A prospective, randomized, masked and controlled trial of intravitreal ranibizumab (Lucentis®) combined with transpupillary thermotherapy (TTT) in patients with neovascular age-related macular degeneration (AMD)
- Conditions
- 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.
- Registration Number
- EUCTR2007-005462-12-SE
- Lead Sponsor
- St. Eriks Eye Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br><br>;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
- Secondary Outcome Measures
Name Time Method