No-Crunch01: 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

Sponsor

Greater Houston Retina Research (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01589718

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Proliferative Diabetic Retinopathy	Drug: Macugen Drug: Sham	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 0.3mg Pegaptanib Sodium, Macugen will receive Macugen intravitreal injection prior to surgery	Drug: Macugen one intravitreal injection of Macugen prior to vitrectomy surgery Other Names: 0.3mg Pegaptanib Sodium, Macugen
Sham Comparator: Sham injection will receive a sham injection	Drug: Sham The subject in cohort 2 will receive one sham comparator, sham injection prior to vitreous surgery.

Arm

Intervention/Treatment

Experimental: 0.3mg Pegaptanib Sodium, Macugen

will receive Macugen intravitreal injection prior to surgery

Drug: Macugen

one intravitreal injection of Macugen prior to vitrectomy surgery

Other Names:

0.3mg Pegaptanib Sodium, Macugen

Sham Comparator: Sham injection

will receive a sham injection

Drug: Sham

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

Outcome Measures

Primary Outcome Measures

Tractional Retinal Detachment Repair [6 months]
Overall score of perceived improvement during surgery as determined by a surgeon's subjective questionnaire.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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