Sustained delivery fluocinolone acetonide vitreous implants: Long-term benefit in patients with chronic diabetic macular edema

José Cunha-Vaz, Paul Ashton, Raymond Iezzi, Peter Campochiaro, Pravin U. Dugel, Frank G. Holz, Michel Weber, Ronald P. Danis, Baruch D. Kuppermann, Clare Bailey, Kathleen Billman, Barry Kapik, Frances Kane, Ken Green, P. A. Campochiaro, D. M. Brown, A. Pearson

Research output: Contribution to journalArticle

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Abstract

Participants: Patients with persistent DME despite 1 or more macular laser treatment were randomized 1:2:2 to sham injection (n = 185), FAc 0.2 μg/day (n = 375), or FAc 0.5 μg/day (n = 393).

Methods: Patients received study drug or sham injection and after 6 weeks were eligible for rescue laser. Based on re-treatment criteria, additional masked study drug could be given after 1 year.

Main Outcome Measures: Percentage of patients with improvement of 15 letters or more from baseline. Secondary outcomes included other parameters of visual function and foveal thickness.

Results: At month 36, the difference between FAc 0.2 μg/day and sham control in the percentage of patients who gained 15 letters or more was significantly greater in chronic DME patients (FAc 0.2 μg/day, 34.0% vs. sham, 13.4%; P<0.001), compared with patients with nonchronic DME (FAc 0.2 μg/day, 22.3% vs. sham, 27.8%; P = 0.275). The greater response in patients with chronic DME was not associated with baseline ocular characteristics, changes in anatomic features, or differences in re-treatment or ancillary therapies. The ocular adverse event profile for FAc 0.2 μg/day was similar regardless of DME duration.

Conclusions: This is the first published analysis correlating duration of diagnosis of DME with treatment effect. In patients with chronic DME, FAc 0.2 μg/day provides substantial visual benefit for up to 3 years and would provide an option for patients who do not respond to other therapy.

Purpose: To present the safety and efficacy of intravitreal implants releasing 0.2 μg/day fluocinolone acetonide (FAc) in patients with chronic versus nonchronic diabetic macular edema (DME). To assess ocular characteristics, anatomic changes, and re-treatment and ancillary therapies that may explain the differential treatment effect seen with intravitreal implants releasing FAc 0.2 μg/day in patients with chronic and nonchronic DME. An overall benefitto- risk assessment for the FAc 0.2-μg/day and FAc 0.5-μg/day doses has been reported previously.

Design: Preplanned subgroup analysis of chronic (duration of diagnosis, ≥3 years) and nonchronic (duration of diagnosis, <3 years) DME in patients from 2 randomized, sham injection-controlled, double-masked, multicenter clinical trials.

Original languageEnglish (US)
Pages (from-to)1892-1903
Number of pages12
JournalOphthalmology
Volume121
Issue number10
DOIs
StatePublished - Oct 1 2014

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Fluocinolone Acetonide
Macular Edema
Therapeutics
Injections
Lasers
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Cunha-Vaz, J., Ashton, P., Iezzi, R., Campochiaro, P., Dugel, P. U., Holz, F. G., ... Pearson, A. (2014). Sustained delivery fluocinolone acetonide vitreous implants: Long-term benefit in patients with chronic diabetic macular edema. Ophthalmology, 121(10), 1892-1903. https://doi.org/10.1016/j.ophtha.2014.04.019

Sustained delivery fluocinolone acetonide vitreous implants : Long-term benefit in patients with chronic diabetic macular edema. / Cunha-Vaz, José; Ashton, Paul; Iezzi, Raymond; Campochiaro, Peter; Dugel, Pravin U.; Holz, Frank G.; Weber, Michel; Danis, Ronald P.; Kuppermann, Baruch D.; Bailey, Clare; Billman, Kathleen; Kapik, Barry; Kane, Frances; Green, Ken; Campochiaro, P. A.; Brown, D. M.; Pearson, A.

In: Ophthalmology, Vol. 121, No. 10, 01.10.2014, p. 1892-1903.

Research output: Contribution to journalArticle

Cunha-Vaz, J, Ashton, P, Iezzi, R, Campochiaro, P, Dugel, PU, Holz, FG, Weber, M, Danis, RP, Kuppermann, BD, Bailey, C, Billman, K, Kapik, B, Kane, F, Green, K, Campochiaro, PA, Brown, DM & Pearson, A 2014, 'Sustained delivery fluocinolone acetonide vitreous implants: Long-term benefit in patients with chronic diabetic macular edema', Ophthalmology, vol. 121, no. 10, pp. 1892-1903. https://doi.org/10.1016/j.ophtha.2014.04.019
Cunha-Vaz, José ; Ashton, Paul ; Iezzi, Raymond ; Campochiaro, Peter ; Dugel, Pravin U. ; Holz, Frank G. ; Weber, Michel ; Danis, Ronald P. ; Kuppermann, Baruch D. ; Bailey, Clare ; Billman, Kathleen ; Kapik, Barry ; Kane, Frances ; Green, Ken ; Campochiaro, P. A. ; Brown, D. M. ; Pearson, A. / Sustained delivery fluocinolone acetonide vitreous implants : Long-term benefit in patients with chronic diabetic macular edema. In: Ophthalmology. 2014 ; Vol. 121, No. 10. pp. 1892-1903.
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T1 - Sustained delivery fluocinolone acetonide vitreous implants

T2 - Long-term benefit in patients with chronic diabetic macular edema

AU - Cunha-Vaz, José

AU - Ashton, Paul

AU - Iezzi, Raymond

AU - Campochiaro, Peter

AU - Dugel, Pravin U.

AU - Holz, Frank G.

AU - Weber, Michel

AU - Danis, Ronald P.

AU - Kuppermann, Baruch D.

AU - Bailey, Clare

AU - Billman, Kathleen

AU - Kapik, Barry

AU - Kane, Frances

AU - Green, Ken

AU - Campochiaro, P. A.

AU - Brown, D. M.

AU - Pearson, A.

PY - 2014/10/1

Y1 - 2014/10/1

N2 - Participants: Patients with persistent DME despite 1 or more macular laser treatment were randomized 1:2:2 to sham injection (n = 185), FAc 0.2 μg/day (n = 375), or FAc 0.5 μg/day (n = 393).Methods: Patients received study drug or sham injection and after 6 weeks were eligible for rescue laser. Based on re-treatment criteria, additional masked study drug could be given after 1 year.Main Outcome Measures: Percentage of patients with improvement of 15 letters or more from baseline. Secondary outcomes included other parameters of visual function and foveal thickness.Results: At month 36, the difference between FAc 0.2 μg/day and sham control in the percentage of patients who gained 15 letters or more was significantly greater in chronic DME patients (FAc 0.2 μg/day, 34.0% vs. sham, 13.4%; P<0.001), compared with patients with nonchronic DME (FAc 0.2 μg/day, 22.3% vs. sham, 27.8%; P = 0.275). The greater response in patients with chronic DME was not associated with baseline ocular characteristics, changes in anatomic features, or differences in re-treatment or ancillary therapies. The ocular adverse event profile for FAc 0.2 μg/day was similar regardless of DME duration.Conclusions: This is the first published analysis correlating duration of diagnosis of DME with treatment effect. In patients with chronic DME, FAc 0.2 μg/day provides substantial visual benefit for up to 3 years and would provide an option for patients who do not respond to other therapy.Purpose: To present the safety and efficacy of intravitreal implants releasing 0.2 μg/day fluocinolone acetonide (FAc) in patients with chronic versus nonchronic diabetic macular edema (DME). To assess ocular characteristics, anatomic changes, and re-treatment and ancillary therapies that may explain the differential treatment effect seen with intravitreal implants releasing FAc 0.2 μg/day in patients with chronic and nonchronic DME. An overall benefitto- risk assessment for the FAc 0.2-μg/day and FAc 0.5-μg/day doses has been reported previously.Design: Preplanned subgroup analysis of chronic (duration of diagnosis, ≥3 years) and nonchronic (duration of diagnosis, <3 years) DME in patients from 2 randomized, sham injection-controlled, double-masked, multicenter clinical trials.

AB - Participants: Patients with persistent DME despite 1 or more macular laser treatment were randomized 1:2:2 to sham injection (n = 185), FAc 0.2 μg/day (n = 375), or FAc 0.5 μg/day (n = 393).Methods: Patients received study drug or sham injection and after 6 weeks were eligible for rescue laser. Based on re-treatment criteria, additional masked study drug could be given after 1 year.Main Outcome Measures: Percentage of patients with improvement of 15 letters or more from baseline. Secondary outcomes included other parameters of visual function and foveal thickness.Results: At month 36, the difference between FAc 0.2 μg/day and sham control in the percentage of patients who gained 15 letters or more was significantly greater in chronic DME patients (FAc 0.2 μg/day, 34.0% vs. sham, 13.4%; P<0.001), compared with patients with nonchronic DME (FAc 0.2 μg/day, 22.3% vs. sham, 27.8%; P = 0.275). The greater response in patients with chronic DME was not associated with baseline ocular characteristics, changes in anatomic features, or differences in re-treatment or ancillary therapies. The ocular adverse event profile for FAc 0.2 μg/day was similar regardless of DME duration.Conclusions: This is the first published analysis correlating duration of diagnosis of DME with treatment effect. In patients with chronic DME, FAc 0.2 μg/day provides substantial visual benefit for up to 3 years and would provide an option for patients who do not respond to other therapy.Purpose: To present the safety and efficacy of intravitreal implants releasing 0.2 μg/day fluocinolone acetonide (FAc) in patients with chronic versus nonchronic diabetic macular edema (DME). To assess ocular characteristics, anatomic changes, and re-treatment and ancillary therapies that may explain the differential treatment effect seen with intravitreal implants releasing FAc 0.2 μg/day in patients with chronic and nonchronic DME. An overall benefitto- risk assessment for the FAc 0.2-μg/day and FAc 0.5-μg/day doses has been reported previously.Design: Preplanned subgroup analysis of chronic (duration of diagnosis, ≥3 years) and nonchronic (duration of diagnosis, <3 years) DME in patients from 2 randomized, sham injection-controlled, double-masked, multicenter clinical trials.

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