Age-related Macular Degeneration, Neovascular Macular Degeneration, Pigment Epithelial Detachment, Wet Macular Degeneration
Conditions
Keywords
ranibizumab, Lucentis, Pigment Epithelial Detachment, Macular Degeneration, PrONTO
Brief summary
Patients with neovascular Age-related macular degeneration (AMD) and the particular feature of pigment epithelial detachments (PEDs) were not studied in the Phase III trials for ranibizumab (Lucentis). The PrONTO study was the first ranibizumab study to enroll such patients but only treated with ranibizumab until fluid within the layers of the retina was absent, not until the entire PED was absent. This study hypothesizes that there may be a difference in benefit between patients treated until just the retinal edema is gone and those in which the retinal edema and PED are both gone.
Interventions
DRUGranibizumab
0.5mg injection monthly according to protocol for one year
Sponsors
Genentech, Inc.
Pacific Eye Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Neovascular age-related macular degeneration patients over age 50 * Presence of a pigment epithelial detachment on optical coherence tomography * Initial or recurrent disease * Previous treatment allowed * Visual acuity between Snellen 20/40 - 20/400
Exclusion criteria
* More than three previous treatments with PDT or other radiation/laser therapy * Previous vitrectomy or other AMD surgical intervention * Severe scarring or severe concurrent ocular disease (uncontrolled glaucoma) Patients eligible for the study are randomized into one of two groups. Group 1 receives injections of ranibizumab until retinal edema is resolved. Group 2 receives ranibizumab injections until both retinal edema and the PED are resolved. Study duration is one year with visits once per month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in visual acuity from baseline over 12 months | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to OCT resolution of macular edema and pigment epithelial detachment | One year |
| Proportion of patients with complete resolution of PED at 6 and 12 months | 12 months |
| Durability of outcome: time from last ranibizumab injection to retreatment | One year |
Countries
United States
Outcome results
None listed