Clinical trial NCT00470678: EXTEND III - Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Choroidal Neovascularization
Age-Related Macular Degeneration
Keywords: Age-related
macular
degeneration
AMD
Ranibizumab
Anti-VEGF
choroidal
neovascularization
CNV
Asian patients
Korea
Taiwan
associated
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-05-08
Enrollment: 95
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.
* 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

Primary outcomes:
measure: 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
timeFrame: Baseline, Month 4 and Month 12
Secondary outcomes:
measure: Changes in the retinal structure from baseline as assessed by fundus photography and fluorescein angiography, Month 4 and Month 12
timeFrame: Month 4 and Month 12
measure: Safety by rates of adverse events and serious adverse events, ophthalmic examinations, tonometry, and vital signs, baseline, Month 4, Month 6 and Month 12
timeFrame: Baseline, Month 4, Month 6 and Month 12
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Pusan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: LinKou
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative site
Study officials:
affiliation: Novartis
name: Novartis Pharma
role: STUDY_CHAIR
References:
citation: Kwon OW, Lee FL, Chung H, Lai CC, Sheu SJ, Yoon YH; EXTEND III study group. EXTEND III: efficacy and safety of ranibizumab in South Korean and Taiwanese patients with subfoveal CNV secondary to AMD. Graefes Arch Clin Exp Ophthalmol. 2012 Oct;250(10):1467-76. doi: 10.1007/s00417-012-1970-3. Epub 2012 Mar 2.