standard clinical care after they finished the study. Their files were reviewed for visual and anatomical outcomes, post-trial treatments and complications.ResultsThree-year and five-year data were available for 82% and 59% of eyes enrolled in the BEVORDEX study, respectively. Visual acuity gains at end of trial were generally lost by both treatment groups at 5 years but the macular thickness did not change from end of trial to 5 years. A similar proportion of eyes from each treatment group gained ≥10 letters at 5 years from enrolment in the BEVORDEX trial.Eyes that were initially randomised to the DEX-implant group had significantly fewer treatments but were more likely to develop proliferative diabetic retinopathy (PDR) over the 5-year period compared with eyes initially randomised to bevacizumab. The proportion of eyes that had cataract surgery by 5 years was similar between initial treatment groups.ConclusionsEyes in the BEVORDEX trial had similar 5-year rates of cataract surgery, however, more eyes converted to PDR in the group initially treated with DEX-implant. Eyes that were initially treated for 2 years with either intravitreal DEX-implant of bevacizumab followed by standard of care had similar visual and anatomical outcomes at 5 years.

Recommendations for the management of diabetic macular oedema with intravitreal dexamethasone implant: A national Delphi consensus study

2021 ◽  
pp. 112067212110528
Author(s):  
Laurent Kodjikian ◽  
Stephanie Baillif ◽  
Aude Couturier ◽  
Catherine Creuzot-Garcher ◽  
Marie-Noelle Delyfer ◽  
...  
Keyword(s):  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Daily Practice ◽  
Dexamethasone Implant ◽  
Consensus Approach ◽  
Delphi Consensus ◽  
First Line ◽  
Anti Vegf ◽  
Intravitreal Dexamethasone Implant ◽  
Intravitreal Dexamethasone

Purpose The intravitreal dexamethasone implant (DEX-I) is an alternative to anti-VEGF for the first-line treatment of diabetic macular oedema (DME). However, several questions remain regarding its routine use and its place in certain situations not always specified in current recommendations. A national consensus approach was, therefore, initiated by French retinal experts. Methods An iterative Delphi consensus approach was used. A steering committee (SC) of seven experts analysed data from the literature to formulate statements divided into five key areas of treatment. These statements were submitted to the independent and anonymous electronic vote of 87 French retina experts among whom 39 expressed their opinion and therefore constituted the voting panel. Results After two rounds of voting, 22 and 7 of 38 statements received a strong consensus and a good consensus, respectively. The consensus level was higher for statements regarding first-line indications and safety of DEX-I compared to those regarding efficacy assessment, reprocessing time or pathophysiological biomarkers. The panellists recommended the preferential use of DEX-I for patients with limited availability for multiple injections, those who needed to undergo cataract surgery or who had a recent cardiovascular history, and as a therapeutic alternative to anti-VEGF in patients with a history of vitrectomy, retinal serous detachment, hyper-reflective points or dry exudates in optical coherence tomography (OCT). However, some statements proposed by SC experts were not validated. Conclusion This study provides some key recommendations to clinicians treating diabetic macular oedema, which may be useful when using intravitreal dexamethasone implants in daily practice.

scholarly journals Triamcinolone Acetonide for the Treatment of Diabetic Macular Oedema

2010 ◽  
Vol 8 (1) ◽  
pp. 42
Author(s):  
Valentina Sarao ◽  
Daniele Veritti ◽  
Paolo Lanzetta ◽  
◽  
◽  
...  
Keyword(s):  
Triamcinolone Acetonide ◽  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Standard Of Care ◽  
Blood Retinal Barrier ◽  
Intravitreal Triamcinolone ◽  
Duration Of Action ◽  
Routes Of Administration ◽  
Severe Visual Loss ◽  
Randomised Controlled

Diabetic macular oedema is a major cause of severe visual loss whose pathogenesis appears to be complex and multifactorial. For many years laser photocoagulation has been the standard of care for the treatment of this condition. Emerging pharmacologic approaches are being evaluated through randomised controlled trials. Triamcinolone acetonide has been proposed as a promising option, due to its well-known anti-inflammatory, anti-permeability and anti-angiogenic properties. Intravitreal delivery allows bypassing of the blood–retinal barrier to achieve a more concentrated dose of steroid in the vitreal cavity for a prolonged time. Intravitreal triamcinolone acetonide is effective in reducing central macular thickness and improving visual acuity, even if the duration of action is often provisional and requires repeated injections. Drug-related and injection-related side effects have been reported; the most common are induced cataract and increased intraocular pressure. To extend the duration of steroid effects and to minimise the risk of complications, alternative routes of administration and extend-release implants are being investigated.

Aflibercept – Setting its Sights on Diabetic Macular Oedema

2014 ◽  
Vol 08 (02) ◽  
pp. 152
Author(s):  
Jean-François Korobelnik ◽  
Reinier Schlingemann ◽  
Ian Pearce ◽  
◽  
◽  
...  
Keyword(s):  
Macular Oedema ◽  
Large Scale ◽  
Fluid Transport ◽  
Diabetic Macular Oedema ◽  
Standard Of Care ◽  
Glycated Haemoglobin ◽  
Vascular Endothelial ◽  
Significant Efficacy ◽  
Endothelial Growth Factor

A satellite symposium entitled ‘Aflibercept* – Setting Its Sights On Diabetic Macular Oedema (DMO)’ was chaired by Jean-François Korobelnik and was convened at the 2014 European Association for Vision and Eye Research (EVER) Congress. The symposium discussed the science behind DMO, in particular, the role of vascular endothelial growth factor (VEGF) and associated inflammatory mechanisms that alter fluid transport from capillaries into retinal tissues leading to focal leakage, fluid accumulation, macular damage and eventual blindness. This discussion of the pathophysiology emphasised the importance of VEGF as a target for DMO treatments. Management of diabetes and prevention of progression of diabetic retinopathy leading to DMO requires strict control of glycated haemoglobin (HbA1c), blood pressure and lipid levels. Once DMO has developed and vision is impaired, the anti-VEGF agents have emerged as vital components of disease management and are becoming the first-line standard of care. Aflibercept (EYLEA®) and ranibizumab (Lucentis®) are approved agents for DMO and have shown significant efficacy in clinical trials in terms of visual acuity gains, decreased retinal thickness and have good safety profiles. The symposium finally focused on the use of aflibercept in DMO. In large-scale trials (VIVID and VISTA), this treatment has been compared head-to-head with laser treatment and during 1 year of treatment, showed substantial efficacy benefits, no new safety signals and the potential for lower frequency intravitreal dosing at 8- rather than 4-week intervals for monitoring andpro re natadosing.

Predictive imaging biomarkers relevant for functional and anatomical outcomes during ranibizumab therapy of diabetic macular oedema

2017 ◽  
Vol 102 (2) ◽  
pp. 195-203 ◽  
Author(s):  
Bianca S Gerendas ◽  
Sonja Prager ◽  
Gabor Deak ◽  
Christian Simader ◽  
Jan Lammer ◽  
...  
Keyword(s):  
Macular Oedema ◽  
Negative Impact ◽  
Positive Impact ◽  
Combined Therapy ◽  
Subretinal Fluid ◽  
Diabetic Macular Oedema ◽  
Therapy Response ◽  
Predictor Variables ◽  
Imaging Biomarkers ◽  
Anatomical Outcomes

Background/aimsThe objective is to identify imaging biomarkers in optical coherence tomography predicting functional/anatomical outcomes in diabetic macular oedema (DMO).MethodsThe presented study is a post hoc analysis of the RESTORE/RESTORE-extension studies. Best-corrected visual acuity (BCVA) was analysed using general estimating equation models using treatment group/morphological features as predictor variables. In addition, linear multiple regression models analysed BCVA gain up to 12 and 36 months with BCVA/morphological baseline characteristics as independent predictor variables. The correlations between central retinal thickness (CRT)/BCVA were calculated as Spearman’s/Pearson’s correlation coefficients.ResultsA weak negative linear correlation between CRT/BCVA was observed in all study arms at baseline (r=−0.34, p<0.001) and at month 36 (r=−0.26, p<0.001). Patients with baseline height of intraretinal cystoid fluid (IRC) ≤380 µm had better baseline BCVA compared with patients with IRC height >380 µm (64.84±10.63 vs 61.66±9.92 letters; p=0.0071, respectively), which was maintained until the end of month 12 (70.5±12.33 vs 67.0±14.09 letters; p=0.0252, respectively). With laser, there was a trend for patients with subretinal fluid (SRF) at baseline to lose BCVA letters at month 12 (−5.38±16.54 vs 2.49±9.72 letters; p=0.1038), whereas ranibizumab patients trended towards higher BCVA gains (10.28±7.14 vs 6.76±7.67; p=0.0563), compared with those without SRF. With combined therapy, all patients had similar BCVA gains regardless of SRF (p=0.3768).ConclusionWith ranibizumab treatment, the height of IRC spaces at baseline was a better predictor of functional/anatomical improvement than CRT alone. There was also a trend for SRF to show a positive impact on ranibizumab therapy response and a negative impact on laser therapy response.

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