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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Choroidal Neovascularization, Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: ranibizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ranibizumab | Drug: ranibizumab<br> <br> * Other names: Lucentis, RFB002;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Baseline, Month 4 and Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age-related, macular, degeneration, AMD, Ranibizumab, Anti-VEGF, choroidal, neovascularization, CNV, Asian patients, Korea, Taiwan, associated