Age-Related Macular Degeneration, Choroidal Neovascularization
Conditions
Brief summary
Adalimumab is a humanized recombinant monoclonal antibody fragment targeted against tumor necrosis factor. This study will assess the safety and efficacy of intravitreal adalimumab administered in patients with choroidal neovascularization secondary to age-related macular degeneration non-responders to the conventional treatment with intravitreal ranibizumab.
Interventions
DRUGAdalimumab
Intravitreal adalimumab injection (0,1 ml= 50 mcg) in the eye of the included patients. Patients will be followed up every week for a total of 4 weeks, and after every month until 6 months. If it is necessary, repeat the injection every month, maximum three months
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Choroidal neovascularization secondary to age-related macular degeneration non-responders to the conventional treatment with ranibizumab (active choroidal neovascularization after loading phase of one injection per month for three consecutive months, followed by a maintenance phase with 5 injections in the last 12 months or 3 injections in the last 6 months
Exclusion criteria
* Only one functional eye * Hypersensitivity to adalimumab or any component of the formulation * Previous systemic treatment with adalimumab * Cancer * Life expectancy \<1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients proportion with electroretinogram alterations | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Changes in retinal thickness measured by ocular coherence tomography | once a month to 6 months |
| Changes in best corrected visual acuity | once a month to 6 months |
| Incidence of adverse events | until 6 months |
Countries
Spain
Outcome results
None listed