September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Preliminary results from the RESPOND trial: Investigator-driven study in Portugal to evaluate real-life safety and efficacy of ILUVIEN in patients with chronic DME.
Author Affiliations & Notes
  • Joao Figueira
    CEC, AIBILI, Coimbra, Portugal
    Ophthalmology Department, Coimbra University Hospital, Coimbra, Portugal
  • Miguel Amaro
    Ophthalmology Department, Hospital Vila Franca de Xira, Vila Franca de Xira, Portugal
  • José Henriques
    Instituto de Retina e Diabetes Ocular de Lisboa, Lisboa, Portugal
  • Vitor Rosas
    Ophthalmology Department, Centro Hospitalar de São João, Porto, Portugal
  • Footnotes
    Commercial Relationships   Joao Figueira, Alimera (C); Miguel Amaro, None; José Henriques, None; Vitor Rosas, None
  • Footnotes
    Support  Alimera Sciences Grant
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 3257. doi:
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      Joao Figueira, Miguel Amaro, José Henriques, Vitor Rosas; Preliminary results from the RESPOND trial: Investigator-driven study in Portugal to evaluate real-life safety and efficacy of ILUVIEN in patients with chronic DME.. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3257.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To evaluate real-life safety and efficacy of ILUVIEN in chronic diabetic macular edema (DME) patients judged insufficiently responsive to other available therapies by ophthalmologists in Portugal.

Methods : Twelve patients diagnosed with chronic DME (> 1 year) that did not respond sufficiently to previous treatments (laser and/or anti-VEGF with or without corticosteroids) were selected to receive an intravitreal injection of fluocinolone acetonide (ILUVIEN).
After ILUVIEN administration, patients are to be followed for 1 year, performing visits at 1 week, and at months 1, 3, 6, 9 and 12. Parameters measured include: best-corrected visual acuity (BCVA) change from baseline; and changes in macular thickness and volume from baseline. The occurrence of increased intraocular pressure (IOP) and other safety issues is recorded. The study started in October 2014 and results are reported here after 6 months with subsequent data available imminently.

Results : Twelve patients were included (8 males) with a mean age of 69.6±9.3 years. Eight eyes were pseudophakic and 4 were phakic (all these eyes already had cataract at baseline and planned surgery). One phakic patient had cataract worsening and already had surgery, improving BCVA after it. The mean duration of DME was 3.4±3.1 years.
Mean prior therapies per patient were: 4.4±4.2 [1 to 14] laser treatments; 4.0±2.9 [1 to 9] anti-VEGF injections; and 2.0±1.4 [1 to 4] intravitreal corticosteroids.
Mean BCVA increased by 6.8±12.3 [-14 to 22 ETDRS letters] from baseline. Based on a response of ±3 ETDRS letters: 3 patients maintained their BCVA; 7 patients improved; and 2 patient worsened due to the presence of a cataract.
Central subfield thickness and macular volume decreased by -291.1±212.9 μm [-568.0 to 129.0] and -1.7±1.9 mm3 [-4.53 to 2.52] from baseline, respectively.
Of the 12 eyes included, 9 did not show a significant increase in IOP. The 3 patients who presented an IOP >22 mmHg were well controlled with eye drops.

Conclusions : Preliminary results showed that all eyes with chronic DME not responding to prior therapies had improvements in BCVA (+6.8), macular thickness (-291.1 μm) and volume (-1.7 mm3) after ILUVIEN injection. ILUVIEN was well tolerated and only 25% of patients had a rise in IOP over 22 mmHg, well managed with eye drops. At ARVO meeting 1 year data will be reported.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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