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Jennifer I Lim, Marcia Niec, Jessica Sun, vernon Wong; Two Year Results of a Phase 1 Study of the Safety and Tolerability of Combination Therapy Using Sustained Release Intravitreal Triamcinolone Acetonide and at Baseline Followed by Anti-VEGF PRN Treatment for Subfoveal Neovascular AMD. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1654.
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To determine the two year visual and safety outcomes of IBI-20089, an intravitreal, liquid, sustained drug delivery system formulated with triamcinolone acetonide (TA) in combination with ranibizumab (Lucentis) at baseline followed by anti-VEGF as needed treatment for neovascular age related macular degeneration (AMD).
At baseline, patients received a single intravitreal injection of IBI-20089 containing either 6.9 mg (25 ul) TA or 13.8 mg (50 ul) TA followed a week later by intravitreal injection of 0.5 mg ranibizumab. Patients were followed monthly and underwent best corrected visual acuity (VA) testing, slit lamp biomicroscopy, dilated ophthalmoscopy and optical coherence tomography (OCT). Patients received pro re nata (PRN) dosing of ranibizumab in year 1 and then PRN dosing of ranibizumab or aflibercept in year 2.
Patients ranged in age from 59 to 81 years old (mean 73.4 years). Nine of ten patients completed two years of follow-up. (The one patient who missed follow-up had severe geographic atrophy at the end of year 1 in both eyes). No related serious adverse events occurred. At 2 years, ocular adverse events included one eye with elevated intraocular pressure (IOP) of 22 mmHg and cataract progression requiring surgery in 4 of the 5 patients phakic at year 1. All 4 patients had VA improved to or better than baseline VA (20/25, 20/60, 20/50, 20/ 400). Overall, at year 2, VA was > 3 lines better compared with baseline VA in 2 eyes, within 1 line of baseline VA in 5 eyes (20/400, 20/25, 20/60, 20/30, 20/50) and > 3 lines worse than baseline VA in 3 eyes (geographic atrophy causing counts fingers, 20/400; cataract in 1 eye). Compared to one year (where 30 of a total 120 (25 %) possible PRN re-Rx’s had been given), between years 1 and 2, 30 anti-VEGF injections of a total of 120 (25%) possible PRN re-Rx's had been given. If the eyes with GA were excluded, 30 of 96 (31%) possible PRN re-Rx's had been given between years 1 and 2.
<br /> Combination therapy of IBI-20089 and anti-VEGF was well-tolerated at 2 years and resulted in relatively few anti-VEGF retreatments. IOP elevation was uncommon at 2 years. The ocular adverse event of cataract formation was common but had good VA outcomes with surgery.
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