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)

March 4, 2014 updated by: James C. Major, PhD, MD, Greater Houston Retina Research

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Retina Consultants of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tractional Retinal Detachment Repair
Time Frame: 6 months
Overall score of perceived improvement during surgery as determined by a surgeon's subjective questionnaire.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post surgical interventions
Time Frame: 6 Months
Post surgical interventions including need for additional surgery, additional injections or PRP laser
6 Months
Vitreous Hemorrhage and Tractional Retinal Detachment Improvement
Time Frame: 6 months
Pre and perioperative fundus photo comparisons on an objective scale
6 months
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
6 months
Visual Acuity
Time Frame: 6 months
Visual acuity as measured by BCVA
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Greater Houston Retina Research

Investigators

  • Principal Investigator: James C Major, MD, PI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

April 27, 2012

First Submitted That Met QC Criteria

April 30, 2012

First Posted (ESTIMATE)

May 2, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 5, 2014

Last Update Submitted That Met QC Criteria

March 4, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No-Crunch 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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