Age-Related Macular Degeneration, Choroidal Neovascularization
Conditions
Keywords
Age-related, macular, degeneration, AMD, Ranibizumab, Anti-VEGF, choroidal, neovascularization, CNV, Asian patients, Korea, Taiwan, associated
Brief summary
This study will evaluate efficacy and safety for monthly ranibizumab 0.5 mg intravitreal injections in Asian patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.
Interventions
DRUGranibizumab
Sponsors
Novartis
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
* Male or female Asian patients 50 years of age or greater. * Patients with primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or active occult lesions with no classic component. * Patients who have a BCVA score between 73 and 24 letters (approximately 20/40 to 20/320 Snellen equivalent), inclusively, in the study eye. * Total area of CNV (including both classic and occult components) encompassed within the lesion must be \>= 50% of the total lesion area * Total lesion area must be \<= 12 disc areas
Exclusion criteria
* Patients who have in the fellow eye a Snellen equivalent below 20/200 * Presence of angioid streaks, presumed ocular histoplasmosis syndrome, myopia (exceeding -8 diopters), or CNV secondary to causes other than AMD in the study eye * Subfoveal fibrosis or atrophy in the study eye * Total area of CNV (including both classic and occult components) encompassed within the lesion must be \>= 50% of the total lesion area * Total lesion area must be \<= 12 disc areas * Vitreous hemorrhage, retinal tear or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye. * Active, or history of, ocular inflammation or infection in the study eye within the last 30 days prior to screening. * Uncontrolled glaucoma in the study eye * Treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary thermotherapy within 30 days prior to screening * Previous treatment with anti-angiogenic drugs (pegaptanib, ranibizumab, bevacizumab, anecortave acetate, corticosteroids, protein kinase C inhibitors, squalamine, siRNA, VEGF-Trap etc.) for neovascular AMD in the study eye. Treatment of the fellow eye is permitted if administered \> 30 days before screening. * History of intraocular surgery in the study eye including pars plana vitrectomy, except for uncomplicated cataract surgery more than 60 days prior to screening * History of YAG laser posterior capsulotomy in the study eye within 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in best-corrected visual acuity (BCVA) from Baseline, Month 4 and Month 12 as assessed with ETDRS (Early Treatment for Diabetic Retinopathy Study)-like charts at a distance of four meters | Baseline, Month 4 and Month 12 |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the retinal structure from baseline as assessed by fundus photography and fluorescein angiography, Month 4 and Month 12 | Month 4 and Month 12 |
| Safety by rates of adverse events and serious adverse events, ophthalmic examinations, tonometry, and vital signs, baseline, Month 4, Month 6 and Month 12 | Baseline, Month 4, Month 6 and Month 12 |
Countries
South Korea, Taiwan
Outcome results
None listed