EXTEND III - Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
NCT ID: NCT00470678
Last Updated: 2016-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
95 participants
INTERVENTIONAL
2007-06-30
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Ranibizumab
ranibizumab
Interventions
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ranibizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharma
Role: STUDY_CHAIR
Novartis
Locations
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Novartis Investigative Site
Daegu, , South Korea
Novartis Investigative Site
Pusan, , South Korea
Novartis Investigative site
Seoul, , South Korea
Novartis Investigative Site
Kaohsiung City, , Taiwan
Novartis Investigative Site
Linkou District, , Taiwan
Novartis Investigative site
Taipei, , Taiwan
Countries
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References
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Kwon OW, Lee FL, Chung H, Lai CC, Sheu SJ, Yoon YH; EXTEND III study group. EXTEND III: efficacy and safety of ranibizumab in South Korean and Taiwanese patients with subfoveal CNV secondary to AMD. Graefes Arch Clin Exp Ophthalmol. 2012 Oct;250(10):1467-76. doi: 10.1007/s00417-012-1970-3. Epub 2012 Mar 2.
Other Identifiers
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CRFB002A2304
Identifier Type: -
Identifier Source: org_study_id