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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00088283
First received: July 23, 2004
Last updated: January 17, 2007
Last verified: January 2007
  Purpose

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.


Condition Intervention Phase
Retinal Vein Occlusion
Drug: pegaptanib sodium
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Dose-Ranging, Double-Masked, Multi-Center Trial, in Parallel Groups, Determining Safety, Efficacy and PK of Intravitreous Injections of Pegaptanib Sodium Compared to Sham Injection for 30 Weeks in Patients With Recent Vision Loss Due to Macular Edema Secondary to CRVO

Resource links provided by NLM:


Further study details as provided by Eyetech Pharmaceuticals:

Estimated Enrollment: 90
Study Start Date: May 2004
Detailed Description:

This study will consist of 3 phases: a screening phase which will last up to two weeks, a confirmation phase which will last one day, and a randomization phase (the patient will be assigned by chance to a study group in this phase) which will last approximately 52 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CRVO must have occurred within the past 6 months and be associated with macular edema determined by OCT.
  • Vision in the study eye corresponding to between approximately 20/50 to 20/400 and better than or equal to approximately 20/200 in the fellow eye.

Exclusion Criteria:

  • Presence of signs of old branch retinal vein occlusion (BRVO) or CRVO in the study eye or any other retinal vascular disease including diabetic retinopathy.
  • Vitreous hemorrhage except breakthrough hemorrhage from intraretinal hemorrhage.
  • Prior pan retinal photocoagulation (PRP) or sector scatter photocoagulation.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088283

  Show 35 Study Locations
Sponsors and Collaborators
Eyetech Pharmaceuticals
Pfizer
  More Information

Additional Information:
No publications provided by Eyetech Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00088283     History of Changes
Other Study ID Numbers: EOP 1011B
Study First Received: July 23, 2004
Last Updated: January 17, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Eyetech Pharmaceuticals:
CRVO
Central Retinal Vein Occlusion
RVO
Retinal Vein Occlusion

Additional relevant MeSH terms:
Retinal Vein Occlusion
Macular Edema
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Macular Degeneration
Retinal Degeneration

ClinicalTrials.gov processed this record on September 16, 2014