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 - Full Text View

Purpose

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	Intervention	Phase
Proliferative Diabetic Retinopathy	Drug: Macugen Drug: Sham	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders

Drug Information available for: Pegaptanib sodium

U.S. FDA Resources

Further study details as provided by Greater Houston Retina Research:

Primary Outcome Measures:

Tractional Retinal Detachment Repair [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Overall score of perceived improvement during surgery as determined by a surgeon's subjective questionnaire.

Secondary Outcome Measures:

Post surgical interventions [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Post surgical interventions including need for additional surgery, additional injections or PRP laser
Vitreous Hemorrhage and Tractional Retinal Detachment Improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Pre and perioperative fundus photo comparisons on an objective scale
Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Visual acuity as measured by BCVA

Estimated Enrollment:	20
Study Start Date:	April 2012
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589718

Contacts

Contact: James C Major, MD	713-524-3434	jcmmd@houstonretina.com
Contact: Karri L Schuetzle	713-394-7534	karri.schuetzle@houstonretina.com

Locations

United States, Texas
Retina Consultants of Houston	Recruiting
Houston, Texas, United States, 77030
Contact: Karri Schuetzle 713-394-7534 karri.schuetzle@houstonretina.com
Sub-Investigator: David M Brown, MD
Sub-Investigator: Charles C Wykoff, MD
Sub-Investigator: Tien P Wong, MD
Sub-Investigator: Rosa Y Kim, MD
Sub-Investigator: Matthew S Benz, MD
Sub-Investigator: Eric Chen, MD
Sub-Investigator: Richard H Fish, MD

Sponsors and Collaborators

Greater Houston Retina Research

Investigators

Principal Investigator:

James C Major, MD

PI

More Information

Publications:

González VH, Giuliari GP, Banda RM, Guel DA. Intravitreal injection of pegaptanib sodium for proliferative diabetic retinopathy. Br J Ophthalmol. 2009 Nov;93(11):1474-8. Epub 2009 Aug 18.

Wroblewski JJ, Wells JA 3rd, Gonzales CR. Pegaptanib sodium for macular edema secondary to branch retinal vein occlusion. Am J Ophthalmol. 2010 Jan;149(1):147-54. Epub 2009 Oct 28.

Chen E, Park CH. Use of intravitreal bevacizumab as a preoperative adjunct for tractional retinal detachment repair in severe proliferative diabetic retinopathy. Retina. 2006 Jul-Aug;26(6):699-700. No abstract available.

Responsible Party:	James C. Major, PhD, MD, Principal Investigator, Greater Houston Retina Research
ClinicalTrials.gov Identifier:	NCT01589718 History of Changes
Other Study ID Numbers:	No-Crunch 01
Study First Received:	April 27, 2012
Last Updated:	May 16, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Greater Houston Retina Research:

Proliferative Diabetic Retinopathy
Tractional Retinal Detachment
Vitreous Hemorrhage

Additional relevant MeSH terms:

Diabetic Retinopathy
Hemorrhage
Retinal Detachment
Retinal Diseases
Vitreous Hemorrhage
Eye Diseases
Diabetic Angiopathies

Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pathologic Processes
Eye Hemorrhage

ClinicalTrials.gov processed this record on June 17, 2013

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 (No-Crunch01)