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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00138632
Other study ID # CPTK787E2201
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received August 29, 2005
Last updated November 12, 2008
Start date September 2005

Study information

Verified date November 2008
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
PTK787
Visudyne® + PTK787, 500 mg/day
PTK787
Visudyne® + PTK787 1000 mg/day
Placebo
Visudyne® + Placebo

Locations

Country Name City State
Australia Novartis Investigative Site East Melbourne Victoria
Australia Novartis Investigative Site Parramatta New South Wales
Australia Novartis Investigational Site Sydney New South Wales
Australia Novartis Investigative Site Westmead New South Wales
United States Wilmer Eye Institute Baltimore Maryland
United States Retina-Vitreous Associates Medical Group Beverly Hills California
United States Porter Adventist Hospital, Eye Lab Denver Colorado
United States Lahey Clinic Medical Center, Eye institute Peabody Massachusetts
United States Black Hills Regional Eye Institute Rapid City South Dakota
United States Springfield Clinic, LLP Springfield Illinois
United States USF Eye Institute Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months up to 12 months Yes
Secondary 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 from baseline up to 3 months Yes
See also
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Completed NCT03066258 - Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD Trial Phase 1/Phase 2
Terminated NCT01086761 - Study of MP0112 Intravitreal Injection in Patients With Wet Age Related Macular Degeneration Phase 1
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Completed NCT04884399 - Phase I Study to Compare CMAB818 Injection and Lucentis® in Patients With Wet AMD Phase 1
Completed NCT04964089 - A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) Phase 3
Withdrawn NCT01339949 - Study to Evaluate the Safety and Effectiveness of IRay in Wet Age-related Macular Degeneration (AMD) Patients With Recurrent Leakage Secondary to Choroidal Neovascularisation (CNV) N/A
Terminated NCT00139282 - A Safety and Efficacy Study of Squalamine Lactate for Injection (MSI-1256F) for "Wet" Age-Related Macular Degeneration Phase 3