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

Last updated: March 4, 2014
Sponsor: Greater Houston Retina Research
Overall Status: Trial Not Available

Phase

3

Condition

Diabetic Retinopathy

Diabetic Vitreous Hemorrhage

Retina

Treatment

N/A

Clinical Study ID

NCT01589718
No-Crunch 01
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Best corrected visual acuity in the study eye between 20/30 and light perception (LP)

  • Willingness to provide signed informed consent and Health Insurance Portability andAccountability Act (HIPAA) authorization

  • Age ≥ 18 years

  • For sexually active women of childbearing potential, agreement to the use of anappropriate form of contraception (or abstinence) for the duration of the study

Exclusion

Exclusion Criteria:

  • History of anti-VEGF treatment in the study eye

  • History of previous pars plana vitrectomy in the study eye

  • Intraocular surgery in the study eye within one month of the study

  • Patients with extensive vitreous hemorrhage in conjunction with a rhegmatogenousretinal detachment

  • Tractional retinal detachment from causes inconsistent with PDR, such as inflammationor trauma

  • Any concurrent intraocular condition in the study eye that could either requiremedical or surgical intervention during the study period to prevent or treat visualloss that might result from that condition or if allowed to progress untreated couldlikely contribute to loss of at least 2 Snellen equivalent lines of BCVA over thestudy period.

  • Active intraocular inflammation (grade trace or above) in the study eye

  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in eithereye

  • Uncontrolled glaucoma in the study eye (defined as IOP≥ 35 mmHg despite treatment withanti-glaucoma medication)

  • History of glaucoma-filtering surgery in the study eye

  • History of corneal transplant in the study eye

Study Design

Study Start date:
April 01, 2012
Estimated Completion Date:
March 31, 2014

Study Description

Patients undergoing pars plana vitrectomy for active PDR with TRD will receive a single intravitreal pre-operative 0.3mg Macugen™ prior to surgery versus sham injection.

Specific timing of the injection will be at no sooner than 7 days and no longer than 14 days prior to surgery.

Patients will receive a preinjection fundus photo and another post injection photo the day of surgery as dictated by the operative schedule.

Some photos may be limited secondary to vitreous hemorrhage. Follow up visits after surgery will be one day, one week, one month, and three months.

Connect with a study center

  • Retina Consultants of Houston

    Houston, Texas 77030
    United States

    Site Not Available

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