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A Study of the Safety, Tolerability, and Efficacy of IVT Pre-op 0.3mg Pegaptanib Sodium Versus Sham, for Management of Tractional Retinal Detachment and Vitreous Hemorrhage With Proliferative Diabetic Retinopathy

NCT01589718 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-03-05

No results posted yet for this study

Summary

The purpose of this study is to assess whether preoperative pegaptanib sodium safely improves vitreous hemorrhage prior to surgical intervention and to evaluate the stability of pre-existing tractional retinal detachment.

Conditions

  • Proliferative Diabetic Retinopathy

Interventions

DRUG

Macugen

one intravitreal injection of Macugen prior to vitrectomy surgery

DRUG

Sham

The subject in cohort 2 will receive one sham comparator, sham injection prior to vitreous surgery.

Sponsors & Collaborators

  • Greater Houston Retina Research

    lead OTHER

Principal Investigators

  • James C Major, MD · PI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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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 NCT01589718 on ClinicalTrials.gov