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

Proliferative Diabetic Retinopathy Clinical Trial

— No-Crunch01  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01589718
• Other study ID #: No-Crunch 01
• Status: Withdrawn
• Phase: Phase 3
• First received: April 27, 2012
• Last updated: March 4, 2014
• Start date: April 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Greater Houston Retina Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Detachment
• Retinal Diseases
• Vitreous Hemorrhage

Intervention

Drug:
• Macugen
one intravitreal injection of Macugen prior to vitrectomy surgery
• Sham
The subject in cohort 2 will receive one sham comparator, sham injection prior to vitreous surgery.

Locations

Country	Name	City	State
United States	Retina Consultants of Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Greater Houston Retina Research

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. doi: 10.1136/bjo.2008.155663. Epub 2009 Aug 18. — View Citation

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. doi: 10.1016/j.ajo.2009.08.005. Epub 2009 Oct 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tractional Retinal Detachment Repair	Overall score of perceived improvement during surgery as determined by a surgeon's subjective questionnaire.	6 months	No
Secondary	Post surgical interventions	Post surgical interventions including need for additional surgery, additional injections or PRP laser	6 Months	No
Secondary	Vitreous Hemorrhage and Tractional Retinal Detachment Improvement	Pre and perioperative fundus photo comparisons on an objective scale	6 months	No
Secondary	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	Yes
Secondary	Visual Acuity	Visual acuity as measured by BCVA	6 months	No