Effect of Macugen(Pegaptanib)on Surgical Outcomes and VEGF Levels in Diabetic Patients With PDR (Diabetic Retinopathy or CSDME (Macular Edema)

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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-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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborator: Pfizer
• Treatments: Endothelial Growth Factors

Criteria

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.