scholarly journals Effect of fluocinolone acetonide 0.2 μg/day implant on the decision to drive in patients with diabetic macular oedema: a report from the FAME study

2019 ◽  
Vol 4 (1) ◽  
pp. e000405 ◽  
Author(s):  
Dilraj S Grewal ◽  
Donald C Fletcher ◽  
Seenu M Hariprasad ◽  
Ivan J Suner
Keyword(s):  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Fluocinolone Acetonide ◽  
Phase Iii ◽  
Full Cohort ◽  
Post Hoc Analysis ◽  
Corrected Visual Acuity ◽  
Central Subfield Thickness ◽  
Post Hoc

ObjectiveThis study aimed to determine whether treatment with the 0.2 µg/day fluocinolone acetone implant (FAc; ILUVIEN, Alimera Sciences) and the associated improvements in best-corrected visual acuity (BCVA) and central subfield thickness (CST) demonstrated in the Fluocinolone Acetonide in Diabetic Macular Edema (FAME) study have an impact on the patient’s decision to drive as measured by the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25).MethodsThis was a post hoc analysis of up to 3 years of NEI-VFQ-25 data collected during the phase III FAME trial. Patients were divided into four quartiles according to baseline NEI-VFQ-25 driving subscale (DSS) score. Patients who had never driven were excluded. Patients received either the 0.2 µg/day FAc implant or sham (dummy injection). Change in the DSS score of the NEI-VFQ-25 questionnaire over 3 years in FAc-treated versus sham-treated patients was analysed by BCVA, CST and baseline DSS score.ResultsThe proportion of patients achieving BCVA≥20/40 was similar between the FAc and sham groups throughout the study, while improvements in CST were significantly greater in the quartile of FAc-treated patients with the lowest baseline DSS score (quartile 1; p=0.04). Significant improvements in DSS score were also observed in quartile 1 (p=0.024), while numerical—but not significant—improvements in DSS score were observed in the full cohort.ConclusionThis post hoc analysis demonstrates a significant association between clinical outcomes in diabetic macular oedema and improvement in quality of life measures following a single FAc implant.

Post hoc analysis of a phase III study to test the association between circulating methylated glutathione s transferase (mGSTP1) DNA levels and response to docetaxel (DTX) in metastatic castration resistant prostate cancer (mCRPC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5014-5014
Author(s):  
Kate Lynette Mahon ◽  
Wenjia Qu ◽  
Hui-Ming Lin ◽  
Calan Spielman ◽  
Daniel Cain ◽  
...  
Keyword(s):  
Cpg Island ◽  
Multivariable Analysis ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Serum Samples ◽  
Full Cohort ◽  
Post Hoc Analysis ◽  
Time Points ◽  
Phase Iii Study ◽  
Post Hoc

5014 Background: GSTP1 inactivation is associated with CpG island hypermethylation in > 99% prostate cancers. Detection of circulating mGSTP1 DNA predicts response to DTX and overall survival (OS) in phase I/II mCRPC cohorts. This post hoc analysis of a phase III study aims to test the association between circulating mGSTP1 DNA levels and outcomes. Methods: The phase III SYNERGY study tested DTX +/- custirsen as 1st line chemotherapy in mCRPC (n = 1022) with no OS benefit in the experimental arm. Serum samples were taken at baseline (BL) and preC3 of DTX +/- custirsen from 600 patients (pts) enrolled on the SYNERGY study. mGSTP1levels in free DNA were measured using a sensitive methylation specific PCR assay and correlated with PSA response, time to PSA progression (TTP) and OS. Results: On interim analysis of 300 pts, serum mGSTP1 was detectable at BL in 80% and preC3 in 44%. Undetectable preC3 mGSTP1 correlated with a ≥30% fall in PSA within 3m of starting DTX (p < 0.001). Detectable BL and preC3 mGSTP1 predicted shorter TTP after DTX (BL; HR 1.6 95%CI 1.1-2.3; p = 0.01 and preC3 HR 2.2 95%CI 1.6-2.9; p < 0.001). Detectable mGSTP1 at both time points predicted shorter OS (BL; median OS 18.4 vs 33.1m, HR 2.4 95%CI 1.6-3.7; p < 0.001 and preC3; median OS 13.9 vs 29m, HR 2.7 95%CI 2.0-3.6; p < 0.001). In those with detectable BL mGSTP1, 50% had undetectable preC3 mGSTP1 predicting > 30% fall in PSA within 3m (p < 0.001), improved TTP (HR 0.40 95%CI 0.29-0.57; p < 0.001) and improved OS (25.2 vs 13.9 m HR 0.38 95%CI 0.28-0.51; p < 0.001). On multivariable analysis including Hb, Karnofsky PS, LDH, PSA and visceral metastases, detectable preC3 mGSTP1 independently predicted shorter TTP (HR 1.9 95%CI 1.4-2.6; p < 0.001). Detectable mGSTP1at both time points independently predicted OS (BL; HR1.8 95%CI 1.2-2.8; p = 0.006 and preC3; HR 2.2 95%CI 1.6-3.0; p < 0.001). Results from the full cohort of 600 pts will be available for presentation at the meeting. Conclusions: This study should validate circulating mGSTP1 DNA as a marker of therapeutic benefit and prognosis in men with mCRPC receiving DTX and could be utilized for clinical management.

scholarly journals Quality of life and functional outcomes with tapentadol prolonged release in chronic musculoskeletal pain: post hoc analysis

2020 ◽  
Author(s):  
Cesar Margarit Ferri ◽  
Silvia Natoli ◽  
Paz Sanz-Ayan ◽  
Alberto Magni ◽  
Carlos Guerrero ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Pain ◽  
Phase Iii ◽  
Prolonged Release ◽  
Post Hoc Analysis ◽  
Three Phase ◽  
Sf 36 ◽  
Phase Iii Trials ◽  
Post Hoc

Aims: To investigate quality of life (QOL) and functionality changes in chronic pain during tapentadol prolonged release (PR) treatment. Patients & methods: Post hoc analysis of data from three Phase III trials in patients with osteoarthritis knee pain or low back pain. QOL and functionality changes were assessed by SF-36 scores. Results: All SF-36 subdomain scores improved progressively to week 3 of tapentadol titration and were sustained during 12-week maintenance treatment. Improvements in SF-36 scores were similar between tapentadol dose groups (e.g., 200 to <300 mg vs ≥500 mg), with no greater effect from higher doses. QOL and functionality improvements were consistently greater with tapentadol PR than oxycodone controlled release. Conclusion: Tapentadol PR provides consistent, clinically relevant improvements in QOL and functionality in chronic pain.

scholarly journals 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

Eye ◽  
2019 ◽  
Vol 34 (3) ◽  
pp. 480-490 ◽  
Author(s):  
Srinivas R. Sadda ◽  
Joanna Campbell ◽  
Pravin U. Dugel ◽  
Nancy M. Holekamp ◽  
Szilárd Kiss ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Post Hoc Analysis ◽  
Post Hoc

scholarly journals Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Analysis of Quality of Life during a Phase III Study

2021 ◽  
pp. 1-8
Author(s):  
Alexander V. Karaulov ◽  
Natalia Nenasheva ◽  
Yury Smolkin ◽  
Aleksandr Maslakov ◽  
Luiz Lucio
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Triamcinolone Acetonide ◽  
Allergic Conjunctivitis ◽  
Phase Iii ◽  
Treatment Groups ◽  
Post Hoc Analysis ◽  
Previous Diagnosis ◽  
Post Hoc

<b><i>Introduction:</i></b> Allergic rhinitis (AR) is a disease that affects ≤24% of people in Russia, significantly impairing quality of life (QoL). Intranasal corticosteroids, such as triamcinolone acetonide (TAA), are considered effective drugs for treatment. A post hoc analysis of data (phase III NASANIF trial) examined weekly QoL changes in patients receiving TAA for the treatment of perennial AR (PAR). <b><i>Methods:</i></b> NASANIF (NCT03317015) was a double-blind, parallel group, multicenter, prospective, noninferiority, phase III clinical trial. Patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) for 4 weeks. Here, a post hoc analysis measures QoL using a shortened Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ). Differences in miniRQLQ score were evaluated using a mixed linear model and descriptive statistics. A subgroup analysis was performed in patients with a previous diagnosis of allergic conjunctivitis. <b><i>Results:</i></b> Of 260 patients eligible for randomization, 128 each completed treatment with TAA or FP. Overall and individual domain scores progressively improved and were significantly different versus baseline at week 4 in both treatment groups: LS mean difference TAA: −30.92 (95% CI [−33.01 to −28.83]), <i>p</i> &#x3c; 0.001, and FP: −31.13 (−33.23 to −29.04), <i>p</i> &#x3c; 0.001. In both arms of the subgroup, there was a significant reduction in eye symptoms. There was no significant difference between the TAA and FP treatment groups in any analyses. <b><i>Conclusions:</i></b> TAA is effective in improving overall and individual domains of QoL in patients with PAR, over 4 weeks. Patients with a previous diagnosis of allergic conjunctivitis experienced significant improvements in QoL related to the resolution of these symptoms.

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

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.

scholarly journals Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants

Eye ◽  
2015 ◽  
Vol 29 (9) ◽  
pp. 1173-1180 ◽  
Author(s):  
Y Yang ◽  
◽  
C Bailey ◽  
F G Holz ◽  
N Eter ◽  
...  
Keyword(s):  
Cataract Surgery ◽  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Cataract Extraction ◽  
Fluocinolone Acetonide ◽  
Long Term Outcomes ◽  
Phase 3 ◽  
Corrected Visual Acuity ◽  
Working Age

Abstract Purpose Diabetic macular oedema (DMO) is a leading cause of blindness in working-age adults. Slow-release, nonbioerodible fluocinolone acetonide (FAc) implants have shown efficacy in the treatment of DMO; however, the National Institute for Health and Care Excellence recommends that FAc should be used in patients with chronic DMO considered insufficiently responsive to other available therapies only if the eye to be treated is pseudophakic. The goal of this analysis was to examine treatment outcomes in phakic patients who received 0.2 μg/day FAc implant. Methods This analysis of the phase 3 FAME (Fluocinolone Acetonide in Diabetic Macular Edema) data examines the safety and efficacy of FAc implants in patients who underwent cataract extraction before (cataract before implant (CBI) group) or after (cataract after implant (CAI) group) receiving the implant. The data were further examined by DMO duration. Results Best corrected visual acuity (BCVA) after 36 months was comparable in the CAI and CBI groups. Both the percentage of patients gaining ≥3 lines of vision and mean change in BCVA letter score were numerically greater in the CAI group. In addition, most patients who underwent cataract surgery experienced a net gain in BCVA from presurgery baseline as well as from original study baseline. Conclusions These data support the use of 0.2 μg/day FAc implants in phakic as well as in pseudophakic patients. These findings will serve as a pilot for design of future studies to evaluate the potential protective effect of FAc implants before cataract surgery in patients with DMO and cataract.

scholarly journals Two-year interim safety results of the 0.2 µg/day fluocinolone acetonide intravitreal implant for the treatment of diabetic macular oedema: the observational PALADIN study

2020 ◽  
pp. bjophthalmol-2020-315984
Author(s):  
Sam E Mansour ◽  
Daniel F Kiernan ◽  
Daniel B Roth ◽  
David Eichenbaum ◽  
Nancy M Holekamp ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Oedema ◽  
Prospective Observational Study ◽  
Diabetic Macular Oedema ◽  
Fluocinolone Acetonide ◽  
Central Subfield Thickness ◽  
Intravitreal Implant ◽  
Registration Number ◽  
Fluocinolone Acetonide Intravitreal Implant

BackgroundThe 0.2 µg/day fluocinolone acetonide (FAc) implant delivers continuous, low-dose, intravitreal corticosteroid for the treatment of diabetic macular oedema (DMO). This ongoing, 3-year, observational clinical trial provides long-term, ‘real-world’ safety results for the FAc implant in DMO.MethodsThis 24-month interim analysis of a prospective, observational study investigated patients with DMO receiving the commercially available intravitreal 0.2 µg/day FAc implant. The primary outcome was incidence of intraocular pressure (IOP)-lowering procedures. Other IOP-related signals and their relationship to previous corticosteroid exposure, best-corrected visual acuity, central subfield thickness (CST), ocular adverse events and frequency of other treatments were also measured.ResultsData were collected from 95 previously steroid-challenged patients (115 study eyes) for up to 36 months pre-FAc and 24 months post-FAc implant. Mean IOP for the overall population remained stable post-FAc compared with pre-FAc implant. IOP-related procedures remained infrequent (two IOP-lowering surgeries pre-FAc; two trabeculoplasties and four IOP-lowering surgeries post-FAc). Mean visual acuity was stable post-FAc (mean improvement of 1–3 letters) and fewer DMO treatments were required per year following FAc implant. Mean CST was significantly reduced at 24 months post-FAc implant (p<0.001) and the percentage of patients with CST ≤300 µm was significantly increased (p=0.041).ConclusionFew IOP-related procedures were reported during the 24 months post-FAc implant. Positive efficacy outcomes were noted after treatment, with stabilisation of vision and reduction in inflammation, demonstrated by CST. The FAc implant has a favourable benefit–risk profile in the management of DMO, especially when administered after a prior steroid challenge.Trial registration numberNCT02424019.

Sign in / Sign up

Export Citation Format

Share Document