Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
NCT00088283
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Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO) | ||
| Official Title ICMJE | 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 | ||
| Brief 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. | ||
| 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. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 2 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | ||
| Condition ICMJE | Retinal Vein Occlusion | ||
| Intervention ICMJE | Drug: pegaptanib sodium | ||
| Study Arms ICMJE | Not Provided | ||
| Publications * | 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. doi: 10.1001/archophthalmol.2009.14. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE | 90 | ||
| Original Enrollment ICMJE | Same as current | ||
| Study Completion Date ICMJE | Not Provided | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00088283 | ||
| Other Study ID Numbers ICMJE | EOP 1011B | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Not Provided | ||
| Study Sponsor ICMJE | Eyetech Pharmaceuticals | ||
| Collaborators ICMJE | Pfizer | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Eyetech Pharmaceuticals | ||
| Verification Date | January 2007 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||