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

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.

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Dexamethasone intravitreal implant combined with anti-VEGF in patients with neovascular age related macular degeneration resistant to anti-VEGF alone

Acta Ophthalmologica ◽

10.1111/j.1755-3768.2017.0f027 ◽

2017 ◽

Vol 95 ◽

Author(s):

G. Damico Ricci ◽

E. Giancipoli ◽

F. Boscia ◽

G. Zasa ◽

G. Sotgiu ◽

...

Keyword(s):

Macular Degeneration ◽

Age Related Macular Degeneration ◽

Dexamethasone Intravitreal Implant ◽

Anti Vegf ◽

Age Related ◽

Intravitreal Implant

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Simultaneous Dexamethasone Intravitreal Implant and Anti-VEGF Therapy for Neovascular Age-Related Macular Degeneration Resistant to Anti-VEGF Monotherapy

Journal of VitreoRetinal Diseases ◽

10.1177/2474126416683299 ◽

2017 ◽

Vol 1 (1) ◽

pp. 65-74 ◽

Cited By ~ 4

Author(s):

Bozho Todorich ◽

Aristomenis Thanos ◽

Yoshihiro Yonekawa ◽

Gerta Mane ◽

Madeleine Hasbrook ◽

...

Keyword(s):

Macular Degeneration ◽

Combined Treatment ◽

Case Series ◽

Dual Therapy ◽

Age Related Macular Degeneration ◽

Treatment Resistant ◽

Dexamethasone Intravitreal Implant ◽

Anti Vegf ◽

Age Related ◽

Intravitreal Implant

Purpose: To evaluate the efficacy of a dexamethasone intravitreal implant in combination with intravitreal anti-vascular endothelial growth factor (VEGF) agents for treatment-resistant neovascular age-related macular degeneration (nvAMD). Methods: This study was designed as a single-center, retrospective interventional case series. Consecutive patients with treatment-resistant nvAMD underwent simultaneous combined injection of anti-VEGF agent and dexamethasone intravitreal implant. Eighteen patients with mean age of 81.5 years were included. Patients received an average of 26.3 anti-VEGF injections before dual therapy, with a mean follow-up of 8.2 months after dual therapy. Results: Dual therapy produced a significant mean decrease in central foveal thickness (126.3 μm), compared to a mean increase in 29.9 μm when treated with anti-VEGF monotherapy ( P = .0017). Patients also had a mean decrease in macular cube volume of −0.85 mm3 with dual therapy compared to anti-VEGF monotherapy ( P = .0014). There was a moderate correlation between the number of prior anti-VEGF injections and the magnitude of anatomic response, suggesting that shorter disease duration may positively influence response to combined treatment. Although there was a slight trend toward improved mean visual acuity after dual therapy, these differences did not reach statistical significance. Nevertheless, with combination treatment, 33% of patients gained 1 or more lines of vision. Dual therapy resulted in a significantly lower number of required anti-VEGF injections (4.25 vs 5.33) and an increase in the anti-VEGF injection-free interval to 1.41 months from 1.12 months during the 6 months following dual therapy compared to the same interval before dual therapy. Dual therapy was well tolerated; 2 eyes developed mild intraocular pressure elevation effectively managed with topical therapy and 1 patient developed worsening cataract. Conclusions: Combined treatment of anti-VEGF with dexamethasone intravitreal implant is a viable alternative for treatment-resistant nvAMD and may reduce treatment burden. Earlier treatment with dual therapy may be beneficial to maximize anatomic and visual outcomes in these patients.

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