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

Last updated: November 16, 2016
Sponsor: Novartis
Overall Status: Completed

Phase

3

Condition

Aging

Myopic Macular Degeneration

Macular Degeneration

Treatment

N/A

Clinical Study ID

NCT00470678
CRFB002A2304
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female Asian patients 50 years of age or greater.

  • Patients with primary or recurrent subfoveal CNV secondary to AMD, including thosewith predominantly classic, minimally classic or active occult lesions with no classiccomponent.

  • 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 withinthe lesion must be >= 50% of the total lesion area

  • Total lesion area must be <= 12 disc areas

Exclusion

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 withinthe 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 ormacular hole (Stage 3 or 4) in the study eye.

  • Active, or history of, ocular inflammation or infection in the study eye within thelast 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, ortranspupillary 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 ispermitted 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 toscreening

Study Design

Total Participants: 95
Study Start date:
June 01, 2007
Estimated Completion Date:
November 30, 2008

Connect with a study center

  • Novartis Investigative Site

    Daegu,
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Pusan,
    Korea, Republic of

    Site Not Available

  • Novartis Investigative site

    Seoul,
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Kaohsiung,
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    LinKou,
    Taiwan

    Site Not Available

  • Novartis Investigative site

    Taipei,
    Taiwan

    Site Not Available

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