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

Novartis

Status and phase

Completed

Phase 3

Conditions

Choroidal Neovascularization

Age-Related Macular Degeneration

Treatments

Drug: ranibizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00470678

CRFB002A2304

Details and patient eligibility

About

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.

Enrollment

95 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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