One year results of a phase 1 study of the safety and tolerability of combination therapy using sustained release intravitreal triamcinolone acetonide and ranibizumab for subfoveal neovascular AMD.
OBJECTIVE
To investigate safety and evidence of efficacy of IBI-20089, an intravitreal, liquid, sustained drug delivery system formulated with triamcinolone acetonide (TA) in combination with ranibizumab (Lucentis) for neovascular age related macular degeneration.


METHODS
Patients received a single intravitreal injection of IBI-20089 containing either 6.9 mg (25 µL) TA or 13.8 mg (50 µL) TA followed a week later by intravitreal injection of 0.5 mg ranibizumab. Patients were followed monthly and underwent best corrected visual acuity testing, slit lamp biomicroscopy, dilated ophthalmoscopy, fundus photos and optical coherence tomography. Patients received pro re nata dosing of ranibizumab.


RESULTS
Patients ranged in age from 59 years to 81 years (mean 73.4 years) and all completed 1 year follow-up. No serious related adverse events occurred. Ocular adverse events included mild, transient, elevated intraocular pressure in eight patients and cataract progression in three of the five phakic patients. At 1 year, 30 of a total 120 (25%) possible pro re nata re-Rx's had been given. Combination therapy resulted in a median number of 3.5 re-treatments at and including month 12.


CONCLUSIONS
Combination therapy IBI-20089 and ranibizumab was well-tolerated and resulted in fewer ranibizumab retreatments. Transient intraocular pressure elevation and cataract progression occurred.


BACKGROUND
NCT01175395.
Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Illinois Eye and Ear Infirmary, Marion Schenk Esq Chair, Chicago, Illinois, USA.
Jennifer I
JI
Lim
Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Illinois Eye and Ear Infirmary, Marion Schenk Esq Chair, Chicago, Illinois, USA.
Marcia
M
Niec
Icon Bioscience, Sunnyvale, California, USA.
Vernon
V
Wong
D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D000069579:Ranibizumab; D041623:Tomography, Optical Coherence; D014222:Triamcinolone Acetonide / Q000009:adverse effects / Q000627:therapeutic use*; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity; D057135:Wet Macular Degeneration / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology
D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D003692:Delayed-Action Preparations; D005938:Glucocorticoids; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D014222:Triamcinolone Acetonide; D000069579:Ranibizumab
Clinical Trial; Macula; Treatment Medical