Dexamethasone Intravitreal Implant Alone And As An Adjunct To Ranibizumab For Choroidal Neovascularization (CNV) Secondary To Age-Related Macular Degeneration (AMD)

1. Harvey Uy¹
2. Sunil Patel²
3. Michael Singer³
4. Ching-Chi Liu⁴
5. Xiao-Yan Li⁴
6. Scott Whitcup⁴

¹Asian Eye Institute, Makati City, Philippines
²Retina Research Institute of Texas, Abilene, TX
³Medical Center Ophthalmology Associates, San Antonio, TX
⁴Allergan, Inc., Irvine, CA

Purpose: To report the efficacy of dexamethasone intravitreal implant (DEX implant) alone and as an adjunct to ranibizumab for treatment of CNV secondary to AMD.

Methods: This open-label, 26-week, phase 2 study enrolled 44 treatment-naive, subfoveal CNV patients with a total lesion size of ≤12 MPS DA, central retinal thickness (CRT) of ≥300μm, and best-corrected visual acuity (BCVA) of ≥19 and ≤75 letters at baseline (day 1). Patients received DEX implant at baseline. Patients received ranibizumab at week 2 or 3 if BCVA was worsened by ≥ 5 letters or from week 4 on for wet AMD at the investigator's discretion. Study endpoints were the mean change from baseline CRT at week 4 (primary), BCVA, and number of ranibizumab injections. For patients who received a ranibizumab injection before week 4, the endpoint values prior to the injection were carried forward for the primary efficacy analysis.

Results: The mean change from baseline CRT at weeks 1, 4, 8, and 26 were, respectively, -40.3, -62.0, -124.6, and -133.7 microns (P<.001 for all compared to baseline). The percentage of patients with ≥15-letter improvement from baseline BCVA was 4.5% and 15.9% at weeks 4 and 26, with a peak response of 20.5% at week 22. The number of ranibizumab injections during the study was 0 in 3 patients (6.8%), 1-3 injections in 17 patients (38.6%), and 4-6 injections in 24 patients (54.5%).

Conclusions: DEX implant alone or as an adjunct to ranibizumab significantly reduced CRT. DEX implant decreased the necessity for repeated ranibizumab injections.