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 Overview
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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.

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.

Official Title
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A Phase III Randomized 1:1, Masked, Study of the Safety, Tolerability, and Efficacy of Intravitreal Pre-op 0.3mg Pegaptanib Sodium Versus Sham, for Adjuvant Management of TRD and Vit Hem Associated With PDR

Conditions
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Proliferative Diabetic Retinopathy

Intervention / Treatment
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* Drug: Macugen
* Drug: Sham


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.3mg Pegaptanib Sodium, Macugen<br>will receive Macugen intravitreal injection prior to surgery | Drug: Macugen<br>* one intravitreal injection of Macugen prior to vitrectomy surgery<br>* Other names: 0.3mg Pegaptanib Sodium, Macugen;|
| Sham Comparator: Sham injection<br>will receive a sham injection | Drug: Sham<br>* The subject in cohort 2 will receive one sham comparator, sham injection prior to vitreous surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tractional Retinal Detachment Repair | Overall score of perceived improvement during surgery as determined by a surgeon's subjective questionnaire. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post surgical interventions | Post surgical interventions including need for additional surgery, additional injections or PRP laser | 6 Months | 
| Vitreous Hemorrhage and Tractional Retinal Detachment Improvement | Pre and perioperative fundus photo comparisons on an objective scale | 6 months | 
| Adverse Events | Incidence and severity of ocular and nonocular adverse events, such as redetachment, progression to neovascular glaucoma, endophthalmitis, etc. through post operative month 3 | 6 months | 
| Visual Acuity | Visual acuity as measured by BCVA | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tractional Retinal Detachment, Vitreous Hemorrhage, Proliferative Diabetic Retinopathy