CClinicalTrials.gg
CompletedNCT00088192Updated Aug 30, 2005

Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)

An interventional study of pegaptanib sodium in Macular Degeneration, sponsored by Eyetech Pharmaceuticals. Completed at 20 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2005-08-30.

Sponsored by Eyetech Pharmaceuticals · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
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Study summary

To provide Pegaptanib sodium injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD, who are unable to participate in any of the Sponsor's other clinical studies with this drug for AMD, until such time as the patient's lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist, or product becomes commercially available.

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Conditions studied

  • Macular Degeneration

Keywords

  • AMD
  • Age-Related Macular Degeneration
  • Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization
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In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

Browse Macular Degeneration studies →

Lead sponsor

Eyetech Pharmaceuticals is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Best corrected visual acuity in the study eye between 20/40 and 20/320.
  • Subfoveal choroidal neovascularization, secondary to age related macular degeneration, with a total lesion size [including blood, scar/atrophy \& neovascularization] of \< 12 total disc areas, of which at least 50% must be active CNV.
  • Any subretinal hemorrhage must comprise no more than 50% of total lesion size.

General Criteria:

  • Patients of either gender, aged greater than 50 years.
  • Women must be using two forms of effective contraception, or be post-menopausal for at least 12 months prior to study entry, or surgically sterile. If of child-bearing potential, a serum pregnancy test must be performed within 48 hours prior to treatment and the result made available prior to treatment initiation. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication.
  • Written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Any subfoveal scarring or atrophy and no more than 25% of the total lesion size may be made up of scarring or atrophy.
  • Patients who are eligible for PDT with Visudyne
  • Patients who are eligible for any other of the Sponsor's ongoing AMD studies still open to enrollment.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

  • Drugpegaptanib sodium
06

Study locations

20 sites
  • Doheny Eye Institute
    Los Angeles, California 90033, United States
  • Connecticut Retina Consultants, L.L.C.
    Bridgeport, Connecticut 06606, United States
  • New England Retina Associates
    Hamden, Connecticut 06518, United States
  • Retina Health Center
    Fort Myers, Florida 33901, United States
  • Retina Associates
    New Orleans, Louisiana 70155, United States
  • Cumberland Valley Retina Center
    Hagerstown, Maryland 21740, United States
  • New England Eye Center
    Boston, Massachusetts 02111, United States
  • Ophthalmic Consultants of Boston
    Boston, Massachusetts 02114, United States
  • Associated Retinal Consultants
    Royal Oak, Michigan 48073, United States
  • Eye Foundation of Kansas City
    Kansas City, Missouri 64108, United States
  • The Eye Center of Concord
    Concord, New Hampshire 03301, United States
  • Vitreo- Retinal Assoc. of NJ
    Belleville, New Jersey 07109, United States
  • Retina Associates of New Jersey, P.A.
    Teaneck, New Jersey 07666, United States
  • L.I. Vitreo-Retinal Consultants
    Great Neck, New York 11021, United States
  • Retina Associates of Cleveland Inc.
    Lakewood, Ohio 44107, United States
  • Dean A. McGee Eye Institute
    Oklahoma City, Oklahoma 73104, United States
  • The Casey Eye Institute
    Portland, Oregon 97239, United States
  • Palmetto Retina Center
    Columbia, South Carolina 29204, United States
  • Valley Retina Associates, P.A.
    McAllen, Texas 78503, United States
  • University of Vermont College of Medicine
    Burlington, Vermont 05401, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00088192
Lead sponsor
Eyetech Pharmaceuticals
Collaborators
Pfizer
First posted
Jul 22, 2004
Start date
Jul 2004
Last update
Aug 30, 2005
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2005. You cannot join it, but the record below documents what was studied.

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