A Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND)

Ophthalmic Research

Volumn 57, Issue 3, 2017, Pages 166-172

  Figueira, João ^a,b,c   Henriques, José ^d   Amaro, Miguel ^e   Rosas, Vítor ^f   Alves, Dalila ^a   Cunha Vaz, José ^a,b  

^a ASSOCIATION FOR INNOVATION AND BIOMEDICAL RESEARCH ON LIGHT AND IMAGE AIBILI   (Portugal)

^b UNIVERSITY OF COIMBRA   (Portugal)

^c CENTRO HOSPITALAR E UNIVERSITÁRIO DE COIMBRA   (Portugal)

^d Instituto Retina de Lisboa (IRL)   (Portugal)

^e Vila Franca de Xira Hospital and Internal Medicine Department of the CUF Torres Vedras Hospital   (Portugal)

^f HOSPITAL DE SÃO JOÃO   (Portugal)

Author keywords

Central subfield thickness; Diabetes; Intravitreal implant; Macular edema; Visual acuity

Indexed keywords

EYE DROPS; FLUOCINOLONE ACETONIDE; STEROID; VASCULOTROPIN ANTIBODY; ANGIOGENESIS INHIBITOR; DELAYED RELEASE FORMULATION; DRUG IMPLANT;

ADULT; ANAMNESIS; ARTICLE; CHRONIC DISEASE; CLINICAL ARTICLE; DEMOGRAPHY; DIABETIC MACULAR EDEMA; DRUG DELIVERY SYSTEM; DRUG EFFECT; DRUG IMPLANT; DRUG SAFETY; FEMALE; FOLLOW UP; HUMAN; INTRAOCULAR PRESSURE ABNORMALITY; LABORATORY TEST; MALE; MULTICENTER STUDY; OPEN STUDY; OUTCOME ASSESSMENT; PHASE 4 CLINICAL TRIAL; PILOT STUDY; PROSPECTIVE STUDY; PSEUDOPHAKIA; SPECTRAL DOMAIN OPTICAL COHERENCE TOMOGRAPHY; TREATMENT DURATION; TREATMENT RESPONSE; VISUAL ACUITY; VISUAL SYSTEM EXAMINATION; ADMINISTRATION AND DOSAGE; AGED; CLINICAL TRIAL; DELAYED RELEASE FORMULATION; DIABETIC RETINOPATHY; INTRAVITREAL DRUG ADMINISTRATION; MACULAR EDEMA; MIDDLE AGED; PATHOPHYSIOLOGY;

AGED; ANGIOGENESIS INHIBITORS; CHRONIC DISEASE; DELAYED-ACTION PREPARATIONS; DIABETIC RETINOPATHY; DRUG IMPLANTS; FEMALE; FLUOCINOLONE ACETONIDE; HUMANS; INTRAVITREAL INJECTIONS; MACULAR EDEMA; MALE; MIDDLE AGED; PILOT PROJECTS; PROSPECTIVE STUDIES; VISUAL ACUITY;

EID: 85011842236     PISSN: 00303747     EISSN: 14230259     Source Type: Journal    
DOI: 10.1159/000455235     Document Type: Article

References (21)

1. Guariguata L, Whiting DR, Hambleton I, et al: Global estimates of diabetes prevalence for 2013 and projections for 2035. Diabetes Res Clin Pract 2014; 103: 137-149.
2. International Diabetes Federation: IDF Diabetes Atlas, ed 7. Brussels, IDF, 2015.
3. Yau JW, Rogers SL, Kawasaki R, et al: Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care 2012; 35: 556-564.
4. Zhang X, Zeng H, Bao S, et al: Diabetic macular edema: new concepts in patho-physiology and treatment. Cell Biosci 2014; 4: 27.
5. Bhagat N, Grigorian RA, Tutela A, Zarbin MA: Diabetic macular edema: pathogenesis and treatment. Surv Ophthalmol 2009; 54: 1-32.
6. Augustin AJ, et al: Management of diabetic macular oedema-challenges and solutions along the patient journey. Eur Ophthal Rev 2013; 7: 115-120.
7. Elman MJ, Aiello LP, Beck RW, et al: Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology 2010; 117: 1064-1077.e35.
8. Wells JA, Glassman AR, Ayala AR, et al: Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med 2015; 372: 1193-1203.
9. Callanan DG, Gupta S, Boyer DS, et al: Dexamethasone intravitreal implant in combination with laser photocoagulation for the treatment of diffuse diabetic macular edema. Ophthalmology 2013; 120: 1843-1851.
10. Kane FE, Burdan J, Cutino A, et al: ILUVIEN: a new sustained delivery technology for posterior eye disease. Expert Opin Drug Deliv 2008; 5: 1039-1046.
11. Infarmed: Relatorio de Avaliacao Previa do Medicamento para Uso Humano em Meio Hospitalar ILUVIEN ®. http://www. infarmed.pt/portal/page/portal/Infarmed/ Medicamentos-uso-Humano/Avaliacao- Economica-e-Comparticipacao/Medicamentos- uso-Hospital/DL-N-195-2006-3- OUT/Relatorios-Avaliacao-Previa/PDF/Parecer% 20net-ILUVIEN.pdf (accessed July 7, 2016).
12. Campochiaro PA, Nguyen QD, Hafiz G, et al: Aqueous levels of fluocinolone acetonide after administration of fluocinolone acetonide inserts or fluocinolone acetonide implants. Ophthalmology 2013; 120: 583-587.
13. Campochiaro PA, Brown DM, Pearson A, et al: Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Ophthalmology 2012; 119: 2125-2132.
14. Infarmed: ILUVIEN ®-summary of product characteristics. http://www.infarmed.pt/ infomed/download-ficheiro.php?med- id=52065&tipo-doc=rcm (accessed July 7, 2016).
15. Wykoff CC, Chakravarthy U, Campochiaro PA, Bailey C, Green K, Cunha-Vaz J: Longterm effects of intravitreal 0.2 mg fluocinolone acetonide implant on progression and regression of diabetic retinopathy. Ophthalmology, in press.
16. Henriques J, Figueira J, Nascimento J, et al: Retinopatia diabetica-orientacoes clinicas do Grupo de Estudos da Retina de Portugal. Oftalmol Soc Port Oftalmol 2015; 39(suppl):4.
17. Massin P, Erginay A, Dupas B, Couturier A, Tadayoni R: Efficacy and safety of sustaineddelivery fluocinolone acetonide intravitreal implant in patients with chronic diabetic macular edema insufficiently responsive to available therapies: a real-life study. Clin Ophthalmol 2016; 10: 1257-1264.
18. Yang Y, Bailey C, Holz FG, et al: Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants. Eye (London) 2015; 29: 1240.
19. Goncalves R, Teixeira C, Carvalho R, et al: Real life experience with intravitreal 0.2 μg/ day fluocinolone acetonide (FAc) implant (ILUVIEN ® ) in the treatment of patients with diabetic macular oedema (DME) insufficiently responsive to previous therapies. Presented at the 16th EURETINA Congress, Copenhagen, 2016.
20. Meireles A, Coelho J, Pessoa B: A retrospective evaluation of the efficacy and safety of fluocinolone acetonide 0.2 μg/day implant in patients with chronic diabetic macular edema with insufficient response to other therapies. Invest Ophthalmol Vis Sci 2016;57:3273-3273.
21. Coelho J, Pessoa B, Dias D, et al: Efficacy results of 0.2 μg/day fluocinolone acetonide (FAc) implant in vitrectomized eyes with diabetic macular edema. Presented at the 16th EURETINA Congress, Copenhagen, 2016.