None listed
Conditions
Brief summary
The advent of anti-vascular endothelial growth factor (anti-VEGF) intravitreal therapy introduced a new standard of care for patients with neovascular age-related macular degeneration (wet-AMD). Although anti-VEGFs are effective to prevent severe visual loss in most cases, often promoting a significant visual improvement, there are some patients with wet-AMD who continue to experience a visual deterioration despite an adequate treatment. Long-lasting intraretinal or subretinal fluid (IRF/SRF) may induce irreversible damage to retinal structures, preventing optimal visual recovery. Moreover, the need for frequent treatments for prolonged periods adds substantial burdens and safety concerns for these patients. Inflammation is involved in both the beginning and the progression of AMD. To counteract inflammation could lead to a better control of this pathology. The complementary action of intravitreal steroid injections in wet-AMD dates back to the combination of intravitreal triamcinolone acetonide (TA) with photodynamic therapy (PDT). The purpose of this study was to evaluate the anatomical and visual outcomes in patients with wet-AMD and persistent IRF/SRF, after adding dexamethasone intravitreal implant to the already on-going anti-VEGF therapy.
Interventions
Patients belonging to the treatment group were treated with a single Intravitreal dexamethasone injection (700 µg dexamethasone intravitreal
implant) at baseline. Starting from month one, the treatment group continued intravitreal anti-VEGF injection therapy according to the former on-going anti-VEGF intravitreal therapy (ranibizumab 0.5 mg or aflibercept 2 mg) with an as-needed regimen,
No further injections of Intravitreal dexamethasone were administered during the study.
Retreatment criteria
Patients belonging to the treatment group were treated with a single Intravitreal dexamethasone injection (700 µg dexamethasone intravitreal implant) at baseline. Starting from month one, the treatment group continued intravitreal anti-VEGF injection therapy according to the former on-going anti-VEGF intravitreal therapy (ranibizumab 0.5 mg or aflibercept 2 mg) with an as-needed regimen, No further injections of Intravitreal dexamethasone were administered during the study. Retreatment criteria for the as-needed regimen with Anti-VEGF drugs were: BCVA loss greater than, or equal to 5 ETDRS letters Recurrence or persistence of any fluid in the macula on SD-OCT A10% increase in CSFT in comparison with the previous value New macular hemorrhages New area of classic CNV Development of new retinal PED or increase in size of an already existent PED
Sponsors
A.O.U. Sassari
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
We enrolled only patients diagnosed with subfoveal AMD-related CNV with evidence of persistent IRF/SRF, despite at least 4 consecutive monthly injections of anti-VEGF agents, administered just before inclusion in the study
Exclusion criteria
Retinopathy other than AMD Uncontrolled glaucoma (IOP greater than or equal to 25 mmHg) NVG Active inflammation and/or infection in the study eye History of vitrectomy at any time Cataract surgery within the previous 3 months On-going therapy with other systemic or intravitreal steroids Other previous treatment for wet-AMD
Outcome results
None listed