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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)

Primary Purpose

Proliferative Diabetic Retinopathy

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Macugen
Sham
Sponsored by
Greater Houston Retina Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Proliferative Diabetic Retinopathy, Tractional Retinal Detachment, Vitreous Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Retina Consultants of Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

0.3mg Pegaptanib Sodium, Macugen

Sham injection

Arm Description

will receive Macugen intravitreal injection prior to surgery

will receive a sham injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Post surgical interventions
Post surgical interventions including need for additional surgery, additional injections or PRP laser
Vitreous Hemorrhage and Tractional Retinal Detachment Improvement
Pre and perioperative fundus photo comparisons on an objective scale
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
Visual Acuity
Visual acuity as measured by BCVA

Full Information

First Posted
April 27, 2012
Last Updated
March 4, 2014
Sponsor
Greater Houston Retina Research
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1. Study Identification

Unique Protocol Identification Number
NCT01589718
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Withdrawn
Why Stopped
No patients were enrolled
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Greater Houston Retina Research

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy
Keywords
Proliferative Diabetic Retinopathy, Tractional Retinal Detachment, Vitreous Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.3mg Pegaptanib Sodium, Macugen
Arm Type
Experimental
Arm Description
will receive Macugen intravitreal injection prior to surgery
Arm Title
Sham injection
Arm Type
Sham Comparator
Arm Description
will receive a sham injection
Intervention Type
Drug
Intervention Name(s)
Macugen
Other Intervention Name(s)
0.3mg Pegaptanib Sodium, Macugen
Intervention Description
one intravitreal injection of Macugen prior to vitrectomy surgery
Intervention Type
Drug
Intervention Name(s)
Sham
Intervention Description
The subject in cohort 2 will receive one sham comparator, sham injection prior to vitreous surgery.
Primary Outcome Measure Information:
Title
Tractional Retinal Detachment Repair
Description
Overall score of perceived improvement during surgery as determined by a surgeon's subjective questionnaire.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Post surgical interventions
Description
Post surgical interventions including need for additional surgery, additional injections or PRP laser
Time Frame
6 Months
Title
Vitreous Hemorrhage and Tractional Retinal Detachment Improvement
Description
Pre and perioperative fundus photo comparisons on an objective scale
Time Frame
6 months
Title
Adverse Events
Description
Incidence and severity of ocular and nonocular adverse events, such as redetachment, progression to neovascular glaucoma, endophthalmitis, etc. through post operative month 3
Time Frame
6 months
Title
Visual Acuity
Description
Visual acuity as measured by BCVA
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James C Major, MD
Organizational Affiliation
PI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19692371
Citation
Gonzalez 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.
Results Reference
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PubMed Identifier
19875087
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.
Results Reference
background
PubMed Identifier
16829817
Citation
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. doi: 10.1097/01.iae.0000225351.87205.69. No abstract available.
Results Reference
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Learn more about this trial

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

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