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

NCT00446381 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-04-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Macugen (pegaptanib)

Pegaptanib 0.3 mg by intravitreal injection once pre-operatively

DRUG

Macugen (Pegaptanib)

Pegaptanib 0.3 mg by intravitreal injection once pre-operatively.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Thomas G. Sheidow, MD · Ivey Eye Institute, St. Joseph's Health Care Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00446381 on ClinicalTrials.gov