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

NCT00470678 | Completed Phase 3

• 1 other identifier: CRFB002A2304
• Study Type: interventional
• Target: 95
• Locations: 2 countries
• Sites: 6

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.

Conditions

Choroidal Neovascularization; Age-Related Macular Degeneration

Keywords

Age-related; macular; degeneration; AMD; Ranibizumab; Anti-VEGF; choroidal; neovascularization; CNV; Asian patients; Korea; Taiwan; associated

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

1

EXPERIMENTAL

Ranibizumab

Drug: ranibizumab

Interventions

ranibizumab DRUG

Also known as: Lucentis, RFB002

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (6)

Novartis Investigative Site

Daegu, South Korea

Location

Novartis Investigative Site

Pusan, South Korea

Location

Novartis Investigative site

Seoul, South Korea

Location

Novartis Investigative Site

Kaohsiung City, Taiwan

Location

Novartis Investigative Site

Linkou District, Taiwan

Location

Novartis Investigative site

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 22382503 RESULT

MeSH Terms

Conditions

Choroidal Neovascularization; Macular Degeneration; Neovascularization, Pathologic

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Novartis Pharma

  Novartis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2007
• First Posted: May 8, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

KR (3); TW (3)