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

Age-Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470678
• Other study ID #: CRFB002A2304
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2007
• Last updated: November 16, 2016
• Start date: June 2007
• Est. completion date: November 2008

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• ranibizumab

Locations

Country	Name	City	State
Korea, Republic of	Novartis Investigative Site	Daegu
Korea, Republic of	Novartis Investigative Site	Pusan
Korea, Republic of	Novartis Investigative site	Seoul
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	LinKou
Taiwan	Novartis Investigative site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Korea, Republic of,  Taiwan, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes

External Links

•   Results for CRFB002A2304 from the Novartis Clinical Trials Website