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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01589718
Recruitment Status : Withdrawn (No patients were enrolled)
First Posted : May 2, 2012
Last Update Posted : March 5, 2014
Information provided by (Responsible Party):
James C. Major, PhD, MD, Greater Houston Retina Research

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.

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Study Type : Interventional  (Clinical Trial)
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 : April 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

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 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.

Primary Outcome Measures :
  1. Tractional Retinal Detachment Repair [ Time Frame: 6 months ]
    Overall score of perceived improvement during surgery as determined by a surgeon's subjective questionnaire.

Secondary Outcome Measures :
  1. Post surgical interventions [ Time Frame: 6 Months ]
    Post surgical interventions including need for additional surgery, additional injections or PRP laser

  2. Vitreous Hemorrhage and Tractional Retinal Detachment Improvement [ Time Frame: 6 months ]
    Pre and perioperative fundus photo comparisons on an objective scale

  3. Adverse Events [ Time Frame: 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

  4. Visual Acuity [ Time Frame: 6 months ]
    Visual acuity as measured by BCVA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01589718

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United States, Texas
Retina Consultants of Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Greater Houston Retina Research
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Principal Investigator: James C Major, MD PI
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Responsible Party: James C. Major, PhD, MD, Principal Investigator, Greater Houston Retina Research Identifier: NCT01589718    
Other Study ID Numbers: No-Crunch 01
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014
Keywords provided by James C. Major, PhD, MD, Greater Houston Retina Research:
Proliferative Diabetic Retinopathy
Tractional Retinal Detachment
Vitreous Hemorrhage
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Retinal Detachment
Vitreous Hemorrhage
Pathologic Processes
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Eye Hemorrhage