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)

This study has been withdrawn prior to enrollment.
(No patients were enrolled)
Sponsor:
Information provided by (Responsible Party):
James C. Major, PhD, MD, Greater Houston Retina Research
ClinicalTrials.gov Identifier:
NCT01589718
First received: April 27, 2012
Last updated: March 4, 2014
Last verified: March 2014
  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:


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


Enrollment: 0
Study Start Date: April 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
Retina Consultants of Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Greater Houston Retina Research
Investigators
Principal Investigator: James C Major, MD PI
  More Information

Publications:
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: March 4, 2014
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:
Retinal Diseases
Diabetic Retinopathy
Retinal Detachment
Vitreous Hemorrhage
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Eye Hemorrhage
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014