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EXTEND III - Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)

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ClinicalTrials.gov Identifier: NCT00470678
Recruitment Status : Completed
First Posted : May 8, 2007
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis

Tracking Information
First Submitted Date  ICMJE May 7, 2007
First Posted Date  ICMJE May 8, 2007
Last Update Posted Date November 18, 2016
Study Start Date  ICMJE June 2007
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2008)
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 [ Time Frame: Baseline, Month 4 and Month 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2007)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2008)
  • Changes in the retinal structure from baseline as assessed by fundus photography and fluorescein angiography, Month 4 and Month 12 [ Time Frame: 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 [ Time Frame: Baseline, Month 4, Month 6 and Month 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2007)
  • Changes in the retinal structure from baseline as assessed by fundus photography and fluorescein angiography, Month 4, Month 6 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EXTEND III - Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Official Title  ICMJE An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Ranibizumab (0.5 mg) in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration Over 12 Months
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Choroidal Neovascularization
  • Age-Related Macular Degeneration
Intervention  ICMJE Drug: ranibizumab
Other Name: Lucentis, RFB002
Study Arms  ICMJE Experimental: 1
Ranibizumab
Intervention: Drug: ranibizumab
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2008)
95
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2007)
90
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00470678
Other Study ID Numbers  ICMJE CRFB002A2304
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Novartis Pharma Novartis
PRS Account Novartis
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP