A randomized clinical trial comparing fixed vs pro-re-nata dosing of Ozurdex in refractory diabetic macular oedema (OZDRY study)

Background/aimsThe RELIGHT clinical trial used an individualised treatment regimen of ranibizumab to treat diabetic macular oedema (DMO). We report findings from two patient-reported outcome instruments.MethodsThe National Eye Institute Visual Function Questionnaire (NEI-VFQ) was administered before starting treatment (M0) and at M6, 12 and 18. The Macular Disease Society Treatment Satisfaction Questionnaire (MacTSQ) was administered 1 month after treatment start (M1) and at M6, 12 and 18. Relationships between best-corrected visual acuity (BCVA) in the study eye (SE) and the status of the eye at baseline (as better or worse eye by BCVA) and the two instrument measures were investigated.ResultsBCVA in the SE correlated strongly with the NEI-VFQ composite scores and the majority of the subscales but not with the MacTSQ subscales. Statistically significant improvements were observed in the majority of the subscales of the NEI-VFQ at M6, 12 and 18. For the MacTSQ, improvements between baseline M6, 12 and 18 were seen for subscale 1 but only reached statistical significance at M12. In subscale 2, the changes in mean scores were statistically significant at all timepoints.ConclusionsAlthough ranibizumab treatment in DMO over an 18-month period resulted in improvements in visual functioning and patient satisfaction, no correlation was found between the instruments used to measure these outcomes. Our finding of a lack of correlation between BCVA and the MacTSQ suggests the presence of psychophysical factors not measured by traditional means.

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Short-term vision gains at 12 weeks correlate with long-term vision gains at 2 years: results from the BEVORDEX randomised clinical trial of bevacizumab versus dexamethasone implants for diabetic macular oedema

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2017-310737 ◽

2017 ◽

Vol 102 (4) ◽

pp. 479-482 ◽

Cited By ~ 5

Author(s):

Hemal Mehta ◽

Samantha Fraser-Bell ◽

Vuong Nguyen ◽

Lyndell L Lim ◽

Mark C Gillies

Keyword(s):

Clinical Trial ◽

Macular Oedema ◽

Diabetic Macular Oedema ◽

Randomised Clinical Trial ◽

Macular Thickness ◽

Central Macular Thickness ◽

Short Term ◽

Treatment Allocation ◽

Visual Outcomes

AimTo determine whether early vision gains predict long-term visual outcomes in the BEVORDEX randomised clinical trial of bevacizumab or dexamethasone implants for diabetic macular oedema.MethodsPost hoc analysis of 68 study eyes (77%) that completed 2 years follow-up of the BEVORDEX multicentre randomised clinical trial set in Australia (ClinicalTrials.gov identifier: NCT01298076). Study eyes from both groups were combined and stratified by visual acuity (VA) change in the first 12 weeks in to three groups: (a) suboptimal gain: <5 letters gain (includes VA loss), (b) moderate gain: 5–9 letters gain, (c) pronounced gain: ≥10 letters gain. This was correlated with VA outcome at 104 weeks taking into account treatment allocation and baseline lens status.ResultsThe change in VA in the first 12 weeks was significantly correlated with VA change at 104 weeks (p<0.001). This was independent of treatment allocation (p=0.353) and lens status at baseline (p=0.593). The change in central macular thickness at 12 weeks did not correlate with VA gain at 104 weeks (p=0.847).ConclusionShort-term visual gain at 12 weeks was strongly correlated with long-term vision improvement independent of treatment allocation or baseline lens status. Early improvement in central macular thickness was not predictive of long-term visual outcomes.Trial registration numberNCT01298076, Post-results.

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A prospective randomised controlled clinical trial comparing a combination of repeated intravitreal Ozurdex and macular laser therapy versus macular laser only in centre-involving diabetic macular oedema (OZLASE study)

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2015-307136 ◽

2015 ◽

Vol 100 (6) ◽

pp. 802-807 ◽

Cited By ~ 10

Author(s):

Ling Zhi Heng ◽

Sobha Sivaprasad ◽

Roxanne Crosby-Nwaobi ◽

Zubin Saihan ◽

Mike Karampelas ◽

...

Keyword(s):

Clinical Trial ◽

Laser Therapy ◽

Macular Oedema ◽

Diabetic Macular Oedema ◽

Controlled Clinical Trial ◽

Randomised Controlled Clinical Trial ◽

Randomised Controlled

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Prospective randomised clinical trial of intravitreal bevacizumab versus triamcinolone in eyes with diabetic macular oedema undergoing cataract surgery: 6-month results

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2018-313437 ◽

2019 ◽

pp. bjophthalmol-2018-313437 ◽

Cited By ~ 3

Author(s):

Rathika Kandasamy ◽

Marios Constantinou ◽

Sophie L Rogers ◽

Sukhpal Singh Sandhu ◽

Sanjeewa Wickremasinghe ◽

...

Keyword(s):

Clinical Trial ◽

Cataract Surgery ◽

Macular Oedema ◽

Diabetic Macular Oedema ◽

Intravitreal Bevacizumab ◽

Randomised Clinical Trial ◽

Sustained Improvement ◽

Significant Difference ◽

To Receive ◽

Significant Cataract

AimTo 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).MethodsProspective, 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.Results61 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).ConclusionsWhen 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.

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An Evidence-based Approach to Using Intravitreal Steroids in the Management of Diabetic Macular Oedema

European Ophthalmic Review ◽

10.17925/eor.2017.11.01.44 ◽

2017 ◽

Vol 11 (01) ◽

pp. 44

Author(s):

Mehmet Ozturk ◽

Martin L Harris ◽

Hemal Mehta ◽

◽

...

Keyword(s):

Clinical Trial ◽

Real World ◽

Macular Oedema ◽

Visual Loss ◽

Diabetic Macular Oedema ◽

Clinical Trial Data ◽

Glaucoma Surgery ◽

Real World Evidence ◽

Working Age ◽

Endothelial Growth Factor

Diabetic macular oedema (DMO) is the leading cause of acquired visual loss in the working age population. The landscape for DMO treatment has changed significantly over the past decade. Macular laser has been reported to reduce the risk of moderate visual loss in seminal clinical trials from the 1980s, but relatively few patients achieved visual gain. With the advent of intravitreal pharmacotherapy it is now possible to achieve visual gains in the majority of patients. Intravitreal anti-vascular endothelial growth factor (VEGF) agents are now a first-line treatment option in centre-involving DMO. This review assesses clinical trial and more recent real-world evidence to guide clinicians as to when intravitreal steroids should be considered in the management of DMO. In particular, intravitreal steroids can be considered in pseudophakic patients, or those due to undergo cataract surgery, in patients unable to attend for regular intravitreal procedures, and non-responders to intravitreal anti-VEGF therapy. Assessing clinical trial data, the dexamethasone implant appears to have a more predictable intraocular rise profile than triamcinolone or fluocinolone with a lower requirement for incisional glaucoma surgery. There is a need for consensus regarding real-world outcome measures for intravitreal steroids in the management of DMO to allow easier comparison across studies.

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Changing Perspectives in Diabetic Macular Oedema – Recognising and Understanding Chronic Diabetic Macular Oedema

European Ophthalmic Review ◽

10.17925/eor.2014.08.02.145 ◽

2014 ◽

Vol 08 (02) ◽

pp. 145

Author(s):

Usha Chakravarthy ◽

Albert Augustin ◽

Yit Yang ◽

Michael Diestelhorst ◽

Pascale Massin ◽

...

Keyword(s):

Clinical Trial ◽

Macular Oedema ◽

Diabetic Macular Oedema ◽

Clinical Trial Data ◽

Fluocinolone Acetonide ◽

Phase Iii ◽

Real World Data ◽

First Line Therapy ◽

Line Therapy ◽

Phase Iii Trials

The satellite symposium moderated by Usha Chakravarthy entitled ‘Changing Perspectives in Diabetic Macular Oedema: Recognising and Understanding Chronic Diabetic Macular Oedema’ was convened at the 2014 EURETINA Congress. The symposium discussed the multiple processes involved in chronic diabetic macular oedema (DMO) and the use of medications, in particular, corticosteroids in its management. As DMO progresses, inflammatory cytokines are up-regulated relative to vascular endothelial growth factor (VEGF) and these promote various pathways that ultimately result in retinal damage in chronic disease. It is important therefore that treatments for chronic DMO address this altered inflammatory cytokine profile to effectively manage the condition. ILUVIEN®, a 190 μg intravitreal implant in applicator (with a daily release rate of 0.2 μg/day fluocinolone acetonide [FAc] implant) is a second-line therapy indicated for the treatment of chronic DMO. This implant has been shown in phase III trials to lead to marked improvements in visual acuity and in retinal thickness in patients with chronic DMO that were insufficiently response to first-line therapy (i.e. laser). Clinical trial data strongly support the use of the FAc implant in chronic DMO and now ‘real world’ data from its use in regular clinical practice are becoming available and interim results complement those reported in a clinical trial setting.

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