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
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
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 15, 2014