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

Sponsor:	Eyetech Pharmaceuticals
Collaborator:	Pfizer
Information provided by:	Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00088283

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Pegaptanib sodium

U.S. FDA Resources

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

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:

Sponsor's Website This link exits the ClinicalTrials.gov site

No publications provided by Eyetech Pharmaceuticals

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Wroblewski JJ, Wells JA 3rd, Adamis AP, Buggage RR, Cunningham ET Jr, Goldbaum M, Guyer DR, Katz B, Altaweel MM; Pegaptanib in Central Retinal Vein Occlusion Study Group. Pegaptanib sodium for macular edema secondary to central retinal vein occlusion. Arch Ophthalmol. 2009 Apr;127(4):374-80.

Study ID Numbers:	EOP 1011B
Study First Received:	July 23, 2004
Last Updated:	January 17, 2007
ClinicalTrials.gov Identifier:	NCT00088283 History of Changes
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:

Macular Edema
Embolism and Thrombosis
Eye Diseases
Retinal Vein Occlusion
Vascular Diseases
Retinal Degeneration

Macular Degeneration
Cardiovascular Diseases
Venous Thrombosis
Thrombosis
Retinal Diseases

ClinicalTrials.gov processed this record on February 08, 2010