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

Novartis2 sites in 1 country95 target enrollmentJune 2007

ConditionsChoroidal Neovascularization Age-Related Macular Degeneration

Interventionsranibizumab

Drugsranibizumab

Overview

Phase: Phase 3
Intervention: ranibizumab
Conditions: Choroidal Neovascularization
Sponsor: Novartis
Enrollment: 95
Locations: 2
Primary Endpoint: 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
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2007

End Date

November 2008

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

1

Ranibizumab

Intervention: ranibizumab

Outcomes

Primary Outcomes

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 Outcomes

Changes in the retinal structure from baseline as assessed by fundus photography and fluorescein angiography, Month 4 and Month 12(Month 4 and Month 12)
Safety by rates of adverse events and serious adverse events, ophthalmic examinations, tonometry, and vital signs, baseline, Month 4, Month 6 and Month 12(Baseline, Month 4, Month 6 and Month 12)