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COMPLETED Phase 2

Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)

NCT00088283 · View on ClinicalTrials.gov ↗

Study Summary

Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug, MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This investigational drug may slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the eye. The purpose of this study is to compare the safety and efficacy of a Macugen™ injection to a "pretend" injection. In addition, the purpose of this study is to measure the action of the study drug in the body over a period of time and to check for the presence of the study drug in your blood (called pharmacokinetics or PK). This study will involve approximately 90 people. People who decide to participate will have an equal chance (1 in 3) to receive one of three study injections, two of which are Macugen™ and one of which is a "pretend" injection.

Conditions Studied

Interventions

  • DRUG pegaptanib sodium

Study Locations (20)

Massachusetts

  • New England Eye Center — Boston
  • Massachusetts Eye & Ear Infirmary — Boston
  • Lahey Clinic, The Eye Institute — Peabody

Arizona

  • Retina Centers, P.C., Northwest Location — Tucson
  • Retina Associates, SW — Tucson

California

  • Jules Stein Institute — Los Angeles
  • Orange County Retina Associates — Santa Ana

Florida

  • Retina Group of Florida — Fort Lauderdale
  • Bascom Palmer Eye Institute — Miami

Maryland

  • Retina Group of Washington — Chevy Chase
  • Cumberland Valley Retina Center — Hagerstown

Michigan

  • Kresge Eye Institute — Detroit
  • Associated Retinal Consultants — Royal Oak

Connecticut

  • New England Retina Associates — Hamden

Illinois

  • The University of Chicago — Chicago

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2004-05
Phase Phase 2

Sponsor

Eyetech Pharmaceuticals

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00088283

The ClinicalTrials.gov registry entry for NCT00088283 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eyetech Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Retinal Vein Occlusion appearing as the primary indexed condition, and to 1 intervention — of which pegaptanib sodium is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00088283 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Massachusetts, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00088283 about?

NCT00088283 is a clinical study titled "Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)". Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug, MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This investigational drug may slow the growth of abnormal blood...

What is the current status of trial NCT00088283?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2004-05.

What conditions does trial NCT00088283 study?

This clinical trial studies the following conditions: Retinal Vein Occlusion. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00088283?

The interventions under investigation include: pegaptanib sodium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00088283?

This trial is sponsored by Eyetech Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00088283 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial