Status:
COMPLETED
EXTEND III - Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Lead Sponsor:
Novartis
Conditions:
Choroidal Neovascularization
Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 degen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00470678
Start Date
June 1 2007
End Date
November 1 2008
Last Update
November 18 2016
Active Locations (6)
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1
Novartis Investigative Site
Daegu, South Korea
2
Novartis Investigative Site
Pusan, South Korea
3
Novartis Investigative site
Seoul, South Korea
4
Novartis Investigative Site
Kaohsiung City, Taiwan