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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Choroidal Neovascularization Age-Related Macular Degeneration Drug: ranibizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Ranibizumab
 Drug: ranibizumab
Other Name: Lucentis, RFB002


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470678


Locations
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Korea, Republic of
Novartis Investigative Site
Daegu, Korea, Republic of
Novartis Investigative Site
Pusan, Korea, Republic of
Novartis Investigative site
Seoul, Korea, Republic of
Taiwan
Novartis Investigative Site
Kaohsiung, Taiwan
Novartis Investigative Site
LinKou, Taiwan
Novartis Investigative site
Taipei, Taiwan
Sponsors and Collaborators
Novartis
Investigators
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Study Chair: Novartis Pharma Novartis
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00470678    
Other Study ID Numbers: CRFB002A2304
First Posted: May 8, 2007    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Novartis:
Age-related
macular
degeneration
AMD
Ranibizumab
Anti-VEGF
choroidal
 neovascularization
CNV
Asian patients
Korea
Taiwan
associated
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
 Uveal Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents