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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00470678
First received: May 7, 2007
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Choroidal Neovascularization
Age-Related Macular Degeneration
Drug: ranibizumab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 95
Study Start Date: June 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ranibizumab
Drug: ranibizumab
Other Name: Lucentis, RFB002

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470678

Locations
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
Study Chair: Novartis Pharma Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00470678     History of Changes
Other Study ID Numbers: CRFB002A2304
Study First Received: May 7, 2007
Last Updated: April 27, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health

Keywords provided by Novartis:
Age-related
macular
degeneration
AMD
Ranibizumab
Anti-VEGF
choroidal
neovascularization
CNV
Asian patients
Korea
Taiwan
associated

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on April 22, 2014