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.

PURPOSE: 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.

TRIAL REGISTRATION NUMBER: NCT01175395.