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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Proliferative Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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0.3mg Pegaptanib Sodium, Macugen

will receive Macugen intravitreal injection prior to surgery

Group Type EXPERIMENTAL

Macugen

Intervention Type DRUG

one intravitreal injection of Macugen prior to vitrectomy surgery

Sham injection

will receive a sham injection

Group Type SHAM_COMPARATOR

Sham

Intervention Type DRUG

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

Interventions

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Macugen

one intravitreal injection of Macugen prior to vitrectomy surgery

Intervention Type DRUG

Sham

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

Intervention Type DRUG

Other Intervention Names

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0.3mg Pegaptanib Sodium, Macugen

Eligibility Criteria

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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 and Accountability Act (HIPAA) authorization
* Age ≥ 18 years
* For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study

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 rhegmatogenous retinal detachment
* Tractional retinal detachment from causes inconsistent with PDR, such as inflammation or trauma
* Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition or if allowed to progress untreated could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the study period.
* Active intraocular inflammation (grade trace or above) in the study eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Uncontrolled glaucoma in the study eye (defined as IOP≥ 35 mmHg despite treatment with anti-glaucoma medication)
* History of glaucoma-filtering surgery in the study eye
* History of corneal transplant in the study eye

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No