Status:
COMPLETED
Effect of Macugen(Pegaptanib)on Surgical Outcomes and VEGF Levels in Diabetic Patients With PDR (Diabetic Retinopathy or CSDME (Macular Edema)
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Pfizer
Conditions:
Proliferative Diabetic Retinopathy
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with proliferative diabetic retinopathy or clinically significant diabetic macular edema requiring surgical intervention will receive a pre-operative injection of Macugen. An initial, pre-inj...
Detailed Description
Diabetes is one of the leading causes of blindness in North America. Diabetic retinopathy (PDR) is characterized by disruption of the normal microvascular circulation in the retina and results in the ...
Eligibility Criteria
Inclusion
- 18 years or older
- Type 1 or 2 diabetes
- patients requiring surgical intervention for complications of proliferative diabetic retinopathy with vitreous hemorrhage or traction retinal detachment or clinically significant macular edema
- women postmenopausal for 12 months before the study, surgically sterile, or not pregnant and on effective contraception.
Exclusion
- previous retinal vein occlusion.
- any intraocular surgery within the previous 12 months.
- myopia of \> or = to 8 diopters.
- active ocular or periocular infection
- treatment with an investigational agent for any condition 60 days prior to enrollment.
- evidence of severe cardiac disease.
- clinically significant peripheral vascular disease (previous surgery, amputation, or symptoms of claudication)
- uncontrolled hypertension (treated systolic blood pressure \> 155 mmHg or diastolic blood pressure \> 95 mmHg)
- stroke within the preceding 12 months.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00446381
Start Date
October 1 2006
End Date
September 1 2008
Last Update
April 19 2012
Active Locations (1)
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1
Ivey Eye Institute, St. Joseph's Health Care Centre
London, Ontario, Canada, N6A 4G5