Association Between Early Anatomic Response to Anti–vascular Endothelial Growth Factor Therapy and Long-Term Outcome in Diabetic Macular Edema

Dugel, Pravin U.; Campbell, Joanna; Kiss, Szilárd; Loewenstein, Anat; Shih, Vanessa; Xu, Xiaoshu; Holekamp, Nancy M.; Augustin, Albert J.; Ho, Allen C.; González, Víctor H.; Whitcup, Scott M.

doi:10.1097/iae.0000000000002110

Cited by 62 publications

(59 citation statements)

References 51 publications

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“…A unique feature of the current analysis is that anatomic response to ranibizumab was assessed longitudinally over the first 52 weeks of treatment rather than at a single time point. This is in contrast to previous Early Anti-VEGF Response and Long-term Efficacy programme analyses, which typically assessed anatomic response to ranibizumab at week 12 of treatment (i.e., after the first three monthly intravitreal injections) and failed to demonstrate a significant association between early CRT reduction and longterm BCVA improvement [31]. Similarly, retrospective analyses of the RISE/RIDE study data suggest a dissociation between early anatomic response to ranibizumab after the third monthly intravitreal injection and long-term (2-year) visual acuity outcome in DMO [29].…”

Section: Discussionmentioning

confidence: 68%

“…The Early Anti-VEGF Response and Long-term Efficacy programme, a series of post hoc analyses of data from the Diabetic Retinopathy Clinical Research Network's Protocol I trial [5], one of the largest published studies of ranibizumab in DMO, was initiated to explore the relationship between early and long-term anti-VEGF treatment outcomes. Analyses to date have demonstrated a significant association between early (12-week) and long-term (1-to 3-year) BCVA improvement with ranibizumab [30], but an apparent dissociation between early reduction in macular thickness and long-term BCVA improvement [31]. Given that the use of anti-VEGF treatment in clinical practice is based in large part on optical coherence tomography changes, the present analysis explores the anatomic-functional relationship further by assessing macular thickness over the course of ranibizumab treatment rather than at a single time point.…”

Section: Introductionmentioning

confidence: 99%

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Relationship between duration and extent of oedema and visual acuity outcome with ranibizumab in diabetic macular oedema: A post hoc analysis of Protocol I data

Sadda

Campbell

Dugel

et al. 2019

Eye

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Background/objectives This post hoc analysis explores the relationship between residual oedema exposure after ranibizumab treatment initiation and long-term visual acuity outcome in eyes with centre-involved diabetic macular oedema (DMO). Subjects/methods Eyes randomised to the ranibizumab + prompt or deferred laser treatment arms in the Protocol I trial and with observed central retinal thickness (CRT) readings at baseline and ≥1 follow-up visits (n = 367) were stratified by 1) oedema duration (number of study visits with CRT ≥ 250 µm during the first 52 weeks of ranibizumab treatment); and 2) oedema extent (amount of excess CRT [≥ 250 µm] at each study visit, averaged over the first 52 weeks). Associations between measures of residual oedema and best-corrected visual acuity (BCVA) were assessed in multiple regression analyses. Results Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156. Eyes with the most persistent oedema gained (mean) 4.4 (95% CI 0.1─8.7) fewer Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 156 than eyes with the least persistent oedema (P = 0.044). Eyes with the greatest amount of oedema gained (mean) 9.3 (95% CI 4.0─14.5) fewer ETDRS letters at week 156 than eyes with the least amount of oedema (P < 0.001). Conclusions Macular oedema exposure over the first 52 weeks of ranibizumab treatment is a negative prognostic factor for long-term visual acuity improvement in centre-involved DMO.

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Section: Discussionmentioning

confidence: 68%

Section: Introductionmentioning

confidence: 99%

Relationship between duration and extent of oedema and visual acuity outcome with ranibizumab in diabetic macular oedema: A post hoc analysis of Protocol I data

Sadda

Campbell

Dugel

et al. 2019

Eye

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“…111 In DME patients, post hoc analysis of data from Protocol I of the DRCR Network demonstrated that the initial macular response to three injections of a particular anti-VEGF agent was predictive of long-term outcome. 112 Accordingly, poor responders might potentially benefit from a switch in therapeutic agents.…”

Section: Anti-vegf Therapymentioning

confidence: 99%

<p>The Evolving Treatment of Diabetic Retinopathy</p>

Mansour¹,

Browning²,

Wong³

et al. 2020

OPTH

176

119

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Purpose: To review the current therapeutic options for the management of diabetic retinopathy (DR) and diabetic macular edema (DME) and examine the evidence for integration of laser and pharmacotherapy. Methods: A review of the PubMed database was performed using the search terms diabetic retinopathy, diabetic macular edema, neovascularization, laser photocoagulation, intravitreal injection, vascular endothelial growth factor (VEGF), vitrectomy, pars plana vitreous surgery, antiangiogenic therapy. With additional cross-referencing, this yielded 835 publications of which 301 were selected based on content and relevance. Results: Many recent studies have evaluated the pharmacological, laser and surgical therapeutic strategies for the treatment and prevention of DR and DME. Several newer diagnostic systems such as optical coherence tomography (OCT), microperimetry, and multifocal electroretinography (mfERG) are also assisting in further refinements in the staging and classification of DR and DME. Pharmacological therapies for both DR and DME include both systemic and ocular agents. Systemic agents that promote intensive glycemic control, control of dyslipidemia and antagonists of the renin-angiotensin system demonstrate beneficial effects for both DR and DME. Ocular therapies include anti-VEGF agents, corticosteroids and nonsteroidal anti-inflammatory drugs. Laser therapy, both as panretinal and focal or grid applications continue to be employed in management of DR and DME. Refinements in laser devices have yielded more tissue-sparing (subthreshold) modes in which many of the benefits of conventional continuous wave (CW) lasers can be obtained without the adverse side effects. Recent attempts to lessen the burden of anti-VEGF injections by integrating laser therapy have met with mixed results. Increasingly, vitreoretinal surgical techniques are employed for less advanced stages of DR and DME. The development and use of smaller gauge instrumentation and advanced anesthesia agents have been associated with a trend toward earlier surgical intervention for diabetic retinopathy. Several novel drug delivery strategies are currently being examined with the goal of decreasing the therapeutic burden of monthly intravitreal injections. These fall into one of the five categories: non-biodegradable polymeric drug delivery systems, biodegradable polymeric drug delivery systems, nanoparticle-based drug delivery systems, ocular injection devices and with sustained release refillable devices. At present, there remains no one single strategy for the management of the particular stages of DR and DME as there are many options that have not been rigorously tested through large, randomized, controlled clinical trials. Conclusion: Pharmacotherapy, both ocular and systemic, will be the primary mode of intervention in the management of DR and DME in many cases when cost and treatment burden are less constrained. Conventional laser therapy has become a secondary intervention in these instances, but remains a first-line option when cost and ...

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“…Eine Gruppe von Autoren argumentiert auf Basis der funktionellen oder morphologischen Veränderungen bis Monat 3, dass diese schon zu diesem Zeitpunkt eine Empfehlung im Hinblick auf einen Medikamentenwechsel zulassen könnten [269,270]. Andere Autoren weisen darauf hin, dass gerade solche Patienten trotz des oben erwähnten geringen Visusgewinns bis Monat 3 ("suboptimal response") doch nach 2 Jahren bei konsequenter Fortsetzung des Anti-VEGF-Therapieschemas noch eine relative Visusbesserung oder das Erreichen eines absoluten Visusniveaus (≥ 0,5) zeigten [271].…”

Section: Wiederbehandlungsstrategie Bei Ivom Mit Vegf-inhibitorenunclassified

Stellungnahme der DOG, der RG und des BVA zur Therapie des diabetischen Makulaödems

2020

Klin Monatsbl Augenheilkd

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Association Between Early Anatomic Response to Anti–vascular Endothelial Growth Factor Therapy and Long-Term Outcome in Diabetic Macular Edema

Cited by 62 publications

References 51 publications

Relationship between duration and extent of oedema and visual acuity outcome with ranibizumab in diabetic macular oedema: A post hoc analysis of Protocol I data

Relationship between duration and extent of oedema and visual acuity outcome with ranibizumab in diabetic macular oedema: A post hoc analysis of Protocol I data

<p>The Evolving Treatment of Diabetic Retinopathy</p>

Stellungnahme der DOG, der RG und des BVA zur Therapie des diabetischen Makulaödems

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