Age-Related Macular Degeneration (ARMD) MedDRA version: 9.1 Level: LLT Classification code 10064930 Term: Age-related macular degeneration
Conditions
Sponsors
The Eye Hospital Rotterdam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Informed consent - Endophthalmitis risks have been made clear - No preference to paritcipate in the Infliximab for ARMD trial - Age = 65 years - Exudative subfoveolar age related macular degeneration - No significant other ocular disorders affecting visual acuity - Not immunocompromised - No allergy for fluorescein or ICG dye injections - No treatment for ARMD or other retinal problem in the 3 months prior to trial start - No planned ocular surgery in the first year after trial start Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: None.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the optimal Avastin injection schedule.;Secondary Objective: To determine if Visual Acuity is a sufficiently adequate parameter for follow-up of exudative macular degeneration. To determine an optimal schedule for comparison with Lucentis. ;Primary end point(s): - Visual acuity (in lines lost or gained) at 6 months and 1 year. - OCT outcomes at 6 months and 1 year. | — |
Countries
Netherlands
Outcome results
None listed