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An Open Label Trial to Investigate Macugen for the Preservation of Visual Function in Subjects With Neovascular AMD (PERSPECTIVES)
This study has been terminated.
( There were no safety or efficacy issues for the termination; the decision was for administrative reasons. )
First Received: May 17, 2006   Last Updated: August 5, 2009   History of Changes
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00327470
  Purpose

The purpose of this study is to determine the benefits of treating subjects with neovascular age-related macular degeneration (AMD) at an earlier stage of choroidal neovascularization (CNV) as compared to those with established CNV. Additionally, the study would like to determine the efficacy of Macugen in preserving visual function in those subjects having CNV secondary to neovascular AMD.


Condition Intervention Phase
Age Related Macular Degeneration (AMD)
Macular Degeneration
Choroidal Neovascularization (CNV)
 Drug: Pegaptanib Sodium 0.3 mg
 Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: A 102-week, Open Label, Multicenter Trial to Investigate the Efficacy of Macugen for the Preservation of Visual Function in Subjects With Neovascular Age-related Macular Degeneration (AMD) and to Assess the Benefit of Treating Early Choroidal Neovascularization (CNV).

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Macular Degeneration
Drug Information available for: Pegaptanib sodium
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The mean change in distance visual acuity from baseline to week 54 in subjects with early and established CNV lesions by assessing the best corrected visual acuity as measured by ETDRS score. [ Time Frame: Baseline to Wk 54 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The mean change in near visual acuity from baseline in subjects with early and established CNV lesions at Weeks 54 and 102 [ Time Frame: Wk 54 - Wk 102 ] [ Designated as safety issue: No ]
  • The mean change in near visual acuity from Week 54 to Week 102 [ Time Frame: Wk 54 - Wk 102 ] [ Designated as safety issue: No ]
  • The mean change in reading speed in subjects with early and established CNV lesions from baseline at Weeks 54 and 102 and from Week 54 to Week 102 [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • The mean change in contrast sensitivity in subjects with early and established CNV lesions from baseline at Week 54 and Week 102 [ Time Frame: Wk 54 - Wk 102 ] [ Designated as safety issue: No ]
  • The mean change in NEI-VFQ composite score and EQ5D score from baseline in subjects with early and established CNV lesions at Weeks 54 and 102 [ Time Frame: Wk 54 - Wk 102 ] [ Designated as safety issue: No ]
  • Mean change in distance visual acuity from baseline to 102 weeks and from Week 54 to Week 102 in subjects with early and established CNV lesions [ Time Frame: baseline-102 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 370
Study Start Date: July 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Open Label: Experimental Drug: Pegaptanib Sodium 0.3 mg
Pegaptanib Sodium dosed every 6 weeks in affected eye.

  Eligibility

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

Inclusion Criteria:

  • Evidence of neovascular AMD in at least one eye. In subjects with bilateral neovascular AMD, only one eye would be eligible for enrollment
  • Baseline visual acuity of greater than or equal to 20/320, or better than 25 ETDRS letters in the study eye

Exclusion Criteria:

  • Previous treatment for CNV secondary to AMD, including any prior PDT with verteporfin, thermal laser photocoagulation, external beam radiation or transpupillary thermotherapy to the study eye
  • Subjects having subfoveal fibrosis/ scar or atrophy representing > 25% of the total lesion size
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327470

  Show 58 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A5751017
Study First Received: May 17, 2006
Last Updated: August 5, 2009
ClinicalTrials.gov Identifier: NCT00327470     History of Changes
Health Authority: Turkey:Ministry of Health Central Ethics Committee

Keywords provided by Pfizer:
neovascular age related macular degeneration, choroidal neovascularization

Study placed in the following topic categories:
Uveal Diseases
Metaplasia
Eye Diseases
Choroid Diseases
Retinal Degeneration
 Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization

Additional relevant MeSH terms:
Uveal Diseases
Pathologic Processes
Metaplasia
Eye Diseases
Choroid Diseases
 Retinal Degeneration
Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization

ClinicalTrials.gov processed this record on September 01, 2009



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