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

Phase 1

Completed

• Conditions: Wet Age-Related Macular Degeneration
• Interventions: Drug: PTK787; Drug: Placebo

• Registration Number: NCT00138632
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-30
• Study Start: 2005-09
• Primary Completion: 2007-11
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-12
• Last Update Posted: 2008-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	PTK787	-
2	PTK787	-
3	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Novartis Investigational Site; 🇦🇺 Sydney, New South Wales, Australia

Wilmer Eye Institute; 🇺🇸 Baltimore, Maryland, United States

Retina-Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

Springfield Clinic, LLP; 🇺🇸 Springfield, Illinois, United States

USF Eye Institute; 🇺🇸 Tampa, Florida, United States

Lahey Clinic Medical Center, Eye institute; 🇺🇸 Peabody, Massachusetts, United States

Black Hills Regional Eye Institute; 🇺🇸 Rapid City, South Dakota, United States

Novartis Investigative Site; 🇦🇺 East Melbourne, Victoria, Australia

Porter Adventist Hospital, Eye Lab; 🇺🇸 Denver, Colorado, United States