Abstract
Purpose:
To investigate safety and evidence of efficacy of IBI-20089, an intravitreal, injectable liquid sustained drug delivery system formulated with triamcinolone acetonide (TA) in combination with ranibizumab (Lucentis) for choroidal neovascularization (CNV) secondary to age related macular degeneration (AMD).
Methods:
Patients received a single intravitreal injection of IBI-20089 containing either 6.9 mg (25 ul) TA (Cohort 1) or 13.8 mg (50 ul) TA (Cohort 2) followed one week later by an intravitreal injection of 0.5 mg ranibizumab. A sequential cohort dosing scheme was used. Patients were seen monthly and underwent best corrected visual acuity testing, slit lamp biomicroscopy, dilated ophthalmoscopy, fundus photos and optical coherence tomography (OCT). Patients received pro re nata (PRN) monthly dosing of ranibizumab. Ocular adverse events and number of ranibizumab retreatments were determined.
Results:
: Patients ranged in age from 59 to 81 years old (mean 73.4 years). Six patients had received prior treatment with ranibizumab (range 4 to 16 injections; median 9). Mean baseline OCT CST was 406 u (median 324 u) in Cohort 1 and 291 u (median 286 u) in Cohort 2. All patients completed one year follow-up. All patients showed a substantial drop in OCT CST as early as one week following therapy. No serious related adverse events occurred. Ocular adverse events included mild elevation of intraocular pressure (IOP) in 8 patients and cataract progression in 3 of the 5 phakic patients. At one year, 30 of a total 120 (25 %) possible PRN re-Rx’s had been given. Combination therapy resulted in a median number of 2 re-treatments at and including month 12.
Conclusions:
Combination therapy using IBI-20089 and ranibizumab was well-tolerated and resulted in a lower rate of ranibizumab retreatments. Transient IOP elevation and cataract progression occurred
Keywords: 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials •
412 age-related macular degeneration •
503 drug toxicity/drug effects