Dexamethasone Intravitreal Implant as Adjunctive Therapy to Ranibizumab in Neovascular Age-Related Macular Degeneration: A Multicenter Randomized Controlled Trial.
Ophthalmologica
; 234(1): 40-54, 2015.
Article
in En
| MEDLINE
| ID: mdl-26088793
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Visual Acuity
/
Wet Macular Degeneration
/
Ranibizumab
Type of study:
Diagnostic_studies
/
Guideline
/
Observational_studies
/
Prognostic_studies
Limits:
Aged80
/
Female
/
Humans
/
Male
Language:
En
Journal:
Ophthalmologica
Year:
2015
Type:
Article
Affiliation country:
United States