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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 is currently recruiting patients.
| Sponsored by: | Eyetech Pharmaceuticals
Pfizer
|
|---|---|
| Information provided by: | Eyetech Pharmaceuticals |
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. Neither the patient nor the treating ophthalmologist will know to which study injection the patient has been assigned. The ophthalmologist administering the injection will have this information.
Participation in this study will last approximately 1 year.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Macular Degeneration |
Drug: pegaptanib sodium |
Phase II |
MedlinePlus related topics: Macular Degeneration
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
Expected Total Enrollment: 90
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. Below is a description of each phase.
Screening Phase
The screening procedures will take approximately three to four hours and will be used to determine if the patient is medically eligible for this study. These tests can be performed in one or more visits over a two-week period of time. The following procedures will take place:
- Visual acuity exam to check the patient’s vision in both eyes - Ophthalmic exam to check the front and back part of the patient’s eyes - Procedure to check the pressure in the patient’s eyes - Photos/imaging of the back of the patient’s eyes - Physical exam (not including a vaginal, rectal, or breast exam) - Blood tests for routine blood function, liver function, and kidney function - Blood test for pregnancy, only for woman of child bearing potential - Electrocardiogram (ECG), a painless test to monitor the patient’s heart rate and its rhythm - Vital sign assessments to check the patient’s blood pressure, weight, and height
If the screening evaluations indicate that the patient qualifies for the study, the patient will be asked to return to the clinic within two weeks.
Confirmation Phase
This phase will last approximately one hour and will be used to confirm the patient is still eligible for participation. The following procedure will take place:
- Photos/imaging of the back of the patient’s eye with CRVO
If the confirmation evaluations indicate the patient still qualifies for the study, the patient will immediately enter the randomization phase.
Randomization Phase
This phase will last approximately 52 weeks. The following procedures will take place approximately every 6 weeks:
- Visual acuity exam to check the patient’s vision - Ophthalmic exam to check the front and back part of the patient’s eyes - Procedure to check the pressure in the patient’s eyes - Photos/imaging of the back of the patient’s eyes - Physical exam (if the patient’s eye doctor feels it is necessary) - Blood tests for routine blood function, liver function, and kidney function - Blood tests to determine the level of medication, if any, in the blood - Vital sign assessments to check the patient’s blood pressure - Intravitreous injection of either Macugen™ or ”pretend” injection - Telephone safety call
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
Ophthalmic Criteria CRVO
General Criteria
Exclusion Criteria:
Location
and Contact
Information
More Information
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