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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Ranibizumab

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