Avastin for PDR (Proliferative Diabetic Retinopathy)

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT01270542
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Avastin (bevacizumab) — DRUG
    single 0.05 mL intravitreal injection of bevacizumab 1.25 mg
  • Sham injection — OTHER
    Subject's eyes will be anesthetized but no injection will be performed.

Study Details

The purpose of this study is to determine the effect of anti-VEGF drug (Avastin) adminstration in eyes prior to surgical treatment for Traction retinal detachment (TRD) in patients with Proliferative Diabetic Retinopathy (PDR).

Key Dates

First listed
Jan 5, 2011
Start date
Jun 30, 2009
Status verified
May 2014
Primary completion
Jul 31, 2011
Completion
Jul 31, 2012

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Avastin Injection Group (AIG)
    Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
  • Sham Comparator: Sham Injection Group (SIG)
    Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.

Primary Outcome Measure

The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR [ Time Frame: 3 months after last surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033-

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