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

• ClinicalTrials.gov Identifier: NCT00470678
• Recruitment Status: Completed
• First Posted: May 8, 2007
• Last Update Posted: November 18, 2016
• Sponsor: Novartis
• Information provided by (Responsible Party): Novartis

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Choroidal Neovascularization; Age-Related Macular Degeneration	Drug: ranibizumab	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 95 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: June 2007
• Actual Primary Completion Date: November 2008
• Actual Study Completion Date: November 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Ranibizumab	Drug: ranibizumab; Other Name: Lucentis, RFB002

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: Baseline, Month 4 and Month 12 ]

Secondary Outcome Measures :

1. Changes in the retinal structure from baseline as assessed by fundus photography and fluorescein angiography, Month 4 and Month 12 [ Time Frame: Month 4 and Month 12 ]
2. Safety by rates of adverse events and serious adverse events, ophthalmic examinations, tonometry, and vital signs, baseline, Month 4, Month 6 and Month 12 [ Time Frame: Baseline, Month 4, Month 6 and Month 12 ]

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Korea, Republic of

Novartis Investigative Site

Daegu, Korea, Republic of

Novartis Investigative Site

Pusan, Korea, Republic of

Novartis Investigative site

Seoul, Korea, Republic of

Taiwan

Novartis Investigative Site

Kaohsiung, Taiwan

Novartis Investigative Site

LinKou, Taiwan

Novartis Investigative site

Taipei, Taiwan

Sponsors and Collaborators

Novartis

Investigators

• Study Chair: Novartis Pharma; Novartis

More Information

Publications of Results:

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.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00470678
• Other Study ID Numbers: CRFB002A2304
• First Posted: May 8, 2007
• Last Update Posted: November 18, 2016
• Last Verified: November 2016

Keywords provided by Novartis:

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

Additional relevant MeSH terms:

Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic; Retinal Degeneration; Retinal Diseases; Eye Diseases; Metaplasia; Pathologic Processes; Choroid Diseases; Uveal Diseases; Ranibizumab; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents