Age-related macular degeneration (AMD) is the leading cause of visual impairment and social blindness in people 60 years or older. Approximately 80% of patients with severe visual loss exhibit neovascular AMD with choroidal neovascularization (CNV). Newly formed vessels invade the retinal pigment epithelium (RPE) and neural retina, causing edema and hemorrhage, ultimately inducing damage or apoptotic cell death of photoreceptors.
Conditions
Interventions
Trade Name: Lucentis®
Product Name: Lucentis®
Pharmaceutical Form: Injection*
Sponsors
St. Eriks Eye Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with neovascular AMD age 50 years or older who have a visual acuity of 0.1 (20/200) or better Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients aged < 50 years BCVA < 0.1 Subfoveal fibrosis or atrophy Previous treatment for neovascular AMD CNV of other causes that AMD Intraocular surgery within 3 months Untreated glaucoma Inflammation or infection in study eye Retinal vascular disease of any origin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the number of retreatments with intravitreal ranibizumab after combined treatment with transpupillary thermotherapy (TTT) or sham TTT in patients with neovascular AMD. ;Secondary Objective: To compare the best corrected visual acuity (BCVA) between the treatment groups. To compare the proportion of patients with stabilized or improved BCVA.;Primary end point(s): The proportion of patients receiving 5 intravitreal injections or less of ranibizumab per year after the initial loading dose of ranibizumab | — |
Countries
Sweden
Outcome results
None listed