Study of the Safety, Tolerability and Pharmacokinetics of 1 Mg/Eye and 3 Mg/Eye Pegaptanib Sodium in Patients With Exudative Age-Related Macular Degeneration (AMD)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00215670
First received: September 14, 2005
Last updated: May 2, 2006
Last verified: May 2006
  Purpose

The objectives of this study are to characterize the safety, tolerability and pharmacokinetics of pegaptanib when given as 1 or 3mg/eye intravitreous injections every 6 weeks for 54 weeks in patients with subfoveal choroidal neovascularization (CNV) secondary to AMD.


Condition Intervention Phase
Age-Related Macular Degeneration
Drug: pegaptanib sodium (Macugen)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Masked, Multi-Center Trial of the Safety, Tolerability and Pharmacokinetics of 1 Mg/Eye and 3 Mg/Eye Intravitreal Injections of Pegaptanib Sodium (Anti-Vegf Pegylated Aptamer) Given Every 6 Weeks for 54 Weeks, in Patients With Exudative Age-Related Macular Degeneration (AMD)

Resource links provided by NLM:


Further study details as provided by Eyetech Pharmaceuticals:

Estimated Enrollment: 125
Study Start Date: November 2002
Estimated Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Best corrected visual acuity in the study eye between 20/40 and 20/320 and better or equal to 20/800 in the fellow eye.

Subfoveal CNV, secondary to AMD, w/ a total lesion size [including blood, scar/atrophy & neovascularization] of less than or equal to 12 disc areas, of which at least 50% must be active CNV.

Patients of either sex, aged greater than or equal to 50 years.

Exclusion Criteria:

Previous subfoveal thermal laser therapy. Any subfoveal scarring or atrophy & no more than 25% of the total lesion size may be made up of scarring or atrophy.

More than one prior PDT w/ Visudyne is not permitted. Pts may not have rec'd their 1st PDT w/in less than 8 wks or more than 13 wks prior to the BSL angiography/photography for the study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00215670     History of Changes
Other Study ID Numbers: EOP1006
Study First Received: September 14, 2005
Last Updated: May 2, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Eyetech Pharmaceuticals:
AMD
Macugen
Pharmacokinetics
Age-Related Macular Degeneration
PK

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 22, 2014