Diabetic Macular Edema Clinical Trial
— PEGAP001Official title:
Effect of Macugen (Pegaptanib) on Surgical Outcomes and Growth Factors Including Vascular Endothelial Growth Factor (VEGF) Levels in Patients With Proliferative Diabetic Retinopathy (PDR) and Clinically Significant Diabetic Macular Edema (CSDME)
Verified date | April 2012 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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-injection vitreous tap will be done in order to provide baseline VRGF 165 and cytokine levels. At the onset of the vitrectomy, a second vitreous sample will be taken to obtain intra-operative levels of Macugen, VEGF 165 and cytokines.
Status | Completed |
Enrollment | 28 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Canada | Ivey Eye Institute, St. Joseph's Health Care Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute | Pfizer |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Levels of intravitreal Macugen post injection of intravitreal Macugen. | 2 to 8 weeks | No | |
Primary | Levels of intravitreal VEGF 165 pre and post injection of intravitreal Macugen. | 0 to 8 weeks | No | |
Primary | Levels of intravitreal VEGF, TGFbeta, ET-1, PDGF, IGF-1,angiopoietin, HIF 1 alpha, HIF 1 beta pre and post injection of intravitreal Macugen. | 0 to 8 weeks | No | |
Secondary | Effect on ease of surgery post injection of intravitreal Macugen. | 2 to 8 weeks | No | |
Secondary | Effect on re-bleed rate post injection of intravitreal Macugen. | 0 to 8 weeks | No | |
Secondary | Effect on concomitant diabetic macular edema post injection of intravitreal Macugen | 0 to 8 weeks | No |
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