EXTEND III - Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Phase 3
Completed
- Conditions
- Choroidal NeovascularizationAge-Related Macular Degeneration
- Interventions
- Registration Number
- NCT00470678
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 ranibizumab Ranibizumab
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Novartis Investigative Site
🇨🇳LinKou, Taiwan
Novartis Investigative site
🇨🇳Taipei, Taiwan