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Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD) (ADVANCE)

Primary Purpose

Wet Age-Related Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PTK787
PTK787
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Age-Related Macular Degeneration focused on measuring Wet Age-related macular degeneration, PTK787

Eligibility Criteria

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

Inclusion criteria Male ≥ 65 years old or female ≥ 50 years old, with aged related macular degeneration Patients with subfoveal choroidal neovascularization secondary to AMD Exclusion criteria Eye disease that may result in visual loss during the study Uncontrolled high blood pressure, despite chronic stable treatment: systolic ≥ 140 mmHg, Diastolic ≥ 90 mmHg Chronic therapy with topical, local or systemic corticosteroids. Use of other investigational drugs within 30 days Pregnant or nursing (lactating) women. Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Retina-Vitreous Associates Medical Group
  • Porter Adventist Hospital, Eye Lab
  • USF Eye Institute
  • Springfield Clinic, LLP
  • Wilmer Eye Institute
  • Lahey Clinic Medical Center, Eye institute
  • Black Hills Regional Eye Institute
  • Novartis Investigative Site
  • Novartis Investigational Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months

Secondary Outcome Measures

Change in macular edema from Baseline up to Month 3 Change in best-corrected visual acuity (BCVA) from Baseline up to Month 3 Change in size of fluorescein leakage Baseline up to Month 3

Full Information

First Posted
August 29, 2005
Last Updated
November 12, 2008
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00138632
Brief Title
Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
Acronym
ADVANCE
Official Title
A Randomized, Double-Masked, Multicenter, Phase I/II Study of the Safety of PTK787 Administered to Patients With Predominantly Classic , Minimally Classic or Occult With no Classic Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
This study evaluates the tolerability and safety of 3 months treatment with PTK787 tablets given daily. It also explores the efficacy of the compound in patients with wet age-related macular edema. In Cohort 1 verteporfin/PDT is the active control. The protocol was amended to reflect the current standard of care for AMD. As a result, ranibizumab is the active control for Cohort 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Age-Related Macular Degeneration
Keywords
Wet Age-related macular degeneration, PTK787

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PTK787
Intervention Description
Visudyne® + PTK787, 500 mg/day
Intervention Type
Drug
Intervention Name(s)
PTK787
Intervention Description
Visudyne® + PTK787 1000 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Visudyne® + Placebo
Primary Outcome Measure Information:
Title
Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Change in macular edema from Baseline up to Month 3 Change in best-corrected visual acuity (BCVA) from Baseline up to Month 3 Change in size of fluorescein leakage Baseline up to Month 3
Time Frame
from baseline up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Male ≥ 65 years old or female ≥ 50 years old, with aged related macular degeneration Patients with subfoveal choroidal neovascularization secondary to AMD Exclusion criteria Eye disease that may result in visual loss during the study Uncontrolled high blood pressure, despite chronic stable treatment: systolic ≥ 140 mmHg, Diastolic ≥ 90 mmHg Chronic therapy with topical, local or systemic corticosteroids. Use of other investigational drugs within 30 days Pregnant or nursing (lactating) women. Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Customer Information
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Porter Adventist Hospital, Eye Lab
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
USF Eye Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-4742
Country
United States
Facility Name
Springfield Clinic, LLP
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Lahey Clinic Medical Center, Eye institute
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
05770
Country
United States
Facility Name
Novartis Investigative Site
City
Parramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Novartis Investigational Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Novartis Investigative Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Novartis Investigative Site
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia

12. IPD Sharing Statement

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Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)

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