Visual Acuity Outcomes in Diabetic Macular Edema With Fluocinolone Acetonide 0.2 μg/Day Versus Ranibizumab Plus Deferred Laser (DRCR Protocol I)

Singer, Michael; Miller, Dan M.; Gross, Jeffrey G.; Greven, Craig M.; Kapik, Barry; Bailey, Clare; Ghanchi, Faruque; Kuppermann, Baruch D.

doi:10.3928/23258160-20180831-08

Cited by 9 publications

(8 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Several clinical trials demonstrated high safety and efficacy of ranibizumab in the management of DME, exploring the usage of ranibizumab in different modalities and concentrations, as well as alone or in combination with laser, including READ-2 [ 77 ], RESOLVE [ 78 ], RESTORE [ 79 ], RISE and RIDE [ 80 ], LUCIDATE [ 81 ], REVEAL [ 82 ], RELIGHT [ 83 ], RETAIN [ 84 ] and READ-3 [ 85 ]. DRCR network conducted several multicenter clinical trials analyse similarities and differences of ranibizumab, with respect to other approaches, including other anti-VEGF molecules, corticosteroids, or laser, in the management of DR: Protocol S (ranibizumab vs. laser in PDR) [ 86 , 87 ], Protocol T (ranibizumab vs. aflibercept vs. bevacizumab in DME) [ 88 ] and Protocol I (fluocinolone acetonide vs. ranibizumab plus deferred laser in DME) [ 89 ] studies. Other meaningful clinical trials involving ranibizumab were: TREX-DME (ranibizumab “treat and extend” regimen with or without laser in DME) [ 90–92 ], ROTATE (ranibizumab in persistent DME after bevacizumab treatment) [ 93 ], RELATION (ranibizumab plus laser vs. laser alone in DR) [ 94 ] and REFINE (ranibizumab vs. laser in DME) [ 95 ] studies.…”

Section: Anti-vascular Endothelial Growth Factor Moleculesmentioning

confidence: 99%

VEGF-targeting drugs for the treatment of retinal neovascularization in diabetic retinopathy

2022

View full text Add to dashboard Cite

Diabetic retinopathy (DR) is the most common microangiopathic complication of diabetes mellitus, representing a major cause of visual impairment in developed countries. Proliferative DR (PDR) represents the last stage of this extremely complex retinal disease, characterized by the development of neovascularization induced by the abnormal production and release of vascular endothelial growth factor (VEGF). The term VEGF includes different isoforms; VEGF-A represents one of the most important pathogenic factors of DR. Anti-VEGF intravitreal therapies radically changed the outcome of DR, due to combined anti-angiogenic and anti-edematous activities. Nowadays, several anti-VEGF molecules exist, characterized by different pharmacological features and duration. With respect to PDR, although anti-VEGF treatments represented a fundamental step forward in the management of this dramatic complication, a big debate is present in the literature regarding the role of anti-VEGF as substitute of panretinal photocoagulation or if these two approaches may be used in combination. In the present review, we provided an update on VEGF isoforms and their role in DR pathogenesis, on current anti-VEGF molecules and emerging new drugs, and on the current management strategies of PDR. There is an overall agreement regarding the relative advantage provided by anti-VEGF, especially looking at the management of PDR patients requiring vitrectomy, with respect to laser. Based on the current data, laser approaches might be avoided when a perfectly planned anti-VEGF therapeutic strategy can be adopted. Conversely, laser treatment may have a role for those patients unable to guarantee enough compliance to anti-VEGF injections. Key messages VEGF increased production, stimulated by retinal hypoperfusion and ischaemia, is a major pathogenic factor of neovascular complication onset in diabetic retinopathy and of DR stages progression. Nowadays, several anti-VEGF molecules are available in clinical practice and other molecules are currently under investigation. Each anti-VEGF molecule is characterized by different targets and may interact with multiple biochemical pathways within the eye. All the data agreed in considering anti-VEGF molecules as a first line choice for the management of diabetic retinopathy. Laser treatments may have a role in selected advanced cases and for those patients unable to guarantee enough compliance to intravitreal treatments schemes.

show abstract

Section: Anti-vascular Endothelial Growth Factor Moleculesmentioning

confidence: 99%

VEGF-targeting drugs for the treatment of retinal neovascularization in diabetic retinopathy

2022

View full text Add to dashboard Cite

show abstract

“…The calculation of AUC has been described previously. 17,18 AUC was based on BCVA as this was the primary outcome in both FAME 16 and MEAD trials. 3 AUC for MEAD and FAME trials were based on BCVA letter score from baseline through to final visit (36 months in the FAME trial and 39 months in the MEAD trial).…”

Section: Auc Calculationmentioning

confidence: 99%

“…Mean AUC was then calculated using individual patient AUC values. 18 AUC for DEX was obtained from published data. [12][13][14] In the FAME trial, the observed change in BCVA letter score from baseline through to Month 36 was used to calculate AUC using the trapezoidal rule.…”

Section: Auc Calculationmentioning

confidence: 99%

“…17 For each subject, the summarized variable represented total AUC divided by the total number of days in the study. 18…”

Section: Auc Calculationmentioning

confidence: 99%

“…16 AUC calculations for BCVA did not form part of the analysis plan in the FAME trial, even though the AUC analysis 17 provides a more holistic clinical comparison than single time-point measurements and has previously been used to evaluate the effect of longer duration drugs. 18 The AUC method may provide a better means of comparing outcomes between studies than other efficacy measures, 19 and the objective of the current study was to assess AUC outcomes in the FAME trial and to indirectly compare these with the outcomes achieved in the MEAD trial.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

<p>Effectiveness of 190 μg Fluocinolone Acetonide and 700 μg Dexamethasone Intravitreal Implants in Diabetic Macular Edema Using the Area-Under-the-Curve Method: The CONSTANT Analysis</p>

Zarranz‐Ventura¹,

Mali²

2020

OPTH

View full text Add to dashboard Cite

Purpose: Calculations of area-under-the-curve (AUC) provide the average letters gained across the entire treatment period, which may be a better estimate of long-term effectiveness than single time-point outcomes, particularly when it comes to sustained-release therapies. Materials and Methods: The AUC method was used to compare the efficacy of the 0.2 µg/day fluocinolone acetonide (total dose of 0.19 mg; FAc) and dexamethasone (DEX) 700 µg implants based on published data from their respective Phase 3 FAME (Fluocinolone Acetonide for Macular Edema) and MEAD pivotal clinical trials in diabetic macular edema (DME). Best-corrected visual acuity (BCVA) letter scores were collated from the FAME trial and compared with those reported in MEAD. The trapezoidal rule was then used to calculate AUC, based on BCVA letter score, from baseline to Month 36 (FAME)/Month 39 (MEAD) and presented as an overall mean visual acuity change per day. Results: Treatment with either the FAc or DEX implant resulted in an improved BCVA over the treatment period compared with sham. This effect was statistically greater (p=0.029) for the FAc implant than the DEX implant (5.2 vs 3.5 letters/day, respectively) and even greater in the recurrent DME subgroup (p<0.001; 6.9 vs 3.5 letters/day, respectively). Conclusion: Although direct comparisons between trial cohorts cannot be performed, this analysis indicated that, in their respective pivotal clinical trial cohorts, treatment with the FAc implant provides better long-term visual acuity outcomes and a lower treatment burden than achieved with the DEX implant.

show abstract

Diabetic Retinopathy

Abazari

Ghazi

Karcioglu

2022

Diabetes and Kidney Disease

View full text Add to dashboard Cite

Visual Acuity Outcomes in Diabetic Macular Edema With Fluocinolone Acetonide 0.2 μg/Day Versus Ranibizumab Plus Deferred Laser (DRCR Protocol I)

Abstract: In pseudophakic and chronic DME subgroups, FAc was comparable to ranibizumab plus deferred laser with fewer injections. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:698-706.].

Cited by 9 publications

References 14 publications

VEGF-targeting drugs for the treatment of retinal neovascularization in diabetic retinopathy

VEGF-targeting drugs for the treatment of retinal neovascularization in diabetic retinopathy

<p>Effectiveness of 190 μg Fluocinolone Acetonide and 700 μg Dexamethasone Intravitreal Implants in Diabetic Macular Edema Using the Area-Under-the-Curve Method: The CONSTANT Analysis</p>

Diabetic Retinopathy

Contact Info

Product

Resources

About