Back to results

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

Primary Purpose

Choroidal Neovascularization, Age-Related Macular Degeneration

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

ranibizumab

About this trial

This is an interventional treatment trial for Choroidal Neovascularization focused on measuring Age-related, macular, degeneration, AMD, Ranibizumab, Anti-VEGF, choroidal, neovascularization, CNV, Asian patients, Korea, Taiwan, associated

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Ranibizumab

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in the retinal structure from baseline as assessed by fundus photography and fluorescein angiography, 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

Full Information

NCT ID

NCT00470678

First Posted

May 7, 2007

Last Updated

November 16, 2016

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00470678

Brief Title

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

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Choroidal Neovascularization, Age-Related Macular Degeneration

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Ranibizumab

Intervention Type

Drug

Intervention Name(s)

ranibizumab

Other Intervention Name(s)

Lucentis, RFB002

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharma

Organizational Affiliation

Novartis

Official's Role

Study Chair

Facility Information:

Facility Name

Novartis Investigative Site

City

Daegu

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Pusan

Country

Korea, Republic of

Facility Name

Novartis Investigative site

City

Seoul

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Kaohsiung

Country

Taiwan

Facility Name

Novartis Investigative Site

City

LinKou

Country

Taiwan

Facility Name

Novartis Investigative site

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

22382503

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs