Neovascular Age-related Macular Degeneration
Conditions
Keywords
Neovascularization, Age-related macular degeneration, Ranibizumab (Lucentis), Optical coherence tomography, Intravitreal injection
Brief summary
This study was designed to evaluate a variable dosing regimen with intravitreal ranibizumab for the treatment of patients with neovascular age-related macular degeneration (AMD) in the Prospective OCT Imaging of Patients with Neovascular AMD Treated with Intra-Ocular Ranibizumab (PrONTO) study.
Detailed description
In this 2-year open-label, prospective, single-center, uncontrolled, investigator sponsored clinical study, neovascular AMD patients with subfoveal CNV (N=40) and a central retinal thickness of at least 300 µm as measured by optical coherence tomography (OCT) were enrolled to receive 3 consecutive monthly intravitreal injections of ranibizumab (0.5 mg). Thereafter, retreatment with ranibizumab was performed if one of the following changes were observed between visits: a loss of 5 letters in conjunction with fluid in the macula as detected by OCT, an increase in OCT central retinal thickness of at least 100 μm, new onset classic CNV, new macular hemorrhage, or persistent macular fluid following an injection of ranibizumab at the prior study visit.
Interventions
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 50 years or older * Active primary or recurrent macular neovascularization secondary to age-related macular degeneration (AMD) involving the central fovea in the study eye with evidence of disease progression * OCT central retinal thickness ≥ 300 microns * Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/400 (Snellen equivalent) in the study eye
Exclusion criteria
* More than 3 prior treatments with verteporfin photodynamic therapy * Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors) * Previous subfoveal focal laser photocoagulation in the study eye * Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding day 0 * Subfoveal fibrosis or atrophy in the study eye * History of vitrectomy surgery in the study eye * Aphakia or absence of the posterior capsule in the study eye * History of idiopathic or autoimmune-associated uveitis in either eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in visual acuity vs baseline | — |
| Change in OCT central retinal thickness vs baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of injections over 1 year | — |
| Number of consecutive monthly injections until fluid-free | — |
| Injection free interval | — |
| Correlations of injection frequency with baseline lesion characteristics and visual acuity | — |
Countries
United States
Outcome results
None listed