Dexamethasone Intravitreal Implant as Adjunctive Therapy to Ranibizumab in Neovascular Age-Related Macular Degeneration: A Multicenter Randomized Controlled Trial

Abstract

Purpose: To evaluate the efficacy and safety of dexamethasone intravitreal implant 0.7 mg (DEX) as adjunctive therapy to ranibizumab in neovascular age-related macular degeneration (nvAMD). Procedures: This was a 6-month, single-masked, multicenter study. Patients were randomized to DEX implant (n = 123) or sham procedure (n = 120) and received 2 protocol-mandated intravitreal ranibizumab injections. The main outcome measure was injection-free interval to first as-needed ranibizumab injection. Results: DEX increased the injection-free interval versus sham (50th percentile, 34 vs. 29 days; 75th percentile, 85 vs. 56 days; p = 0.016). 8.3% of DEX versus 2.5% of sham-treated patients did not require rescue ranibizumab (p = 0.048). Visual acuity and retinal thickness outcomes were similar in DEX and sham-treated patients. Only reports of conjunctival hemorrhage (18.2 vs. 8.5%) and intraocular pressure elevation (13.2 vs. 4.2%) were significantly different in the DEX versus the sham treatment groups. Conclusion: DEX reduced the need for adjunctive ranibizumab treatment and showed acceptable tolerability in nvAMD patients.

The Intraocular Cytokine Profile and Therapeutic Response in Persistent Neovascular Age-Related Macular Degeneration

“…[20][21][22] Targeting angiogenesis and inflammation during disease progression seems to be reasonable, as inflammation has been shown to be involved in the pathogenesis of ME, and the possible benefit of a multimodal treatment approach including steroids has been recently investigated. 13,15 To date, limited evidence exists about the use of additional corticosteroid treatment in patients with nAMD. Hence, we evaluated the influence of anti-VEGF monotherapy or anti-VEGF and corticosteroid combined treatment on intraocular cytokine concentrations in persistent or recurrent nAMD patients.…”

“…As inflammation is involved in the complex pathogenesis of nAMD, the role of intravitreal steroids, either as monotherapy or combined treatment, has been investigated to treat CNV lesions. 13,14 A multimodal treatment approach targeting angiogenesis and inflammation has recently been iovs.arvojournals.org j ISSN: 1552-5783 shown to reduce the amount of retreatments. 13,15 However, limited clinical evidence exists about the use of combined treatments in the management of nAMD patients.…”

Widening use of dexamethasone implant for the treatment of macular edema

“…Compared with ranibizumab monotherapy, studies showed no long-term improvement of best corrected visual acuity (BCVA) and reduction of CMT; 22 – 25 however, DEX implant in some cases allowed a reduced number of anti-VEGF injections. 23 , 24 …”

Macular Edema of Choroidal Origin

“…In a 6-month, singlemasked, multicenter study, the dexamethasone implant and ranibizumab (123 patients) provided the same efficacy and allowed a modest statistically significant reduction in the frequency of ranibizumab injections compared with ranibizumab used alone (120 patients). Increased IOP in this study (IOP ≥ 25 mm Hg) occurred in 18.2% of patients treated with the dexamethasone implant (Kuppermann et al, 2015) 67 . A sustained drug intravitreal delivery system with fluocinolone acetonide had the same goal in diabetic macular edema.…”