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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00138632




Registration number
NCT00138632
Ethics application status
Date submitted
29/08/2005
Date registered
30/08/2005
Date last updated
14/11/2008

Titles & IDs
Public title
Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
Scientific 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
Secondary ID [1] 0 0
CPTK787E2201
Universal Trial Number (UTN)
Trial acronym
ADVANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wet Age-Related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PTK787
Treatment: Drugs - PTK787
Treatment: Drugs - Placebo

Experimental: 1 -

Experimental: 2 -

Placebo Comparator: 3 -


Treatment: Drugs: PTK787
Visudyne® + PTK787, 500 mg/day

Treatment: Drugs: PTK787
Visudyne® + PTK787 1000 mg/day

Treatment: Drugs: Placebo
Visudyne® + Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months
Timepoint [1] 0 0
up to 12 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
from baseline up to 3 months

Eligibility
Key inclusion 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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Parramatta
Recruitment hospital [2] 0 0
Novartis Investigational Site - Sydney
Recruitment hospital [3] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [4] 0 0
Novartis Investigative Site - East Melbourne
Recruitment postcode(s) [1] 0 0
2150 - Parramatta
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
South Dakota

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00138632
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Customer Information
Address 0 0
Novartis
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00138632